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Trial in corso

13-dic-2022

Ascolta

[Dati estratti dai DB internazionali www.clinicaltrials.gov  e www.clinicaltrialsregister.eu]

[L'elenco considera tutti i Trial che sono in corso di svolgimento nell'anno corrente, cioè la cui scadenza effettiva/presunta cade nell'anno corrente o in anno successivo]

[#TOT Trial in corso: 121] - [ultimo aggiornamento: 25/11/2024]

Title Multicenter, Nationwide, Observational, Prospective Study Based on the Development of a Primary Sclerosing Cholangitis Patients Database Linked to a Biological Sample Storage
NCT Number NCT05618145
PSC_Database
Conditions Primary Sclerosing Cholangitis
Interventions Other: Clinical information
Sponsor University of Milano Bicocca
Gender All
Age 17 Years and older   (Child, Adult, Older Adult)
Phases  
Enrollment 6000 participants
Study Type Observational
Study Designs Cohort
Start Date 21/10/2022
Completion Date 21/10/2032
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastroenterologia, prof.ssa Vincenza Calvaruso
URL https://www.clinicaltrials.gov/ct2/show/NCT05618145 

 

Title A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination with Ruxolitinib Versus Best Available Therapy in Subjects with Relapsed/Refractory Myelofibrosis (TRANSFORM-2)
Studio Clinico Randomizzato, In Aperto di Fase 3 per Valutare l’Efficacia e la Sicurezza di Navitoclax in Combinazione con Ruxolitinib rispetto alla Miglior Terapia Disponibile in Soggetti Affetti da Mielofibrosi Recidivante/Refrattaria
EudraCT number 2020-000557-27
TRANSFORM-2 M20-178
Conditions Myelofibrosis
Mielofibrosi
Interventions  
Sponsor ABBVIE DEUTSCHLAND GMBH & CO. KG 
Gender Female; Male
Age Adults; Elderly; 
Phases Phase III
Enrollment 330
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled; Randomised; Open; Parallel group; 
Start Date 27/10/2020
Completion Date 23/01/2032
Locations United Kingdom
Italy: A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000557-27/IT 

 

Title A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib,Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

Uno studio randomizzato di fase 3 che confronta Teclistamab in monoterapia con pomalidomide, bortezomib, desametasone (PVd) o carfilzomib, desametasone (Kd) in partecipanti con mieloma multiplo recidivante o refrattario che hanno ricevuto da 1 a 3 linee terapeutiche precedenti, incluso un anticorpo monoclonale anti-CD38 e lenalidomide
EudraCT number 2022-000928-37
6400795MMY3006
Medical condition Multiple myeloma

Mieloma multiplo
Interventions  
Sponsor JANSSEN CILAG INTERNATIONAL NV
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 590
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Open; 
Start Date 02/09/2023
Completion Date 31/08/2031
Locations A.O.U. Policlinico P. Giaccone Palermo, Dott. Cirino Botta, U.O.C. di Ematologia
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000928-37/IT 

 

Study Title Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
NCT Number NCT04468984 Other IDs: M20-178|2020-000557-27
Conditions Myelofibrosis (MF)
Interventions DRUG: Navitoclax|DRUG: Ruxolitinib|DRUG: Best Available Therapy (BAT)
Sponsor AbbVie
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 330
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 31/08/2020
Completion Date 01/02/2031
Locations U.O.C. di Ematologia, Prof. Sergio Siragusa, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04468984 

   

Study Title A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
NCT Number NCT01848561 Other IDs: P11-282
Conditions Ulcerative Colitis (UC)
Interventions  
Sponsor AbbVie
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 8250
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 29/04/2013
Completion Date 24/06/2030
Locations Dott.ssa Maria Cappello, Gastroenterologia , Direttore Prof. Calogero Cammà, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 141397, Palermo, 90127, Italy| A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 141392, Palermo, 90146, Italy|
Study URL https://clinicaltrials.gov/study/NCT01848561 

  

Study Title AutoInflammatory Disease Alliance Registry (AIDA)
NCT Number NCT05200715 Other IDs: AIDA V.04 19.05.2021
Conditions Hereditary Autoinflammatory Diseases|Schnitzler Syndrome|Behcet Syndrome|PFAPA Syndrome|Still Disease|Autoinflammatory Syndrome, Unspecified|Uveitis|Scleritis|Vexas Syndrome
Interventions OTHER: No intervention is foreseen by the protocol.
Sponsor University of Siena
Sex ALL
Age CHILD, ADULT, OLDER_ADULT
Phases  
Enrollment 3500
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 08/06/2020
Completion Date 08/06/2030
Locations ARNAS Ospedale Civico di Cristina Benfratelli, Palermo, Italy| Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy| prof.ssa Maria Cristina Maggio, University Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE) “G. D’Alessandro”, University of Palermo, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT05200715 

 

Title Shortened vs standard chemotherapy combined with immunotherapy for the initial treatment of patients with high tumor burden Follicular Lymphoma. A randomized, open label, phase III study by Fondazione Italiana Linfomi.

Trattamento combinato di immunochemioterapia standard vs immunoterapia standard e chemioterapia a ridotto numero di cicli per il trattamento in prima linea di pazienti con Linfoma Follicolare ad elevato carico tumorale. Studio randomizzato in aperto di fase III della Fondazione Italiana Linfomi.
EudraCT number 2020-003277-22
FIL FOLL 19
Conditions High tumor burden Follicular Lymphoma
Linfoma Follicolare ad elevato carico tumorale
Interventions  
Sponsor FONDAZIONE ITALIANA LINFOMI ONLUS
Gender Female; Male
Age Adults; Elderly; 
Phases Phase III
Enrollment 602
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled; Randomised; Open; 
Start Date 10/04/2021
Completion Date 25/10/2029
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott.ssa Salvatrice Mancuso
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003277-22/IT 

 

Study Title Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
NCT Number NCT04822181 Other IDs: NN9931-4553|U1111-1244-3678|2019-004594-44|jRCT2031210033
Conditions Non-alcoholic Steatohepatitis
Interventions DRUG: Semaglutide|DRUG: Placebo
Sponsor Novo Nordisk A/S
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 1200
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 04/01/2021
Completion Date 25/04/2029
Locations AOUP Giaccone Palermo, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04822181 

 

Title A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

Studio di Fase 3, randomizzato, in doppio cieco, controllato con placebo, multicentrico, per la valutazione dell’efficacia e della sicurezza a lungo termine di lanifibranor in pazienti adulti affetti da steatoepatite non alcolica (NASH) non cirrotica e da fibrosi epatica di stadio 2 (F2) e di stadio 3 (F3)
EudraCT number 2020-004986-38
Medical condition Non-alcoholic Steatohepatitis (NASH)

Steatoepatite non alcolica (NASH)
Interventions  
Sponsor/Collaborators INVENTIVA S.A.
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 2000
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Parallel group; 
Start Date 05/02/2022
Completion Date 03/02/2029
Locations France - A.O.U. Policlinico P. Giaccone Palermo, PETTA SALVATORE
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004986-38/IT 

 

Study Title National Database on Primary Biliary Cholangitis
NCT Number NCT05151809
Conditions Primary Biliary Cholangitis
Interventions OTHER: Clinical information
Sponsor University of Milano Bicocca
Gender  
Age  
Phases  
Enrollment 6000
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 19/09/2019
Completion Date 24/01/2029
Locations UO gastroenterologia, Policlinico Paolo Giaccone, Palermo, Italy, prof. Calogero Cammà
URL https://clinicaltrials.gov/study/NCT05151809 

 

Study Title A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
NCT Number NCT06016842 Other IDs: CLIN-60190-454|2023-505251-43-00
Conditions Primary Biliary Cholangitis (PBC)
Interventions DRUG: Elafibranor|OTHER: Matched 80 mg placebo
Sponsor Ipsen
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 276
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 31/08/2023
Completion Date 05/01/2029
Locations prof.ssa Vincenza Calvaruso, U.O.C. Gastroenterologia, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT06016842 

 

Title LOWER: Lomitapide Observational Worldwide Evaluation Registry
NCT Number NCT02135705
AEGR-733-025
Conditions Homozygous Familial Hypercholesterolemia
Interventions Parallel Assignment
Sponsor Amryt Pharma
Gender All
Age Child, Adult, Older Adult
Phases  
Enrollment 300
Study Type Observational [Patient Registry]
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Start Date 18/03/2014
Completion Date 01/09/2028
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof. Angelo Baldassare Cefalù, Principal Investigator
URL https://clinicaltrials.gov/ct2/show/NCT02135705 

 

Title Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to Myelodysplastic Syndromes With del5q, Refractory/Resistant/Intolerant to Prior Treatments, Who Require Red Blood Cell Transfusions
NCT Number NCT05924100
Conditions Myelodysplastic Syndromes
Del(5Q)
Anemia
Transfusion-dependent Anemia
Interventions Drug: Luspatercept Injection [Reblozyl]
Sponsor Associazione Qol-one
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 2
Enrollment 22 participants
Study Type Interventional  (Clinical Trial)
Study Designs Single Group Assignment
Start Date 03/11/2022
Completion Date 03/11/2028
Locations A.O.U. Policlinico P. Giaccone di Palermo, prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT05924100 

 

Title Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to Myelodysplastic Syndromes with del5q refractory/resistant/intolerant to Prior Treatments, Who Require Red Blood Cell Transfusion.

Efficacia e Sicurezza del Luspatercept per il Trattamento dell’Anemia dovuta alle Sindromi Mielodisplastiche con del5q refrattarie/resistenti/intolleranti a precedenti Trattamenti e che richiedono Trasfusioni di Globuli Rossi.
EudraCT number 2021-001538-20
Medical condition Anemia due to MDS with del5q with IPSS-R very low, low, or intermediate risk MDS and a bone marrow blast count of < 5% , Refractory or intolerant to, or ineligible for, prior ESA treatment and for prior lenalidomide treatment and who require RBC transfusions.

Anemia dovuta a MDS con del5q con IPSS-R MDS a rischio molto basso, basso o intermedio e una conta dei blasti del midollo osseo < 5% , refrattari o intolleranti o non idonei ad un precedente trattamento con agenti stimolanti eritropoietici (ESA) e ad un precedente trattamento con Lenalidomide e che richiedono trasfusioni di RBC
Interventions  
Sponsor/Collaborators ASSOCIAZIONE QOL-ONE
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 22
Trial type Therapeutic exploratory (Phase II)
Design of the trial  
Start Date 07/04/2022
Completion Date 05/04/2028
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo, SIRAGUSA SERGIO
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001538-20/IT 

 

Study Title A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
NCT Number NCT02130362
Other IDs: P11-292
Conditions Crohn's Disease
Interventions  
Sponsor AbbVie
Sex ALL
Age CHILD
Phases  
Enrollment 1446
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 28/08/2014
Completion Date 03/02/2028
Locations U.O. Gastroenterologia - Malattie Infiammatorie Croniche Intestinali, Prof. Calogero Cammà, Policlinico Paolo Giaccone /ID# 138410, Palermo, Sicilia, 90127, Italy|  A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684, Palermo, 90146, Italy|
Study URL https://clinicaltrials.gov/study/NCT02130362 

 

Study Title Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
NCT Number NCT04526665
Other IDs: GFT505B-319-1|2019-004941-34
Conditions Primary Biliary Cirrhosis
Interventions DRUG: Elafibranor 80mg|DRUG: Placebo
Sponsor Ipsen
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 161
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 24/09/2020
Completion Date 12/01/2028
Locations Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia - Dip.Medicina Interna e Specialistica, Palermo, 90127, Italy
Study URL https://clinicaltrials.gov/study/NCT04526665 

 

Study Title Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
NCT Number NCT02735707 Other IDs: U1111-1189-1653|2015-002340-14|602525|16/631|APP1101719|158584|2023-507889-89-00|965313
Conditions Community-acquired Pneumonia, Influenza, COVID-19
Interventions DRUG: Ceftriaxone|DRUG: Moxifloxacin or Levofloxacin|DRUG: Piperacillin-tazobactam|DRUG: Ceftaroline|DRUG: Amoxicillin-clavulanate|DRUG: Standard course macrolide|DRUG: Extended course macrolide|OTHER: No systemic corticosteroid|DRUG: Fixed-duration Hydrocortisone|DRUG: Shock-dependent hydrocortisone|DRUG: Fixed-duration higher dose Hydrocortisone|OTHER: No antiviral agent for influenza|DRUG: Five-days oseltamivir|DRUG: Ten-days oseltamivir|OTHER: No antiviral agent for COVID-19|DRUG: Lopinavir / Ritonavir|DRUG: Hydroxychloroquine|DRUG: Hydroxychloroquine + lopinavir/ritonavir|DRUG: Ivermectin|OTHER: No immune modulation for COVID-19|DRUG: Interferon beta-1a|DRUG: Anakinra|DRUG: Tocilizumab|DRUG: Sarilumab|DRUG: Local standard venous thromboprophylaxis|DRUG: Therapeutic dose anticoagulation|DRUG: Conventional low dose thromboprophylaxis|DRUG: Intermediate dose thromboprophylaxis|DRUG: Continuation of therapeutic dose anticoagulation|OTHER: No immunoglobulin|BIOLOGICAL: Convalescent plasma|BIOLOGICAL: Delayed administration of convalescent plasma|OTHER: No vitamin C|DRUG: Vitamin C|OTHER: No antiplatelet|DRUG: Aspirin|DRUG: P2Y12 inhibitor|OTHER: No simvastatin|DRUG: Simvastatin|DRUG: Eritoran|DRUG: Apremilast|PROCEDURE: Clinician-preferred mechanical ventilation strategy|PROCEDURE: Protocolised mechanical ventilation strategy|OTHER: No renin-angiotensin system inhibitor|DRUG: Angiotensin converting enzyme inhibitor|DRUG: Angiotensin Receptor Blockers|DRUG: ARB + DMX-200|OTHER: No cysteamine|DRUG: Cysteamine|DRUG: Fixed-duration dexamethasone|DRUG: Baloxavir Marboxil|DRUG: Five-days oseltamivir + baloxavir marboxil|DRUG: Ten-days oseltamivir + baloxavir marboxil|OTHER: No endothelial modulator|DRUG: Imatinib|OTHER: No Immune Modulator for Influenza|DRUG: Tocilizumab|DRUG: Baricitinib|OTHER: No antiviral agent for COVID-19|DRUG: Nirmatrelvir/ritonavir|DRUG: Remdesivir|DRUG: Nirmatrelvir/ritonavir + remdesivir
Sponsor Sponsor: UMC Utrecht - Collaborators: Australian and New Zealand Intensive Care Research Centre|Medical Research Institute of New Zealand|Unity Health|Berry Consultants|Global Coalition for Adaptive Research|University of Pittsburgh Medical Center|Intensive Care National Audit & Research Centre|St. Marianna University School of Medicine|Nat Intensive Care Surveillance - MORU|National University Hospital, Singapore
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 20000
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 04/11/2016
Completion Date 02/01/2028
Locations Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy
Study URL https://clinicaltrials.gov/study/NCT02735707 

 

Study Title A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
NCT Number NCT03900429
Conditions NASH - Nonalcoholic Steatohepatitis
Interventions DRUG: MGL-3196|DRUG: Placebo
Sponsor Madrigal Pharmaceuticals, Inc.
Gender  
Age  
Phases PHASE3
Enrollment 1759
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 28/03/2019
Completion Date 01/01/2028
Locations Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, Italy|  Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT), Palermo, Italy|
URL https://clinicaltrials.gov/study/NCT03900429 

 

Study Title Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)
NCT Number NCT06347315 Other IDs: 2302.CLI
Conditions Mild Cognitive Impairment
Interventions DIETARY_SUPPLEMENT: BrainXpert|OTHER: Placebo
Sponsor Société des Produits Nestlé (SPN)
Sex ALL
Age ADULT, OLDER_ADULT
Phases NA
Enrollment 380
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date 24/05/2024
Completion Date 15/12/2027
Locations Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT06347315 

 

Title Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study
NCT Number NCT05049798
Conditions Arthritis, Psoriatic
Interventions Drug: Guselkumab
Drug: IL-17i
Sponsor Janssen Pharmaceutica N.V., Belgium
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 1300 participants
Study Type Observational
Study Designs Cohort
Start Date 25/08/2021
Completion Date 07/12/2027
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Dermatologia, Prof.ssa Maria Rita Bongiorno
URL https://www.clinicaltrials.gov/ct2/show/NCT05049798 

  

Title A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients
Studio di fase 3, randomizzato, in doppio cieco, con controllo attivo di CPI-0610 e Ruxolitinib rispetto a placebo e Ruxolitinib nei pazienti con MF naïve al trattamento con JAKi
EudraCT number

2020-001989-10
MANIFEST-2

CPI 0610-04

NCT04603495

Conditions Myelofibrosis

Mielofibrosi
Interventions  
Sponsor Name Constellation Pharmaceuticals, Inc.
Gender Female; Male
Age Adults; Elderly; 
Phases Phase III
Enrollment 310
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled; Randomised; Parallel group; Il crossover è possibile per il braccio di controllo dopo il trattamento in doppio cieco

Crossover is possible for control arm after double-blind treatment
Start Date 02/11/2021
Completion Date 01/12/2027
Locations United States - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott. Marco Santoro
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001989-10/IT 

 

Title

The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular disease

Sicurezza cardiovascolare di cagrilintide 2,4 mg in combinazione con semaglutide 2,4 mg (CagriSema 2,4 mg/2,4 mg) da assumere per via sottocutanea una volta alla settimana in partecipanti con obesità e malattia cardiovascolare accertata

EudraCT number 2021-005855-35
Conditions Atherosclerotic cardiovascular disease and Obesity
Malattia cardiovascolare aterosclerotica e obesità
Interventions  
Sponsor NOVO NORDISK. S.P.A.
Gender Female; Male
Age Adults; Elderly; 
Phases Phase III
Enrollment 4000
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled; Randomised; Parallel group; 
Start Date 01/10/2023
Completion Date 29/11/2027
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005855-35/IT 

 

Title A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes
NCT Number NCT05433584
17205
I8F-MC-GPHE ( Other Identifier ) (OTHER: Eli Lilly and Company)
2022-000130-42 ( EudraCT Number )
2022-5010733-40-00 ( Other Identifier ) (OTHER: EU Trial Number)
U1111-1282-0263 ( Registry Identifier ) (REGISTRY: World Health Organization)
Conditions Type 2 Diabetes
Interventions Drug: Tirzepatide
Drug: Antihyperglycemic medication
Sponsor Eli Lilly and Company
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 4
Enrollment 780 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 01/08/2022
Completion Date 29/11/2027
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Malattie Endocrine, del Ricambio e della Nutrizione, prof.ssa Carla Giordano
URL https://www.clinicaltrials.gov/ct2/show/NCT05433584 

 

Study Title REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
NCT Number NCT05669755 Other IDs: NN9838-4942|U1111-1270-0943|2021-005855-35|jRCT2031220672
Conditions Cardiovascular Disease
Interventions DRUG: Cagrilintide|DRUG: Semaglutide|DRUG: Placebo
Sponsor Novo Nordisk A/S
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 7000
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 03/01/2023
Completion Date 13/10/2027
Locations prof. Silvio Buscemi, Unità funzionale di Nutrizione Clinica, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT05669755 

 

Title A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity
NCT Number NCT05556512
Conditions Obesity
Overweight
Interventions Drug: Tirzepatide
Drug: Placebo
Sponsor Eli Lilly and Company
Gender All
Age 40 Years and older (Adult, Older Adult)
Phases Phase 3
Enrollment 15000 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 11/10/2022
Completion Date 07/10/2027
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Nutrizione Clinica, Obesità e Metabolismo, prof. Silvio Buscemi
URL https://www.clinicaltrials.gov/ct2/show/NCT05556512 

 

Study Title A Study of Guselkumab in Participants With Active Psoriatic Arthritis
NCT Number NCT04882098
Conditions Arthritis, Psoriatic
Interventions DRUG: Guselkumab|DRUG: Placebo
Sponsor Janssen Research & Development, LLC
Gender  
Age  
Phases PHASE3
Enrollment 950
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 17/06/2021
Completion Date 12/08/2027
Locations Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy|
URL https://clinicaltrials.gov/study/NCT04882098 

 

Title Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, and the Role of Glasdegib as a Post-transplant Maintenance, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML
NCT Number NCT04168502
AML1819
Conditions  
Interventions Parallel Assignment
Sponsor  
Gender All
Age 18 Years to 60 Years (Adult)
Phases III
Enrollment 414 participants
Study Type Interventional (Clinical Trial)
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Start Date 24/09/2020
Completion Date 01/04/2027
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra
URL https://clinicaltrials.gov/ct2/show/NCT04168502 

 

Study Title Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
NCT Number NCT06506084 Other IDs: ROPEG-PV
Conditions Polycythemia Vera
Interventions DRUG: Ropeginterferon alfa-2b
Sponsor FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 319
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 09/08/2022
Completion Date 31/12/2026
Locations Azienda Ospedaliera Universitaria Policlinico "P. Giaccone", Divisione di Ematologia, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT06506084 

 

Study Title Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
NCT Number NCT04267393
Conditions Nonalcoholic Steatohepatitis (NASH)
Interventions DRUG: BMS-986263|OTHER: Placebo
Sponsor Bristol-Myers Squibb
Gender  
Age  
Phases PHASE2
Enrollment 124
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 17/03/2021
Completion Date 28/12/2026
Locations A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic, Palermo, 90127, Italy|
URL https://clinicaltrials.gov/study/NCT04267393 

 

Title A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
NCT Number NCT05581303
AMG 20180244
Conditions Atherosclerotic Cardiovascular Disease
Interventions Parallel Assignment
Sponsor Amgen
Gender All
Age 18 Years to 85 Years   (Adult, Older Adult)
Phases Phase 3
Enrollment 6000 participants
Study Type Interventional  (Clinical Trial)
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Start Date 14/12/2022
Completion Date 16/12/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof. Angelo Baldassare Cefalù, Principal Investigator
URL https://clinicaltrials.gov/ct2/show/NCT05581303 
https://www.amgentrials.com/study/?id=20180244 

 

Title Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double- Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies
NCT Number 2021-005092-39 (EudraCT)
Conditions atherosclerotic cardiovascular disease (ASCVD)
Interventions  
Sponsor NewAmsterdam Pharma B.V.
Gender All
Age 18 years of age at Screening (Visit 1)
Phases Phase 3
Enrollment 9000 participants
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled
Randomised
Double blind
Start Date 12/04/2022
Completion Date 07/12/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof. Angelo Baldassare Cefalù, Principal Investigator
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005092-39/IT 

 

Title Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
NCT Number NCT04867915
CLL2121
Conditions Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type
Interventions  
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 12500 participants
Study Type Observational
Study Designs Case-Only
Start Date 13/10/2021
Completion Date 31/10/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04867915 

 

Title Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes (EQoL-MDS)
NCT Number NCT02912208
Conditions Myelodysplastic Syndromes

Thrombocytopenia
Interventions  
Sponsor Associazione Qol-one
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 2
Enrollment 174 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 11/06/2011
Completion Date 31/10/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT02912208 

 

Title Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY): A GIMEMA Observational Registry for Italian MPN Patients
NCT Number NCT04378855
QoL MPN0118
Conditions Myeloproliferative Neoplasm
Other: Questionnaire
Interventions  
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases Phase 2
Enrollment 576 participants
Study Type Observational
Study Designs Cohort
Start Date 30/09/2020
Completion Date 31/10/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04378855 

 

Title Prospective Observational Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
NCT Number NCT05548062
CINC424BIT01
Conditions Polycythemia Vera
Interventions Other: Hydroxyurea
Other: Ruxolitinib
Sponsor Novartis ( Novartis Pharmaceuticals )
Gender All
Age 18 Years to 99 Years   (Adult, Older Adult)
Phases  
Enrollment 300 participants
Study Type Observational
Study Designs Cohort
Start Date 02/03/2023
Completion Date 30/09/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT05548062 

 

Study Title A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NCT Number NCT04849728
Conditions NASH - Nonalcoholic Steatohepatitis
Interventions DRUG: IVA337|DRUG: Placebo
Sponsor Inventiva Pharma
Gender  
Age  
Phases PHASE3
Enrollment 1000
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 19/08/2021
Completion Date 30/09/2026
Locations Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy|
URL https://clinicaltrials.gov/study/NCT04849728 

 

Study Title Multidimensional Approach for COPD and High Complexity
NCT Number NCT04986332
Conditions Chronic Obstructive Pulmonary Disease|Heart Failure|Chronic Disease
Interventions BEHAVIORAL: Physical activity program|OTHER: Global therapeutic remodeling
Sponsor Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Gender  
Age  
Phases  
Enrollment 300
Study Type INTERVENTIONAL
Study Design Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 01/09/2021
Completion Date 01/09/2026
Locations prof. Domenico Di Raimondo, Palermo, 90127, Italy
URL https://clinicaltrials.gov/study/NCT04986332 

 

Study Title A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Adult Participants With Fabry Disease
NCT Number NCT05206773
Conditions Fabry Disease
Interventions DRUG: Venglustat (GZ402671)|DRUG: Placebo
Sponsor Genzyme, a Sanofi Company
Gender  
Age  
Phases PHASE3
Enrollment 114
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 03/11/2022
Completion Date 07/08/2026
Locations Azienda Ospedaliera Universitaria_Investigational Site Number: 3800003, Palermo, 90127, Italy|
URL https://clinicaltrials.gov/study/NCT05206773 

 

Title A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 versus Best Available Therapy in Subjects with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Count <50,000/µL)

Studio di Fase 2b, in aperto, multicentrico, randomizzato, controllato, a 2 bracci per valutare l’efficacia e la sicurezza di NS-018 somministrato per via orale rispetto alla migliore terapia disponibile in soggetti con mielofibrosi primaria, mielofibrosi post-policitemia vera o mielofibrosi post-trombocitemia essenziale con trombocitopenia grave (conta piastrinica <50.000/µl)
EudraCT number 2021-000369-34
NS-018-201
Medical condition Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia

Mielofibrosi primaria, mielofibrosi post-policitemia vera o mielofibrosi posttrombocitemia essenziale con grave trombocitopenia
Interventions  
Sponsor/Collaborators NS Pharma, Inc, IQVIA Biotech
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 120
Trial type Therapeutic exploratory (Phase II)
Design of the trial Controlled; Randomised; Open; 
Start Date 02/07/2023
Completion Date 01/07/2026
Locations A.O.U. Policlinico P. Giaccone Palermo, Prof. Sergio Siragusa U.O.C. di Ematologia
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000369-34/IT 

 

Title Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients
NCT Number NCT05616871
P22-897
Conditions Psoriatic Arthritis
Interventions  
Sponsor AbbVie
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 450 participants
Study Type Observational
Study Designs Cohort
Start Date 15/12/2022
Completion Date 14/06/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof.ssa Giuliana Guggino, U.O.C. di Reumatologia
URL https://www.clinicaltrials.gov/ct2/show/NCT05616871 

 

Title Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 2)

Studio di Fase 3, multicentrico, randomizzato, in doppio cieco, per valutare l’efficacia e la sicurezza del trattamento con bepirovirsen in partecipanti con infezione cronica da virus dell’epatite B negativi per HBeAg trattati con analoghi nucleosidici o nucleotidici (B-Well 2).
EudraCT number 2022-002268-53
Medical condition Chronic Hepatitis B infection

Infezione cronica da Epatite B
Interventions  
Sponsor/Collaborators GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 534
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; 
Start Date 28/11/2022
Completion Date 27/03/2026
Locations United Kingdom - A.O.U. Policlinico P. Giaccone Palermo, DI MARCO VITO
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002268-53/IT 

 

Title A Phase 2, prospective, multi-center intervention trial in patients with acute myeloid leukemia secondary to myeloproliferative neoplasms unfit for intensive chemotherapy investigating a treatment combination including decitabine and venetoclax.
ENABLE (vENetoclax plus decitAbine treatment in Blastic phase of myeLoproliferative nEoplasms)

Studio interventistico di fase II, prospettico, multicentrico, in pazienti affetti da leucemia mieloide acuta secondaria a neoplasie mieloproliferative non eleggibili per chemioterapia intensiva, per valutare una terapia di combinazione con decitabina e venetoclax.
EudraCT number 2020-006114-20
AML2420; ENABLE
Conditions Acute Myeloid Leukemia secondary to myeloproliferative neoplasms
Leucemia Mieloide Acuta secondaria a neoplasie mieloproliferative
Interventions  
Sponsor Name FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender Female; Male
Age Adults; Elderly; 
Phases Phase II
Enrollment 101
Study Type Therapeutic exploratory (Phase II)
Study Designs Controlled; Open; 
Start Date 17/09/2021
Completion Date 15/03/2026
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006114-20/IT 

 

Title An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib

Studio di fase 1b/2 in aperto, multicentrico per valutare la sicurezza e l’efficacia di KRT-232 in combinazione con ruxolitinib in pazienti con mielofibrosi primaria (PMF), MF post-policitemia vera (Post-PV-MF) o MF post-trombocitemia essenziale (Post-ET-MF) che rispondono a ruxolitinib in maniera subottimale
EudraCT number 2019-004554-29
NCT04485260
KRT-232-109
Conditions Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF)

Mielofibrosi primaria (PMF), Post – Policitemia Vera MF (Post – PV-MF) o Trombocitemia post-essenziale MF (Post-ET-MF)
Interventions  
Sponsor Name Kartos Therapeutics, Inc
Gender Female; Male
Age Adults; Elderly; 
Phases Phase II
Enrollment 78
Study Type Therapeutic exploratory (Phase II)
Study Designs Sicurezza ed efficacia di KRT-232 con Ruxolitinib nei pazienti con PMF, Post – PV-MF, Post-ET-MF
Safety and Efficacy of KRT-232 with Ruxolitinib in Patients with PMF, Post–PV-MF, Post-ET-MF
Start Date 11/03/2020
Completion Date 10/03/2026
Locations United States
Italy: A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004554-29/IT
https://www.clinicaltrials.gov/ct2/show/NCT04485260 

 

Study Title Functional Assessment in Elderly MI Patients With Multivessel Disease
NCT Number NCT03772743 Other IDs: 56/2019/Sper/AOUFe
Conditions Myocardial Infarction
Interventions OTHER: Culprit-only revascularization|OTHER: Complete functionally-guided revascularization
Sponsor Consorzio Futuro in Ricerca
Sex ALL
Age OLDER_ADULT
Phases NA
Enrollment 1445
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 15/07/2019
Completion Date 10/03/2026
Locations prof. A.R. Galassi, AOU Giaccone, Palermo, Italy
Study URL https://clinicaltrials.gov/study/NCT03772743 

 

Study Title A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
NCT Number NCT05877547 Other IDs: 6024-013|2022-502647-35-00|MK-6024-013|jRCT2031230187
Conditions Non-alcoholic Fatty Liver Disease|Fatty Liver, Nonalcoholic|NAFLD|Nonalcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis
Interventions DRUG: Efinopegdutide|DRUG: Semaglutide|DRUG: Placebo
Sponsor Merck Sharp & Dohme LLC
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 300
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 23/06/2023
Completion Date 13/02/2026
Locations A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402), Palermo, Sicilia, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT05877547 

 

Study Title A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
NCT Number NCT06077864 Other IDs: 1404-0040|2022-502442-27-00|U1111-1289-0174
Conditions Obesity
Interventions DRUG: survodutide|DRUG: Placebo
Sponsor Boehringer Ingelheim
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 4935
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 17/11/2023
Completion Date 04/02/2026
Locations A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT06077864 

 

Study Title A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
NCT Number NCT06065540 Other IDs: NN9388-4896|U1111-1283-0427|2022-502678-18
Conditions Type 2 Diabetes Mellitus
Interventions DRUG: Cagrilintide|DRUG: Semaglutide|DRUG: Placebo cagrilintide|DRUG: Placebo semaglutide
Sponsor Novo Nordisk A/S
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 2700
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 27/09/2023
Completion Date 14/01/2026
Locations AOUP Giaccone Palermo, Palermo, 90127, Italy| Dip. di Medicina Interna Policlinico Universitario Palermo, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT06065540 

 

Study Title Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
NCT Number NCT05202509
Other IDs: TA-8995-304
Conditions Atherosclerotic Cardiovascular Disease
Interventions DRUG: Obicetrapib|DRUG: Placebo
Sponsor NewAmsterdam Pharma
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 9000
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 02/07/2022
Completion Date 12/01/2026
Locations Prof. Giuseppina Novo, Cardiologia, Centro per la Diagnosi Precoce di Aterosclerosi Preclinica e Pluridistrettuale  per la Prevenzione Secondaria, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy
Study URL https://clinicaltrials.gov/study/NCT05202509 

  

Study Title Multidimensional Approach for COPD and High Complexity
NCT Number NCT04986332 Other IDs: MACH Study
Conditions Chronic Obstructive Pulmonary Disease|Heart Failure|Chronic Disease
Interventions BEHAVIORAL: Physical activity program|OTHER: Global therapeutic remodeling
Sponsor Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Sex ALL
Age ADULT, OLDER_ADULT
Phases NA
Enrollment 300
Study Type INTERVENTIONAL
Study Design Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 09/01/2021
Completion Date 09/01/2026
Locations Domenico Di Raimondo, Palermo, 90127, Italy
Study URL https://clinicaltrials.gov/study/NCT04986332 

 

Title A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)
EudraCT number 2022-002695-37
NCT05627362
CLIN-60190-453
Conditions Adults patients with Primary Sclerosing Cholangitis (PSC)
Pacientes adultos con colangitis esclerosante primaria (CEP)
Interventions  
Sponsor Ipsen Bioscience, Inc.
Gender Female; Male
Age Adults; Elderly; 
Phases Phase II
Enrollment 61
Study Type Therapeutic exploratory (Phase II)
Study Designs Controlled; Randomised; Parallel group; 
Start Date 13/02/2023
Completion Date 08/01/2026
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo, UOC di Gastroenterologia, Prof.ssa Vincenza Calvaruso
URL https://www.clinicaltrials.gov/ct2/show/NCT05627362 
https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002695-37/ES 

 

Study Title A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis
NCT Number NCT05785611 Other IDs: GLPG0634-CL-336|2022-501354-10-01
Conditions Axial Spondyloarthritis
Interventions DRUG: Filgotinib|DRUG: Placebo
Sponsor Galapagos NV
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 495
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 04/05/2023
Completion Date 07/01/2026
Locations Prof.ssa Giuliana Guggino, Reumatologia, Policlinico Paolo Giaccone, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT05785611 

 

Study Title A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
NCT Number NCT06412250 Other IDs: TL/SECURE/VIVO/2023-01
Conditions Cardiovascular Diseases
Interventions  
Sponsor Sponsor: Translumina Therapeutics LLP - Collaborators: Iqvia Pty Ltd
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 2000
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 01/10/2024
Completion Date 05/01/2026
Locations Dr. Salvatore Evola, Prof.ssa GIUSEPPINA NOVO, Cardiologia, Aoup Paolo Giaccone, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT06412250 

 

Study Title A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
NCT Number NCT04628481
Other IDs: LDX0319|2020-001926-71
Conditions New-onset type1 Diabetes
Interventions DRUG: Ladarixin|DRUG: Placebo
Sponsor Dompé Farmaceutici S.p.A
Sex ALL
Age CHILD, ADULT
Phases PHASE3
Enrollment 327
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 21/12/2020
Completion Date 03/01/2026
Locations prof.ssa Carla Giordano, U.O. Malattie Endocrine, del Ricambio e della Nutrizione, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04628481 

 

Study Title Oxygen-ozone Therapy Plus Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices
NCT Number NCT04787575 Other IDs: sOO3T1 Study
Conditions Infection
Interventions PROCEDURE: Oxygen-ozone therapy
Sponsor Società Scientifica Internazionale di Ossigeno Ozono Terapia
Sex ALL
Age ADULT, OLDER_ADULT
Phases NA
Enrollment 186
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 24/01/2024
Completion Date 01/01/2026
Locations Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone di Palermo, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT04787575 

 

Title An 18-month Low-interventional Prospective, Multicentre Study to Assess Joint Outcomes in Patients With Haemophilia A or B on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
NCT Number NCT05856266
Conditions Hemophilia A
Hemophilia B
Interventions Procedure: Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US)
Other: Haemophilia Joint Health Score (HJHS)
Sponsor Swedish Orphan Biovitrum
Gender All
Age 6 Years and older   (Child, Adult, Older Adult)
Phases Phase 4
Enrollment 250 participants
Study Type Interventional  (Clinical Trial)
Study Designs Single Group Assignment
Start Date 24/07/2023
Completion Date 01/01/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Ematologia, prof.ssa Mariasanta Napolitano
URL https://www.clinicaltrials.gov/ct2/show/NCT05856266 

 

Title HoFH, the International Clinical Collaborators - A Global HoFH Data-sharing Platform
NCT Number NCT04815005
HICC
Conditions Homozygous Familial Hypercholesterolemia
Interventions Parallel Assignment
Sponsor University of Pennsylvania
Gender All
Age Child, Adult, Older Adult
Phases  
Enrollment 1000 participants
Study Type Observational [Patient Registry]
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Start Date 24/01/2017
Completion Date 31/12/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof. Maurizio Averna, Prof. Angelo Baldassare Cefalù
URL https://clinicaltrials.gov/ct2/show/NCT04815005
https://www.centerwatch.com/clinical-trials/listings/270143/hofh-the-international-clinical-collaborators-registry/   

 

Title A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)

Studio controllato con placebo di fase 3, multicentrico, randomizzato, in quadruplo cieco di batoclimab per il trattamento di partecipanti affetti da oftalmopatia tiroidea (TED) attiva
EudraCT number 2022-002787-68
Medical condition Thyroid Eye Disease (TED)

Oftalmopatia tiroidea (TED) attiva
Interventions  
Sponsor/Collaborators Immunovant Sciences GmbH
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 100
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; 
Start Date 02/10/2023
Completion Date 30/12/2025
Locations Switzerland - A.O.U. Policlinico P. Giaccone Palermo, GUARNOTTA VALENTINA
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002787-68/IT 

 

Title A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
NCT Number NCT05079919 - (EudraCT Number: 2021-002192-19)
Conditions Severe Hypertriglyceridemia
Interventions Drug: Olezarsen
Drug: Placebo
Sponsor Ionis Pharmaceuticals, Inc.
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases Phase 3
Enrollment 540
Study Type Interventional
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Start Date 25/10/2021
Completion Date 13/12/2025
Locations Italy
Ospdale E. Bassini - Milano, Italy, 20092
A.O. Policlinico Universitario P. Giaccone - Palermo, Italy, 90127
Policlinico Umberto - Roma, Italy, 00161 
and other 94 international study locations
URL https://ClinicalTrials.gov/show/NCT05079919 

  

Title ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
NCT Number NCT03301506
CB8025-31731
Prot. Cb8025-31731-Re ­
Codice Eudract: 2020-005198-29
Conditions  
Interventions Parallel Assignment
Sponsor CymaBay Therapeutics, Inc.
Gender All
Age 18 Years to 75 Years   (Adult, Older Adult)
Phases  
Enrollment 500 participants
Study Type Interventional
                 (Clinical Trial)
Study Designs Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Start Date 12/12/2017
Completion Date 01/12/2025
Locations Sperimentatore: Prof.ssa V. Calvaruso;
Centro: U.O.C. di Gastroenterologia ed Epatologia A.O.U. Policlinico P. Giaccone di Palermo;
Promotore: CymaBay Therapeutics, Inc.
CRO: PPD Italy s.r.l.
URL https://clinicaltrials.gov/ct2/show/NCT03301506 

 

Title Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity. A Clinical Study and a Search for Diagnostic Biomarkers.
NCT Number NCT06191432
Conditions Non-celiac Gluten Sensitivity
Interventions Dietary Supplement: Administration of Triticum Monococcum flour
Dietary Supplement: Administration of Triticum Aestivum flour
Sponsor/Collaborators Pasquale Mansueto, University of Palermo
Gender All
Age 18 Years to 65 Years   (Adult, Older Adult)
Phases  
Enrollment 68 participants
Study Type Interventional  (Clinical Trial)
Study Designs Crossover Assignment
Start Date 05/01/2024
Completion Date 30/11/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, Pasquale Mansueto, Antonio Carroccio
URL https://www.clinicaltrials.gov/ct2/show/NCT06191432 

 

Title A Randomised, Double-blind, Placebo-Controlled, Multi-Center Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele

Studio di fase IIb randomizzato, multicentrico, in doppio cieco, controllato con placebo volto a valutare l’efficacia, la sicurezza e la tollerabilità di AZD2693 in pazienti affetti da steatoepatite non alcolica non cirrotica (NASH) con fibrosi e portatori dell’allele di rischio di PNPLA3 rs738409 148M
EudraCT number 2022-001629-65
D7830C00004
Medical condition Non-cirrhotic non-alcoholic steatohepatitis with fibrosis

Steatoepatite non alcolica non cirrotica con fibrosi
Interventions  
Sponsor/Collaborators ASTRAZENECA AB
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 318
Trial type Therapeutic exploratory (Phase II)
Design of the trial Controlled; Randomised; Parallel group; 
Start Date 13/03/2023
Completion Date 08/10/2025
Locations A.O.U. Policlinico P. Giaccone Palermo, Prof. Salvatore Petta, U.O.C. di Gastroenterologia
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-001629-65/IT 

 

Title A Phase 3, prospective, randomized multi-center intervention trial of early intensification in AML patients bearing FLT3 mutations based on peripheral blast clearance. A MYNERVA-GIMEMA study.
AMELIORATE (AML Early IntensificatiOn based on peRipheral blAsT clEarance)
EudraCT Number 2019-003936-21
AML1919/AMELIORATE
Conditions Acute Myeloid Leukemia (LMA) with FLT3 mutation
Interventions  
Sponsor Name FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender All
Age Adults, Elderly
Phases III
Enrollment 172
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled, Randomised, Open, Parallel group, Comparison of standard therapy vs. experimental therapeutic approach
Start Date 09/04/2020
Completion Date 05/10/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003936-21/IT 

 

Title ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation

ZEUS - Effetti di ziltivekimab versus placebo sugli esiti cardiovascolari in soggetti con malattia cardiovascolare aterosclerotica accertata, patologia renale cronica e infiammazione sistemica
EudraCT number

2020-004853-59

EX6018-4758

Medical condition Atherosclerotic cardiovascular disease

Chronic kidney disease

Systemic inflammation

Malattia cardiovascolare aterosclerotica

Malattia renale cronica

Infiammazione sistemica
Interventions  
Sponsor/Collaborators NOVO NORDISK. S.P.A.
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 6200
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Parallel group; 
Start Date 20/08/2021
Completion Date 18/09/2025
Locations Denmark - A.O.U. Policlinico P. Giaccone Palermo, TUTTOLOMONDO ANTONINO
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004853-59/IT 

 

Title TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib With a 52-week Extension Phase in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
NCT Number NCT05014672
GSN000350
2021-001810-13 ( EudraCT Number )
Conditions Primary Biliary Cholangitis
Liver Stiffness
Interventions Parallel Assignment
Sponsor Calliditas Therapeutics Suisse SA
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 2
Phase 3
Enrollment 318 participants
Study Type Interventional
 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Intervention Model Description: Placebo-controlled 1:1:1 in double blind treatment period with 1:1 reassignment to setanaxib in extension period | Masking: Double (Participant, Investigator)
Start Date 14/02/2022
Completion Date 15/09/2025
Locations Sperimentatore: Dott.ssa V. Calvaruso Centro: U.O.C. di Gastroenterologia Promotore: Genkyotex Suisse SA CRO: Pharmaceutical Research Associates Italy S.r.l.
URL https://clinicaltrials.gov/ct2/show/NCT05014672 

 

Title An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)

Studio di estensione in aperto per partecipanti che hanno completato lo studio IMVT-1401-3201 o lo studio IMVT-1401-3202 per valutare l’efficacia e la sicurezza di batoclimab per il trattamento dell’oftalmopatia tiroidea (TED)
EudraCT number 2022-002839-66
Medical condition Thyroid Eye Disease (TED)

Oftalmopatia tiroidea (TED)
Interventions  
Sponsor/Collaborators Immunovant Sciences GmbH
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 180
Trial type Therapeutic confirmatory (Phase III)
Design of the trial  
Start Date 23/02/2023
Completion Date 22/07/2025
Locations Switzerland - A.O.U. Policlinico P. Giaccone Palermo, GUARNOTTA VALENTINA
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002839-66/IT 

 

Title A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia
NCT Number NCT05610280
ISIS 678354-CS9
2022-501486-53 ( EudraCT Number )
Conditions Hypertriglyceridemia
Cardiovascular Diseases
Atherosclerosis
Interventions Drug: Olezarsen
Drug: Placebo
Sponsor Ionis Pharmaceuticals, Inc.
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 1312 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 21/11/2022
Completion Date 01/06/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Astanteria/MCAU, prof. Angelo Baldassare Cefalù
URL https://www.clinicaltrials.gov/ct2/show/NCT05610280 

 

Title A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet
NCT Number NCT05353985
TAK-062-2001
2020-005438-14 ( EudraCT Number )
Conditions Celiac Disease
Interventions Drug: TAK-062
Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar
Drug: TAK-062 Placebo
Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
Sponsor Takeda
Gender All
Age 12 Years and older   (Child, Adult, Older Adult)
Phases Phase 2
Enrollment 377 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 30/06/2022
Completion Date 06/05/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Geriatria, prof. Pasquale Mansueto
URL https://www.clinicaltrials.gov/ct2/show/NCT05353985 

 

Title An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® (Avatrombopag) in Adult Patients With Immune Thrombocytopenia (ITP)
NCT Number NCT04943042
Sobi.Doptelet-001
Conditions Intervention/treatment 
Immune Thrombocytopenia
ITP
Interventions Drug: Avatrombopag
Sponsor/Collaborators Swedish Orphan Biovitrum - CRO: Syneos Health Italy S.r.l. 
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 150 participants
Study Type Observational
Study Designs Cohort
Start Date 22/02/2022
Completion Date 01/05/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof.ssa Mariasanta Napolitano, U.O.C. di Ematologia
URL https://www.clinicaltrials.gov/ct2/show/NCT04943042 

 

Title An Open-Label Extension Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
NCT Number NCT05130450 - (EudraCT Number: 2021-003280-95)
Conditions Familial Chylomicronemia Syndrome
Interventions Drug: Olezarsen
Sponsor Ionis Pharmaceuticals, Inc.
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases Phase 3
Enrollment 60
Study Type Interventional
Study Designs Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Start Date 18/11/2021
Completion Date 30/04/2025
Locations Italy
UOC di Farmacia AOUP PAOLO GIACCONE - Palermo, Italy, 90127 
Prof. Angelo Baldassare Cefalù, Principal Investigator 
and other 11 international study locations
URL https://ClinicalTrials.gov/show/NCT04568434 

 

Title 17 beta-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with Pre-Cirrhotic Non-Alcoholic

Steatohepatitis

Studio in doppio cieco, controllato verso placebo, di Fase 2b per valutare l’efficacia e la sicurezza di GSK4532990 in adulti con steatoepatite pre-cirrotica non alcolica (Non-Alcoholic Steatohepatitis – NASH)
EudraCT number 2022-002538-14
218672
Medical condition Nonalcoholic steatohepatitis (NASH)

Steatoepatite pre-cirrotica non alcolica (NASH)
Interventions  
Sponsor/Collaborators GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 246
Trial type Therapeutic exploratory (Phase II)
Design of the trial Controlled; Randomised; Parallel group; 
Start Date 27/01/2023
Completion Date 25/02/2025
Locations A.O.U. Policlinico P. Giaccone Palermo, Prof. Salvatore Petta, U.O.C. di Gastroenterologia
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002538-14/IT 

 

Study Title Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)
NCT Number NCT06122961 Other IDs: NN6018-7527|U1111-1286-3420
Conditions Cardiovascular Risk|Heart Failure|Chronic Kidney Disease
Interventions OTHER: No treatment given
Sponsor Novo Nordisk A/S
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 21504
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 23/11/2023
Completion Date 17/02/2025
Locations A.O.U. Policlinico Giaccone, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT06122961 

 

Title Non-Interventional Study of the Change in Joint Health in Adult Patients With Haemophilia A After Switching to Prophylaxis With Turoctocog Alfa Pegol (N8-GP)
NCT Number NCT05621746
NN7088-4928
Conditions Intervention/treatment 

Haemophilia A

Drug: Esperoct
Interventions  
Sponsor Novo Nordisk A/S
Gender Male
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 100 participants
Study Type Observational
Study Designs Cohort
Start Date 23/11/2022
Completion Date 14/02/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Ematologia, prof.ssa Mariasanta Napolitano
URL https://www.clinicaltrials.gov/ct2/show/NCT05621746 

 

Title Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy: An Observational Prospective Study Of The Fondazione Italiana Linfomi
NCT Number NCT05524298
FIL_QoL-ELDIND
Conditions Low Grade Non-Hodgkin's Lymphoma, Adult
Interventions  
Sponsor Fondazione Italiana Linfomi ONLUS
Gender All
Age 70 Years and older   (Older Adult)
Phases  
Enrollment 150 participants
Study Type Observational
Study Designs Cohort
Start Date 01/09/2022
Completion Date 01/02/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Dott.ssa Salvatrice Mancuso
URL https://www.clinicaltrials.gov/ct2/show/NCT05524298 

 

Title Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
NCT Number NCT04298892
Conditions Intervention/treatment 

Haematologic Disease

Haematological Malignancy

Other: clinical data and sample collection
Interventions  
Sponsor Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 2000 participants
Study Type Observational [Patient Registry]
Study Designs Cohort
Start Date 07/01/2020
Completion Date 01/02/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04298892 

 

Title A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)

Studio di Fase 2, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, a dosi multiple per valutare l’efficacia e la sicurezza di BMS-986263 in soggetti adulti con cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
EudraCT number 2019-003932-22
Medical condition Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)

Cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
Interventions  
Sponsor/Collaborators BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 270
Trial type Therapeutic exploratory (Phase II)
Design of the trial Controlled; Randomised; Parallel group; 
Start Date 26/04/2021
Completion Date 20/01/2025
Locations Belgium - A.O.U. Policlinico P. Giaccone Palermo, PETTA SALVATORE
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003932-22/IT

 

Study Title Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
NCT Number NCT05936580 Other IDs: GENA-23
Conditions Hemophilia A
Interventions DRUG: Nuwiq
Sponsor Octapharma
Sex FEMALE
Age CHILD, ADULT, OLDER_ADULT
Phases PHASE4
Enrollment 28
Study Type INTERVENTIONAL
Study Design Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date 08/01/2024
Completion Date 12/01/2025
Locations Policlinico "P. Giaccone", Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT05936580 

 

Study Title A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT Number NCT04442022 Other IDs: XPORT-DLBCL-030|2020-000605-84
Conditions Relapsed/Refractory Diffuse Large B-cell Lymphoma
Interventions DRUG: Selinexor (combination therapy)|DRUG: Selinexor (combination therapy)|DRUG: Selinexor (combination therapy)|DRUG: Placebo matching for Selinexor (combination therapy)|DRUG: Rituximab (combination therapy)|DRUG: Rituximab (combination therapy)|DRUG: Gemcitabine (combination therapy)|DRUG: Dexamethasone (combination therapy)|DRUG: Cisplatin (combination therapy)|DRUG: Selinexor (continuous therapy)|DRUG: Placebo matching for Selinexor (continuous therapy)
Sponsor Karyopharm Therapeutics Inc
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2|PHASE3
Enrollment 501
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 09/03/2020
Completion Date 12/01/2025
Locations Ospedali Riuniti "Villa Sofia-Cervello", Palermo, Italy| U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone", Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT04442022 

 

Study Title Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
NCT Number NCT04579367
Other IDs: DSE-BMP-01-20-EU
Conditions Hypercholesterolemia|Mixed Dyslipidemia
Interventions DRUG: Bempedoic acid and/or its fixed-dose combination with ezetimibe
Sponsor Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 5000
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 15/01/2021
Completion Date 09/01/2025
Locations prof. Maurizio Averna, Medicina Interna e Dislipidemie Genetiche, Dir. Prof. Carlo Maria Barbagallo,  A.O.U. Policlinico "P. Giaccone", Palermo, 90127, Italy|  Casa di Cura Triolo Zancla Hospital, Palermo, 90133, Italy|
Study URL https://clinicaltrials.gov/study/NCT04579367 

 

Study Title AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance
NCT Number NCT04174612 Other IDs: AML1919
Conditions Acute Myeloid Leukemia With FLT3/ITD Mutation
Interventions DRUG: Cytarabine|DRUG: Daunorubicin|DRUG: Midostaurin|DRUG: Cytarabine HD
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 172
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 24/04/2020
Completion Date 08/01/2025
Locations Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo, Palermo, Italy| dott.ssa Maria Enza Mitra, Ematologia, Dir. Prof. Sergio Mario Siragusa, Aou Policlinico P. Giaccone - Palermo - Uo Ematologia, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT04174612 

  

Study Title Ofatumumab & Ibrutinib + Allogeneic Bone Marrow Transplant or Consolidation in High Risk Chronic Lymphocytic Leukemia
NCT Number NCT02388048

Othr ID: LLC1215|2015-000684-13
Conditions Leukemia, Lymphoblastic, Chronic
Interventions DRUG: Ibrutinib + ofatumumab
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto - Collaborators:
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 19
Study Type INTERVENTIONAL
Study Design Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date 10/01/2015
Completion Date 08/01/2025
Locations U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone", Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT02388048 

 

Study Title A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
NCT Number NCT05595642 Other IDs: GB44332
Conditions Chronic Obstructive Pulmonary Disease (COPD)
Interventions DRUG: Astegolimab|DRUG: Placebo
Sponsor Hoffmann-La Roche
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 1290
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 29/12/2022
Completion Date 06/01/2025
Locations prof. Nicola Scichilone, U.O.C. di Pneumologia, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT05595642 

  

Title Potential Role of Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Ascites in Cirrhotic Patients
NCT Number NCT05999773
Conditions Intervention/treatment 

Ascites Hepatic

Cirrhosis, Liver

Diabete Type 2
Interventions Drug: SGLT2 inhibitor
Sponsor  
Gender All
Age 18 Years to 80 Years   (Adult, Older Adult)
Phases  
Enrollment 40 participants
Study Type Observational
Study Designs Case-Control
Start Date 15/06/2023
Completion Date 31/12/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, Lydia Giannitrapani,
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Aurelio Seidita
URL https://www.clinicaltrials.gov/ct2/show/NCT05999773 

 

Title Efficacy and Tolerability of a Composition Comprising of HMO in a Supplement Format on Colic Management: a Double-blind, Randomized, Placebo-controlled Trial
NCT Number NCT05554991
20.28.INF
Conditions Colic
Interventions Dietary Supplement: HMO
Dietary Supplement: Placebo
Behavioral: Parental reassurance and support
Sponsor Société des Produits Nestlé (SPN)
Gender All
Age 2 Weeks to 12 Weeks   (Child)
Phases  
Enrollment 144 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 24/06/2022
Completion Date 31/12/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Neonatologia e Nido, prof. Mario Giuffrè
URL https://www.clinicaltrials.gov/ct2/show/NCT05554991 

  

Title Impact of Extra Virgin Olive Oil (EVOO) With Health Properties in Improving the Overall Health Status and Preventing Cardiovascular Risk in Metabolic Syndrome
NCT Number NCT05282316
Conditions Metabolic Syndrome
Interventions Dietary Supplement: EVOO polyphenols enriched
Dietary Supplement: EVOO standard
Sponsor University of Palermo
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases Phase 3
Enrollment 90
Study Type Interventional
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Same organoleptic features of the two different kind of EVOO (polyphenols enriched and standard).
Primary Purpose: Prevention
Start Date 18/02/2022
Completion Date 31/12/2024
Locations Italy
Department of Internal Medicine, University Hospital of Palermo Recruiting
Palermo, Italy, 90127
Contact: Aurelio Seidita, MD +390916554710 aurelio.seidita@unipa.it
Contact: Maurizio Soresi, MD +390916554710 maurizio.soresi@unipa.it
Sub-Investigator: Lydia Giannitrapani, MD
URL https://ClinicalTrials.gov/show/NCT05282316  

 

Title A Multicentre, Prospective, Non-Interventional, Single-Arm Study Investigating Glycaemic Control and Patient-Reported Outcomes in Type 2 Diabetes Patients, Uncontrolled on DPP4i Treatment and Who Switch to Oral Semaglutide in a Real-World Setting in Italy
NCT Number NCT05755360
NN9924-7508
U1111-1274-4674 ( Other Identifier ) (OTHER: World Health Organization (WHO))
Conditions Intervention/treatment 

Diabetes Mellitus, Type 2

Drug: Semaglutide
Interventions  
Sponsor/Collaborators Novo Nordisk A/S
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 390 participants
Study Type Observational
Study Designs Cohort
Start Date 21/02/2023
Completion Date 31/10/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof. Mario Barbagallo, U.O.C. di Geriatria
URL https://www.clinicaltrials.gov/ct2/show/NCT05755360 

 

Study Title A Study to Test Whether Two Different Doses of BI 685509 Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
NCT Number NCT05161481
Other IDs: 1366-0021|2021-001285-38
Conditions Hypertension, Portal
Interventions DRUG: BI 685509|DRUG: Placebo matching BI 685509
Sponsor Boehringer Ingelheim
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 78
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 02/03/2022
Completion Date 24/10/2024
Locations prof.ssa Vincenza Calvaruso, , U.O.C. Gastroenterologia, A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT05161481 

 

Study Title A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
NCT Number NCT04255433
Other IDs: 17073|I8F-MC-GPGN|2019-002735-28
Conditions Type 2 Diabetes Mellitus
Interventions DRUG: Tirzepatide|DRUG: Dulaglutide
Sponsor Eli Lilly and Company
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 13299
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 29/05/2020
Completion Date 17/10/2024
Locations U.O.C. Malattie Endocrine, del Ricambio e della Nutrizione, prof.ssa Carla Giordano, A.O.U. Policlinico Paolo Giaccone, Palermo, Sicilia, 90129, Italy
Study URL https://clinicaltrials.gov/study/NCT04255433 

 

Study Title Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
NCT Number NCT04229901 Other IDs: HEP102
Conditions Acute on Chronic Liver Failure
Interventions DRUG: HepaStem|DRUG: Placebo
Sponsor Cellaion SA
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 133
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 21/01/2020
Completion Date 05/10/2024
Locations prof.ssa Vincenza Calvaruso, U.O.C. Gastroenterologia, Azienda Ospedaliera Universitaria Policlinico, Palermo, 90127, Italy
Study URL https://clinicaltrials.gov/study/NCT04229901 

 

Study Title A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
NCT Number NCT04166773 Other IDs: 17361|I8F-MC-GPHR|2019-001550-26
Conditions Nonalcoholic Steatohepatitis
Interventions DRUG: Tirzepatide|DRUG: Placebo
Sponsor Eli Lilly and Company
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 196
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 19/11/2019
Completion Date 01/10/2024
Locations Prof. Salvatore Petta, U.O.C. di Gastroenterologia, A.O.U. Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy
Study URL https://clinicaltrials.gov/study/NCT04166773 

 

Title An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis

Studio in aperto in pazienti adolescenti e adulti affetti da grave emofilia A o B (attività del fattore di coagulazione <1%) con o senza inibitori volto a confrontare la terapia standard con la profilassi con PF-06741086
EudraCT number 2018-003660-31
NCT03938792
Conditions Hemophilia A or B

Emofilia A o B
Interventions  
Sponsor PFIZER INC
Gender Male
Age Adolescents (12-17 years); Adults; Elderly; 
Phases Phase III
Enrollment 145
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled; Open; Unidirezionale

One way
Start Date 24/09/2020
Completion Date 27/09/2024
Locations United States - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003660-31/IT 
https://www.clinicaltrials.gov/ct2/show/NCT03938792

 

Study Title A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
NCT Number NCT04770896
Othr ID: MO42541
Conditions Unresectable Hepatocellular Carcinoma
Interventions DRUG: Atezolizumab|DRUG: Lenvatinib|DRUG: Sorafenib
Sponsor Hoffmann-La Roche - Collaborators:
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 554
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 26/04/2021
Completion Date 23/09/2024
Locations A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia, Palermo, Sicilia, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04770896 

 

Title The BASA Study: Breath Analysis for Severe Asthma Patients. A New, Non-invasive Approach for the Monitoring of Inflammation in Severe Asthma Patients on Biologics
NCT Number NCT05946421
Conditions Intervention/treatment 
Severe Asthma
Interventions Device: exhaled breath analysis
Sponsor  
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 100 participants
Study Type Observational
Study Designs Cohort
Start Date 04/07/2023
Completion Date 04/09/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, Nicola Scichilone, Stefania Principe, Carmen Durante
URL https://www.clinicaltrials.gov/ct2/show/NCT05946421 

 

Study Title A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
NCT Number NCT03819153 Other IDs: NN9535-4321|U1111-1217-6259|2018-002878-50|JapicCTI-194843
Conditions Diabetes Mellitus, Type 2
Interventions DRUG: Semaglutide|DRUG: Placebo (semaglutide)
Sponsor Novo Nordisk A/S
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 3508
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 17/06/2019
Completion Date 01/09/2024
Locations AOU Pol.Giaccone, U.O.C. Malattie Endocrine, del Ricambio e della Nutrizione, prof.ssa Carla Giordano, Palermo, PA, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT03819153 

 

Title Copanlisib in combination with Rituximab-Bendamustine in patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma: a multicentric Phase II trial

Copanlisib in combinazione con Rituximab e Bendamustina per il trattamento di pazienti con Linfoma Diffuso a Grandi Cellule B ricaduto o refrattario: studio multicentrico di fase II
EudraCT number 2019-004898-63
FIL COPA RB
Conditions Patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma

Pazienti con Linfoma Diffuso a Grandi Cellule B ricaduto o refrattario
Interventions  
Sponsor FONDAZIONE ITALIANA LINFOMI ONLUS
Gender Female; Male
Age Adults; Elderly; 
Phases Phase II
Enrollment 81
Study Type Therapeutic exploratory (Phase II)
Study Designs Studio di fase II, braccio singolo, in aperto
Phase II, single arm, open label clinical trial
Start Date 18/08/2020
Completion Date 17/08/2024
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott.ssa Salvatrice Mancuso
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004898-63/IT 

 

Title A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002)
NCT Number NCT03713593
MK 7902-002
Conditions Carcinoma, Hepatocellular
Interventions  
Sponsor Merck Sharp & Dohme LLC
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 3
Enrollment  
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 31/12/2018
Completion Date 29/08/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastro-enterologia, Prof. Antonio Craxì
URL https://www.clinicaltrials.gov/ct2/show/NCT03713593 

 

Title Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes
NCT Number NCT03914326
EX9924-4473

2018-003141-42 ( Registry Identifier: European Medicines Agency (EudraCT) )

U1111-1218-5368 ( Other Identifier: World Health Organization (WHO) )
Conditions Diabetes Mellitus, Type 2
Interventions Parallel Assignment
Sponsor Novo Nordisk A/S
Gender All
Age 50 Years and older   (Adult, Older Adult)
Phases Phase 3
Enrollment 9642 participants
Study Type Interventional
 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Start Date 17/06/2019
Completion Date 29/07/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo
URL https://clinicaltrials.gov/ct2/show/NCT03914326 

 

Title Efficacy of a Wheat-free Diet in Autoimmune Diseases: a Pilot Therapeutic Study in Sjogren's Disease
NCT Number NCT05644795
Conditions Sjogren's Syndrome
Non-celiac Gluten Sensitivity
Interventions Dietary Supplement: Wheat/milk free diet (W/MFD) group
Dietary Supplement: Rice/turkey free diet (R/TFD) group
Sponsor Pasquale Mansueto, University of Palermo
Gender All
Age 18 Years to 65 Years   (Adult, Older Adult)
Phases  
Enrollment 30
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 01/01/2023
Completion Date 30/06/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, Pasquale Mansueto, University of Palermo (Responsible Party)
URL https://www.clinicaltrials.gov/ct2/show/NCT05644795 

 

Study Title A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
NCT Number NCT05238675
Other IDs: 1397-0012|2021-003304-41
Conditions Bronchiectasis
Interventions DRUG: BI 1291583|DRUG: Placebo
Sponsor Boehringer Ingelheim
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 240
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 21/03/2022
Completion Date 13/06/2024
Locations Prof. Salvatore Battaglia, Pneumologia, Dir. Prof. Nicola Scichilone, A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT05238675 

 

Title Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects <= 75 Years of Age with Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia
EudraCT Number 2017-001600-29
Conditions Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia (AML)
Interventions  
Sponsor Name Arog Pharmaceuticals, Inc.
Gender Male, Female
Age Adults, Elderly
Phases III
Enrollment 322
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled; Randomised; Double blind; Parallel group
Start Date 13/06/2018
Completion Date 11/06/2024
Locations U.O.C. di Ematologia, AOUP P. Giaccone, Palermo, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-001600-29/IT 

 

Title A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
NCT Number NCT04886596
212494
2020-000753-28 ( EudraCT Number )
Conditions Respiratory Syncytial Virus Infections
Interventions Parallel Assignment
Sponsor GlaxoSmithKline
Gender All
Age 60 Years and older   (Adult, Older Adult)
Phases  
Enrollment 5000
Study Type Interventional (Clinical Trial)
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is an observer blind study.
Start Date 25/05/2021
Completion Date 31/05/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo
URL https://clinicaltrials.gov/ct2/show/NCT04886596 

 

Study Title Effect of AIRVO Heated Humidification in Bronchiectasis
NCT Number NCT04102774 Other IDs: AIRVO-BX
Conditions Bronchiectasis Adult
Interventions DEVICE: Over-night treatment with myAIRVO2
Sponsor Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico - Collaborators: Azienda Ospedaliera San Gerardo di Monza|ASST Fatebenefratelli Sacco|Fondazione IRCCS Policlinico San Matteo di Pavia|Ospedale Maggiore Di Trieste|Azienda Ospedaliero-Universitaria di Modena|Fondazione Policlinico Universitario Agostino Gemelli IRCCS|Fondazione Salvatore Maugeri|Università degli Studi di Ferrara|Azienda Ospedaliero, Universitaria Pisana|IRCCS Azienda Ospedaliero-Universitaria di Bologna|Ospedale San Paolo|Universita degli Studi di Catania|Azienda Ospedaliera di Padova|University of Palermo|Azienda Ospedaliero-Universitaria di Parma|University of Foggia|Monaldi Hospital|Fondazione Don Carlo Gnocchi Onlus|Ospedale San Donato
Sex ALL
Age ADULT, OLDER_ADULT
Phases NA
Enrollment 130
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 20/06/2019
Completion Date 31/05/2024
Locations Dipartimento Biomedico di Medicina Interna e Specialistica, Università degli Studi di Palermo, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT04102774 

 

Title Effects of Liraglutide on Glycemic Control, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates
NCT Number NCT05360537
U Palermo
Conditions Diabetes Mellitus, Type 2
Interventions Parallel Assignment
Sponsor Antonino Tuttolomondo, University professor of Palermo
Gender All
Age 18 Years to 90 Years   (Adult, Older Adult)
Phases Phase 4
Enrollment 5000
Study Type Interventional (Clinical Trial)
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Care Provider)
Start Date 01/04/2021
Completion Date 31/05/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo
URL https://clinicaltrials.gov/ct2/show/NCT05360537 

 

Study Title A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis
NCT Number NCT04497597
Other IDs: P20-095
Conditions Rheumatoid Arthritis (RA)
Interventions  
Sponsor AbbVie
Sex  
Age ADULT, OLDER_ADULT
Phases  
Enrollment 1532
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 16/10/2020
Completion Date 15/05/2024
Locations Azienda Ospedaliera Civico Di Cristina Benfratelli- P.O. Civico /ID# 228912, Palermo, 90127, Italy | Prof.ssa Giuliana Guggino, Reumatologia, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228160, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04497597 

 

Title

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogrens Syndrome (pSS)

Studio multicentrico, randomizzato, controllato con placebo, in doppio cieco per valutare l’efficacia e la sicurezza di nipocalimab in adulti affetti da sindrome di Sjogrens primaria (SSp)

EudraCT number 2021-000665-32
Conditions Primary Sjogrens Syndrome
sindrome di Sjogrens primaria
Interventions  
Sponsor JANSSEN CILAG INTERNATIONAL NV
Gender Female; Male
Age Adults; Elderly; 
Phases Phase II
Enrollment 150
Study Type Therapeutic exploratory (Phase II)
Study Designs Controlled; Randomised; Parallel group; 
Start Date 11/10/2021
Completion Date 08/05/2024
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000665-32/IT 

 

Study Title Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
NCT Number NCT04854096 Other IDs: NS-018-201
Conditions Primary Myelofibrosis|Post-essential Thrombocythemia Myelofibrosis|Post-polycythemia Vera Myelofibrosis
Interventions DRUG: NS-018|DRUG: Best Available Therapy
Sponsor NS Pharma, Inc. - Collaborators: Nippon Shinyaku Co., Ltd.
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 120
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 31/01/2023
Completion Date 24/04/2024
Locations Polycytemia Vera Unit, Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04854096 

 

Title Reparixin 1200 mg TID as add-on to SoC to Limit Disease Progression in Hospitalised Patients With COVID-19 and Other Community-Acquired Pneumonia. A Multicentre, Randomised, Double-blinded, Placebo-controlled, Phase III Trial (REPAVID-22)
NCT Number NCT05254990
Conditions Infectious Pneumonia
Severe COVID-19
Interventions Parallel Assignment
Sponsor Dompé Farmaceutici S.p.A.
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 3
Enrollment 526 participants
Study Type Interventional
 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Intervention Model Description: male and female patients >18 years, hospitalised for COVID-19, will be assigned (1:1) to receive either oral reparixin (treatment group) or matched placebo (control group) three times a day (TID) for up to 21 days. | Masking: Triple (Participant, Care Provider, Investigator)
Start Date 06/04/2022
Completion Date 01/03/2024
Locations Sperimentatore: Prof. N. Scichilone Centro: U.O.C. di Pneumologia
URL https://clinicaltrials.gov/ct2/show/NCT05254990 

 

Title Prospective Randomized Study on the Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-myelodysplastic Syndromes, Performed Upfront or Preceded by Azacitidine or Conventional Chemotherapy According to the BM-blast Proportion
NCT Number NCT04184505
MDS 0519
Codice Eudract: 2019-003997-25
Conditions High-risk MDS
Interventions Parallel Assignment
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years to 70 Years   (Adult, Older Adult)
Phases Phase 3
Enrollment 274 participants
Study Type Interventional
 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: None (Open Label) | Primary Purpose: Treatment
Start Date 27/11/2020
Completion Date 01/03/2024
Locations Sperimentatore: Prof. S. Siragusa Centro: U.O.C. di Ematologia Sponsor: Fondazione GIMEMA Franco Mandelli Onlus
URL https://clinicaltrials.gov/ct2/show/NCT04184505 

 

Title A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS)
NCT Number NCT04460950
AML2120
Conditions Acute Myeloid Leukemia

Familial Acute Myeloid Leukemia

Myelodysplastic Syndromes
Interventions  
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 237 participants
Study Type Observational
Study Designs Case-Only
Start Date 16/12/2020
Completion Date 31/03/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra
URL https://www.clinicaltrials.gov/ct2/show/NCT04460950 

 

Title Prospective randomized study on the feasibility of allogeneic stem cell transplantation in higher-risk-myelodysplastic syndromes, performed upfront or preceded by azacitidine or conventional chemotherapy, according to the BM-blast proportion (ACROBAT trial)

Studio randomizzato, prospettico, sulla fattibilità del trapianto allogenico di cellule staminali in pazienti affetti da Sindrome mielodisplastica ad alto rischio, eseguito upfront o preceduto da azacitidina o chemioterapia convenzionale, secondo la percentuale di blasti midollari
EudraCT number 2019-003997-25
NCT04184505
Conditions Higher-risk-myelodysplastic syndromes

Sindrome mielodisplastica ad alto rischio
Interventions  
Sponsor FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender Female; Male
Age Adults; Elderly; 
Phases Phase III
Enrollment 274
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled; Randomised; Open; Parallel group; 
Start Date 06/10/2020
Completion Date 01/03/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003997-25/IT
https://www.clinicaltrials.gov/ct2/show/NCT04184505 

 

Title Epidemiology of COVID-19 Infection in Patients With Hematological Malignancies: A European Haematology Association Survey
NCT Number NCT04733729
Conditions COVID-19 Infection in Hematological Malignancies Patients
Interventions  
Sponsor LIVIO PAGANO, Catholic University of the Sacred Heart
Gender All
Age 18 Years to 99 Years   (Adult, Older Adult)
Phases  
Enrollment 3000 participants
Study Type Observational [Patient Registry]
Study Designs Cohort
Start Date 01/03/2020
Completion Date 31/03/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra
URL https://www.clinicaltrials.gov/ct2/show/NCT04733729 

 

Title AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY
NCT Number NCT05567952
C4671042
2022-002827-36 ( EudraCT Number )
Conditions COVID-19
Interventions Drug: nirmatrelvir
Drug: ritonavir
Drug: placebo for nirmatrelvir
Sponsor Pfizer
Gender All
Age 12 Years and older   (Child, Adult, Older Adult)
Phases Phase 2
Enrollment 436
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 19/10/2022
Completion Date 15/02/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo
URL https://www.clinicaltrials.gov/ct2/show/NCT05567952 

 

Study Title EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
NCT Number NCT03594110 Other IDs: 1245-0137|2017-002971-24
Conditions Chronic Kidney Disease
Interventions DRUG: Empagliflozin|DRUG: Matching placebo
Sponsor Sponsor: Boehringer Ingelheim - Collaborators: Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)|Eli Lilly and Company
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 6609
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 31/01/2019
Completion Date 07/02/2024
Locations A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT03594110 

 

Study Title ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)
NCT Number NCT02078427 Other IDs: 061001
Conditions Hemophilia A
Interventions BIOLOGICAL: ADVATE|BIOLOGICAL: ADYNOVI
Sponsor Baxalta now part of Shire - Collaborators: Baxalta Innovations GmbH, now part of Shire
Sex ALL
Age CHILD, ADULT, OLDER_ADULT
Phases  
Enrollment 955
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: 
Start Date 29/06/2011
Completion Date 16/01/2024
Locations U.O.C. di Ematologia, Prof. Sergio Siragusa, AOUP P. Giaccone, Palermo, 90133, Italy|
Study URL https://clinicaltrials.gov/study/NCT02078427 

 

Study Title An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies
NCT Number NCT04581187
Othr ID: GIMEMA-ALLIANCE Platform
Conditions Hematologic Malignancies
Interventions OTHER: Quality of life assessment
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 400
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 12/02/2020
Completion Date 12/01/2024
Locations AO Ospedali Riuniti Villa Sofia Cervello - Palermo - UO Ematologia Con Utmo, Palermo, Italy | AOU Policlinico P. Giaccone - UO Ematologia, Dipartimento Biomedico di Medicina Interna e Specialistica, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT04581187 

 

Study Title Clinical Decision-making, Prognosis, Quality of Life and Satisfaction in Relapsed/Refractory Multiple Myeloma
NCT Number NCT03190525
Othr ID: QoL-MM1016
Conditions Multiple Myeloma
Interventions OTHER: Quality of life questionnaires
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto - Collaborators:
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 520
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 13/11/2017
Completion Date 12/01/2024
Locations U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le Coagulopatie rare nel bambino e nell'adulto, Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone", Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT03190525 

 

Study Title Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
NCT Number NCT03250338
Other IDs: ARO-013|2017-001600-29
Conditions Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Interventions DRUG: Crenolanib|DRUG: Cytarabine|DRUG: Mitoxantrone|DRUG: Placebo Oral Tablet|DRUG: Fludarabine|DRUG: Idarubicin|DRUG: G-CSF
Sponsor Arog Pharmaceuticals, Inc.
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 322
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 06/05/2018
Completion Date 10/01/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa | AO Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT03250338 

 

Study Title Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE
NCT Number NCT04505774
Other IDs: ACTIV-4 ACUTE|1OT2HL156812-01
Conditions Covid19
Interventions DRUG: theraputic heparin|DRUG: prophylactic heparin|DRUG: P2Y12|DRUG: Crizanlizumab Injection|DRUG: SGLT2 inhibitor
Sponsor Matthew Neal MD - Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE4
Enrollment 880
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 09/04/2020
Completion Date 06/01/2024
Locations U.O.C. di Malattie Infettive, Prof. Antonio Cascio, AOU Policlinico di Palermo, Palermo, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT04505774 

  

Study Title Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study)
NCT Number NCT04979468 Other IDs: 2019-004241-32
Conditions HIV-1-infection
Interventions DRUG: DOVATO
Sponsor Societa' Italiana Di Malattie Infettive E Tropicali
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 440
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date 23/03/2021
Completion Date 04/01/2024
Locations A.O.U. Policlinico "Paolo Giaccone", Palermo, PA, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04979468 

 

Study Title A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline.
NCT Number NCT04899271 Other IDs: LDX0419|2020-002966-15
Conditions New-onset Type 1 Diabetes
Interventions DRUG: Ladarixin|OTHER: Placebo
Sponsor Dompé Farmaceutici S.p.A
Sex ALL
Age ADULT
Phases PHASE2
Enrollment 25
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 14/12/2020
Completion Date 04/01/2024
Locations prof.ssa Carla Giordano, U.O.C. Malattie Endocrine, del Ricambio e della Nutrizione, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04899271 

 

Study Title Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia
NCT Number NCT03367299 Other IDs: LAL2317
Conditions Acute Lymphoid Leukemia|Philadelphia Chromosome-Negative B-Cell Precursor
Interventions DRUG: Chemotherapy + Blinatumomab
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 149
Study Type INTERVENTIONAL
Study Design Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date 06/08/2018
Completion Date 02/01/2024
Locations Ospedali Riuniti "Villa Sofia-Cervello", Palermo, Italy | Prof. Sergio Siragusa, Dott.ssa Maria Enza Mitra, U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto - A.U. Policlinico "Paolo Giaccone", Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT03367299 

 

Study Title Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia
NCT Number NCT02602314 Other IDs: CML1415
Conditions Chronyc Myeloid Leukemia
Interventions DRUG: Imatinib|DRUG: Nilotinib
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE4
Enrollment 450
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date 11/11/2016
Completion Date 02/01/2024
Locations Ospedali Riuniti "Villa Sofia-Cervello", Palermo, Italy| Prof. Sergio Siragusa, Dott.ssa Maria Enza Mitra, U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone", Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT02602314