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Promozione della Salute, Materno-Infantile, di Medicina Interna e Specialistica di Eccellenza “G. D’Alessandro”

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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 PIASTRINOPENIA IMMUNE (ITP) E COVID19: indagine nazionale osservazionale retrospettiva e prospettica su incidenza e decorso clinico dei pazienti COVID-19 con ITP pregressa, in atto o de novo. Valutazione generale dell'impatto della pandemia COVID-19 nella gestione dell'ITP.
Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP
NCT Number

NCT04735588

GIMEMA ITP1021
Conditions Immune Thrombocytopenia
ITP
Covid19
ITP Secondary to Infection
Interventions  
Sponsor GIMEMA - Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender  
Age  
Phases  
Enrollment 140
Study Type Observational
Study Designs Observational Model: Case-Only
Time Perspective: Prospective
Start Date 22/08/2022
Completion Date 31/03/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, prof.ssa Mariasanta Napolitano
URL https://asufc.sanita.fvg.it/it/sperimentazioni-cliniche/no-profit/gimema-itp1021.html 

 

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 

 

 

Title A Randomised, Open-Label, Multicentre Clinical Study To Evaluate The Efficacy And Safety Of Topical Applications Of the System VULNOFAST® Plus / VULNOLIGHT® In Addition To The Usual Care Versus Usual Care Alone For The Treatment Of Infected Foot Ulcers In Diabetic Patients (PHOTOFINISH)
NCT Number NCT05613985
MOLT-2019-01
Conditions Diabetic Foot Infection
Interventions Other: Usual Care alone
Device: System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care
Sponsor L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 146 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 14/09/2021
Completion Date 31/12/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Malattie Endocrine, del Ricambio e della Nutrizione, Prof.ssa Carla Giordano
URL https://www.clinicaltrials.gov/ct2/show/NCT05613985 

 

Title ICT Tools for the Diagnosis of Autoimmune Diseases in the Mediterranean Area - CAPITALISATION PROJECT
NCT Number NCT05715970
ACPM32
Conditions Celiac Disease
Interventions Diagnostic Test:  PoCT+questionnaire administration
Sponsor Pasquale Mansueto, University of Palermo
Gender All
Age 12 Years and older   (Child, Adult, Older Adult)
Phases  
Enrollment 25000 participants
Study Type Interventional  (Clinical Trial)
Study Designs Single Group Assignment
Start Date 01/06/2023
Completion Date 31/12/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo, prof. Pasquale Mansueto, prof. Antonio Carroccio
URL https://www.clinicaltrials.gov/ct2/show/NCT05715970 

 

Title The Role of Gut-skin Axis in Psoriasis: a Randomized Placebo-controlled Dietary Approach to Assess Clinical Efficacy in Mild-to-moderate Psoriasis
NCT Number NCT05644782
ACPM30
Conditions Psoriasis
Gluten Sensitivity
Interventions Other: Open wheat challenge
Other: Placebo challenge
Sponsor Pasquale Mansueto, University of Palermo
Gender All
Age 18 Years to 65 Years   (Adult, Older Adult)
Phases  
Enrollment 82 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 01/01/2023
Completion Date 31/12/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo, prof. Pasquale Mansueto, prof.ssa Maria Rita Bongiorno, prof. Antonio Carroccio
URL https://www.clinicaltrials.gov/ct2/show/NCT05644782 

 

Title Urinary Gluten Detection in Patients With Non-celiac Gluten/Wheat Sensitivity
NCT Number NCT04219813
ACPM24
Conditions Non-celiac Gluten/Wheat Sensitivity
Interventions Other: Urinary test
Sponsor Pasquale Mansueto, University of Palermo
Gender All
Age 18 Years to 75 Years   (Adult, Older Adult)
Phases  
Enrollment 40 participants
Study Type Interventional  (Clinical Trial)
Study Designs Single Group Assignment
Start Date 01/01/2021
Completion Date 31/12/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo, Pasquale Mansueto, University of Palermo (Responsible Party)
URL https://www.clinicaltrials.gov/ct2/show/NCT04219813 

 

Title Adaptive, Randomized, Non-inferiority Trial on the Use of Monoclonal Antibodies or Antivirals in Outpatients With Mild or Moderate COVID-19
NCT Number NCT05321394
MANTICO 2
2021-002612-31 ( EudraCT Number )
Conditions COVID-19
Interventions Drug: Sotrovimab
Drug: Tixagevimab Cilgavimab
Drug: Nirmatrelvir Ritonavir
Sponsor Evelina Tacconelli, Azienda Ospedaliera Universitaria Integrata Verona
Gender All
Age 50 Years and older   (Adult, Older Adult)
Phases Phase 3
Enrollment 1095 participants
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 07/03/2022
Completion Date 30/12/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Malattie Infettive, Prof. Antonio Cascio
URL https://www.clinicaltrials.gov/ct2/show/NCT05321394 

 

Title A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis
NCT Number NCT04439526 Other IDs: CR108761|CNTO1959PSO4013
Conditions Psoriasis
Interventions DRUG: Guselkumab
Sponsor Janssen-Cilag S.p.A.
Sex ALL
Age ADULT, OLDER_ADULT
Phases  
Enrollment 400
Study Type OBSERVATIONAL
Study Design Observational Model: |Time Perspective: p
Start Date 06/10/2020
Completion Date 30/12/2023
Locations Dermatologia, Prof.ssa Maria Rita Bongiorno, Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04439526 

  

Title A phase 2, randomized, open-label, multicenter study to evaluate safety and efficacy of single agent selinexor versus treatment of physician's choice in patients with previously treated myelofibrosis

Studio multicentrico di fase 2, randomizzato, in aperto, per valutare la sicurezza e l’efficacia di selinexor come singolo agente rispetto al trattamento scelto dal medico in pazienti con mielofibrosi precedentemente trattata
EudraCT number 2020-003809-60
XPORT - MF-035
Conditions Myelofibrosis

Mielofibrosi
Interventions  
Sponsor Name KARYOPHARM THERAPEUTICS, INC.
Gender Female; Male
Age Adults; Elderly; 
Phases Phase II
Enrollment 112
Study Type Therapeutic exploratory (Phase II)
Study Designs Controlled; Randomised; Open; Parallel group; 
Start Date 31/08/2021
Completion Date 29/12/2023
Locations United States
Italy: A.O.U. Policlinico P. Giaccone Palermo,U.O.C. di Ematologia, Dott. Marco Santoro
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003809-60/IT 

 

Title A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with establishe...
EudraCT Number 2019-001076-11
Conditions Cardiovascular Disease, Atherosclerosis
Interventions  
Sponsor Name Novartis Pharma AG
Gender Male, Female
Age Adults, Elderly
Phases  
Enrollment  
Study Type  
Study Designs  
Start Date 19/12/2019
Completion Date 19/12/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo
Prof. Angelo Baldassare Cefalù, Principal Investigator
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001076-11/IT 

  

Title SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity
SELECT - Effetti di semaglutide sugli esiti cardiovascolari in persone obese o in sovrappeso
EudraCT number 2017-003380-35
Conditions Overweight
Obesity
Sovrappeso
Obesita
Interventions  
Sponsor NOVO NORDISK. S.P.A.
Gender Female; Male
Age Adults; Elderly; 
Phases Phase III
Enrollment 17500
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled; Randomised; Parallel group; 
Start Date 13/12/2018
Completion Date 12/12/2023
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003380-35/IT 

 

Title RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
NCT Number NCT04620733 - Other IDs: CB8025-32048
Conditions Primary Biliary Cholangitis
Interventions DRUG: Seladelpar 10 mg|DRUG: Placebo|DRUG: Seladelpar 5 mg
Sponsor CymaBay Therapeutics, Inc.
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 193
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 21/04/2021
Completion Date 08/11/2023
Locations Prof.ssa Vincenza Calvaruso, U.O.C. di Gastroenterologia, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04620733 

   

Title A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Italy
NCT Number NCT05230615
Conditions Diabetes Mellitus, Type 2
Interventions Drug: Oral semaglutide
Sponsor Novo Nordisk A/S
Gender All
Age age above or equal to 18 years 
Phases  
Enrollment 462
Study Type Observational
Study Designs Observational Model: Cohort
Time Perspective: Prospective
Start Date 01/04/2022
Completion Date 03/11/2023
Locations Sperimentatore: Prof. ssa Carla Giordano Centro: U.O.C. di Endocrinologia Sponsor: Novo Nordisk A/S CRO: IQVIA
URL https://clinicaltrials.gov/ct2/show/NCT05230615 

  

Title A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
NCT Number NCT04568434 - (EudraCT Number: 2020-002536-67)
Conditions Familial Chylomicronemia Syndrome
Interventions Drug: Olezarsen
Drug: Placebo
Sponsor Sponsor: Ionis Pharmaceuticals, Inc.
Collaborator: Akcea Therapeutics
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases Phase 3
Enrollment 66
Study Type Interventional
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Start Date 16/11/2020
Completion Date 31/10/2023
Locations Italy
ASST Grande Ospedale Metropolitano Niguarda - Milano, Italy, 20162
Azienda Ospedaliera Universitaria Federico II - Napoli, Italy, 80131
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Palermo, Italy, 90127
    Prof. Angelo Baldassare Cefalù, Principal Investigator
Azienda Ospedaliero Universitaria Policlinico Umberto I - Roma, Italy, 00161 
 
and other 48 international study locations
URL https://ClinicalTrials.gov/show/NCT04568434

 

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

UNO STUDIO DI FASE 2, INTERVENTISTICO, RANDOMIZZATO, IN DOPPIO CIECO, A DUE BRACCI, PER VALUTARE L’EFFICACIA E LA SICUREZZA DI UN CICLO RIPETUTO DI 5 GIORNI DI NIRMATRELVIR/RITONAVIR RISPETTO A PLACEBO/RITONAVIR IN PARTECIPANTI DI ALMENO 12 ANNI DI ETÀ CON RICOMPARSA DEI SINTOMI DI COVID-19 E POSITIVITÀ AL TEST ANTIGENICO RAPIDO
EudraCT number 2022-002827-36
C4671042
Medical condition SARS-CoV-2 Infection

Infezione da SARS-CoV-2
Interventions  
Sponsor/Collaborators PFIZER INC
Gender Female; Male
Population Age Adolescents (12-17 years); Adults; Elderly; 
Phases Phase II
Enrollment 411
Trial type Therapeutic exploratory (Phase II)
Design of the trial
Start Date 20/02/2023
Completion Date 18/10/2023
Locations United States - A.O.U. Policlinico P. Giaccone Palermo, Prof. Antonio Cascio, U.O.C. Malattie Infettive
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002827-36/IT 

 

Title A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
NCT Number NCT04594707 Other IDs: WA42294|2020-001429-30
Conditions Idiopathic Pulmonary Fibrosis
Interventions DRUG: PRM-151 (Zinpentraxin Alfa)
Sponsor Hoffmann-La Roche
Sex ALL
Age CHILD, ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 117
Study Type INTERVENTIONAL
Study Design Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date 30/08/2021
Completion Date 02/10/2023
Locations prof. Nicola Scichilone, U.O.C. di Pneumologia, Az. Osp. Univ. P. Giaccone, Palermo, Sicilia, 90127, Italy| Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia, Palermo, Sicilia, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04594707 

  

Title A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
NCT Number NCT04552899 Other IDs: WA42293|2020-000791-38
Conditions Idiopathic Pulmonary Fibrosis
Interventions DRUG: PRM-151 (Zinpentraxin Alfa)|DRUG: Placebo
Sponsor Hoffmann-La Roche
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 665
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 19/03/2021
Completion Date 02/10/2023
Locations prof. Nicola Scichilone, U.O.C. di Pneumologia, Az. Osp. Univ. P. Giaccone, Palermo, Sicilia, 90127, Italy| Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia, Palermo, Sicilia, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04552899 

  

Title Contribution of KIR Genes on the Genetic Predisposition to Non-Celiac Wheat Sensitivity
NCT Number NCT05469971
Conditions Non-celiac Wheat Sensitivity
Interventions Genetic: KIR genotyping
Sponsor Pasquale Mansueto, University of Palermo
Gender All
Age 18 Years to 65 Years   (Adult, Older Adult)
Phases  
Enrollment 150 participants
Study Type Observational
Study Designs Observational Model: Case-Control
Time Perspective: Retrospective
Start Date 01/11/2022
Completion Date 30/09/2023
Locations prof. Pasquale Mansueto, University of Palermo
URL https://clinicaltrials.gov/ct2/show/NCT05469971 

 

Title Retro-prospective Observational Study on Risk of Progression in Chronic Phase-Chronic Myeloid Leukemia Patients Eligible for Tyrosine Kinase Inhibitor Discontinuation (TFR - PRO)
NCT Number NCT04621851
TFR-PRO
Conditions Chronic Myeloid Leukemia
Interventions  
Sponsor CARLO GAMBACORTI PASSERINI, University of Milano Bicocca
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 3000 participants
Study Type Observational [Patient Registry]
Study Designs Cohort
Start Date 30/09/2020
Completion Date 30/09/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa,  dott. Accurso
URL https://www.clinicaltrials.gov/ct2/show/NCT04621851 

 

Title Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
NCT Number NCT02548351 Other IDs: 747-303
Conditions Non Alcoholic Steatohepatitis (NASH)
Interventions DRUG: Obeticholic Acid|DRUG: Placebo
Sponsor Intercept Pharmaceuticals
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 2480
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 22/09/2015
Completion Date 15/09/2023
Locations Prof. Salvatore Petta, Gastroenterologia, Dir. Prof. Calogero Cammà, Policlinico Paolo Giaccone di Palermo, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT02548351 

  

Title An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Studio di estensione in aperto per valutare la sicurezza, la tollerabilità e l’efficacia a lungo termine di rozanolixizumab in soggetti con trombocitopenia immune (ITP) primaria persistente o cronica
EudraCT number 2019-000883-40
Conditions Primary Immune Thrombocytopenia

Trombocitopenia immune primaria
Interventions  
Sponsor UCB Biopharma SRL
Gender Female; Male
Age Adults; Elderly; 
Phases Phase III
Enrollment 210
Study Type Therapeutic confirmatory (Phase III)
Study Designs  
Start Date 14/12/2020
Completion Date 11/08/2023
Locations Germany
Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000883-40/IT 

 

Title Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features
NCT Number NCT05723068
IN-IT-980-6382
Conditions Chronic Hepatitis D
Interventions  
Sponsor University of Turin, Italy
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 500 participants
Study Type Observational
Study Designs Cohort
Start Date 24/08/2022
Completion Date 01/07/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo, prof. Antonio Craxì
URL https://www.clinicaltrials.gov/ct2/show/NCT05723068 

 

Title Randomised, Open-label and Parallel Group Trial to Investigate the Effects of Oral BI 685509 Alone or in Combination With Empagliflozin on Portal Hypertension After 8 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis
NCT Number NCT05282121
1366-0029
2021-005171-40 ( EudraCT Number )
Conditions Liver Diseases
Hypertension, Portal
Interventions Parallel Assignment
Sponsor Boehringer Ingelheim
Gender All
Age 18 Years to 75 Years   (Adult, Older Adult)
Phases Phase 2
Enrollment 80 participants
Study Type Interventional
 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: None (Open Label) | Primary Purpose: Treatment
Start Date 26/05/2022
Completion Date 28/07/2023
Locations Sperimentatore: Prof.ssa V. Calvaruso Centro: U.O.C. di Gastroenterologia
URL https://clinicaltrials.gov/ct2/show/NCT05282121 

 

Title Italian adult Immune ThrombocytoPenia (ITP) Registry Investigation on a Dynamic Cohort of Italian Patients With Active ITP
NCT Number NCT03465020
Conditions Intervention/treatment 

Idiopathic Thrombocytopenic Purpura

Other: Observation
Interventions  
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases  
Enrollment 861 participants
Study Type Observational [Patient Registry]
Study Designs Cohort
Start Date 15/10/2018
Completion Date 01/07/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo  - UO Ematologia, Prof. Sergio Siragusa 
URL https://www.clinicaltrials.gov/ct2/show/NCT03465020 

 

Title Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT)
NCT Number NCT04423302 Other IDs: PEC16075|2020-A00604-35
Conditions Prediabetic State|Diabetes type2|Dysglycemia
Interventions DIETARY_SUPPLEMENT: TOTUM-63 3 intakes per day|DIETARY_SUPPLEMENT: Placebo 3 intakes per day|DIETARY_SUPPLEMENT: TOTUM-63 2 intakes per day
Sponsor Valbiotis - Collaborators: Biofortis Mérieux NutriSciences
Sex ALL
Age ADULT, OLDER_ADULT
Phases NA
Enrollment 636
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date 07/08/2020
Completion Date 23/06/2023
Locations prof. Silvio Buscemi, U.O.C. Nutrizione Clinica, Obesità e Metabolismo, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04423302 

  

Title A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
NCT Number NCT04771273 Other IDs: 1404-0043|2020-002723-11
Conditions Non-alcoholic Steatohepatitis (NASH)
Interventions DRUG: BI 456906|DRUG: Placebo
Sponsor Boehringer Ingelheim
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 295
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 27/04/2021
Completion Date 12/06/2023
Locations Prof. Salvatore Petta, Gastroenterologia, Dir. Prof. Calogero Cammà, A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04771273 

 

Title A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)
NCT Number NCT04374253 Other IDs: WN42171|2020-000766-42
Conditions Alzheimer Disease
Interventions DRUG: Gantenerumab|DRUG: Gantenerumab
Sponsor Hoffmann-La Roche
Sex ALL
Age CHILD, ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 1379
Study Type INTERVENTIONAL
Study Design Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date 02/01/2021
Completion Date 03/06/2023
Locations Prof. Mario Barbagallo, UOC Geriatria, Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04374253 

 

 

Title A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
NCT Number NCT05420961
V116-006
jRCT2071220025 ( Registry Identifier: jRCT )
2021-006679-41 ( EudraCT Number )
Conditions Pneumonia, Pneumococcal
Interventions Parallel Assignment
Sponsor Merck Sharp & Dohme LLC
Gender All
Age 50 Years and older   (Adult, Older Adult)
Phases Phase 3
Enrollment 700 participants
Study Type Interventional
                 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Double (Participant, Investigator) | Masking Description: Cohorts 1 and 2: participants, investigator, Sponsor Cohort 3: no blinding
Start Date 12/07/2022
Completion Date 18/05/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo: Claudio Costantino (MED/42), Francesco Vitale (MED/42), Carmelo Massimo Maida (MED/42), Fabio Tramuto (MED/42), Vincenzo Restivo (MED/42)
URL https://clinicaltrials.gov/ct2/show/NCT05420961 

 

Title A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease
NCT Number NCT05378529 - AMG 20210057
Conditions Atherosclerotic Cardiovascular Disease
Interventions Other: Lp(a) Screening
Sponsor Amgen
Gender All
Age 18 Years to 85 Years (Adult, Older Adult)
Phases Not Applicable
Enrollment 40000
Study Type Interventional
Study Designs Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Start Date 19/04/2022
Completion Date 22/05/2023
Locations Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi - Bologna, Italy, 40138
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Brescia, Italy, 25123
Azienda Ospedaliera Sant Anna e San Sebastiano - Caserta, Italy, 81100
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna - Ferrara, Italy, 44124
Ospedale Policlinico San Martino IRCCS - Genova, Italy, 16132
IRCCS Centro Cardiologico Monzino - Milano, Italy, 20138
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda - Milano, Italy, 20162
Azienda Ospedaliera Universitaria Maggiore della Carita - Novara, Italy, 28100
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Palermo, Italy, 90127
     Prof. Angelo Baldassare Cefalù, Principal Investigator
Fondazione Policlinico Tor Vergata - Roma, Italy, 00133
IRCCS Istituto Clinico Humanitas - Rozzano MI, Italy, 20089
Azienda Ospedaliera Ordine Mauriziano di Torino - Torino, Italy, 10128
and other 607 international study locations
URL https://ClinicalTrials.gov/show/NCT05378529 
https://www.amgentrials.com/study/?id=20210057 

 

Title A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)
NCT Number NCT04270760
20180109

2019-003688-23 ( EudraCT Number )
Conditions  
Interventions Parallel Assignment
Sponsor Amgen
Gender All
Age 18 Years to 80 Years   (Adult, Older Adult)
Phases  
Enrollment 700 participants
Study Type Interventional
 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Double (Participant, Investigator) | Primary Purpose: Treatment
Start Date 28/07/2020
Completion Date 18/05/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo
URL https://clinicaltrials.gov/ct2/show/NCT04270760 

 

Title Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
NCT Number NCT02118584 Other IDs: GA28951|2013-004435-72
Conditions Ulcerative Colitis
Interventions DRUG: Etrolizumab
Sponsor Hoffmann-La Roche
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 1822
Study Type INTERVENTIONAL
Study Design Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date 15/09/2014
Completion Date 10/05/2023
Locations Prof. Sergio Peralta, Gastroenterologia, Dir. Prof. Calogero Cammà, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT02118584 

 

Title Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
NCT Number NCT04888585 Other IDs: M20-466|2020-005303-39
Conditions Rheumatoid Arthritis (RA)
Interventions DRUG: ABBV-154|DRUG: Placebo
Sponsor AbbVie
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 473
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 06/02/2021
Completion Date 08/04/2023
Locations Prof.ssa Giuliana Guggino, Reumatologia, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583, Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04888585 

 

Title The Benefit/Risk Profile of Pegylated Proline-Interferon Alpha-2b (AOP2014) Added to the Best Available Strategy Based on Phlebotomies in Low-risk Patients With Polycythemia Vera (PV). The Low-PV Randomized Trial
NCT Number NCT03003325
Low-PV
Conditions Polycythemia Vera
Interventions  
Sponsor Fondazione per la Ricerca Ospedale Maggiore
Gender All
Age 18 Years to 60 Years   (Adult)
Phases Phase 2
Enrollment  
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 02/02/2017
Completion Date 31/03/2023
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT03003325 

 

Title A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC).

Studio in due parti, randomizzato, controllato verso placebo, in doppio cieco, multicentrico, di Fase 3 per valutare l’efficacia e la sicurezza di linerixibat per il trattamento del prurito colestatico nei partecipanti con colangite biliare primitiva (PBC).
EudraCT number 2021-000007-21
Medical condition Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC).

Prurito colestatico da moderato a severo con colangite biliare primitiva (PBC).
Interventions  
Sponsor/Collaborators GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 230
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; 
Start Date 24/06/2021
Completion Date 21/03/2023
Locations United Kingdom - A.O.U. Policlinico P. Giaccone Palermo, CALVARUSO VINCENZA
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000007-21/IT 

 

Title Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
NCT Number NCT03444870 Other IDs: WN29922|2017-001364-38
Conditions Alzheimer Disease
Interventions DRUG: Gantenerumab|DRUG: Placebo
Sponsor Hoffmann-La Roche
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE3
Enrollment 1054
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date 06/06/2018
Completion Date 17/02/2023
Locations Prof. Mario Barbagallo, UOC Geriatria, Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT03444870 

  

Title Reparixin 1200 mg three times a day as add-on therapy to standard of care to limit disease progression in hospitalised adult patients with COVID-19. A multinational, multicentre, randomised, double blinded, placebo-controlled, parallel-group phase III trial.

Reparixin 1200 mg tre volte al giorno come terapia aggiuntiva allo standard of care per limitare la progressione della malattia in pazienti adulti ospedalizzati per COVID-19. Studio di fase III a gruppi paralleli, internazionale, multicentrico, randomizzato, doppio cieco, controllato con placebo.
EudraCT number 2021-006951-32
Medical condition COVID-19

COVID-19
Interventions  
Sponsor/Collaborators DOMPé FARMACEUTICI S.P.A.
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 450
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Parallel group; 
Start Date 02/08/2022
Completion Date 29/01/2023
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo, SCICHILONE NICOLA
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-006951-32/IT 

 

Title EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial
NCT Number NCT04891133 Other IDs: EU SolidAct|2022-500385-99-00
Conditions COVID-19|Emerging Infectious Disease
Interventions DRUG: Baricitinib|DRUG: Placebo
Sponsor Oslo University Hospital - Collaborators: Institut National de la Santé Et de la Recherche Médicale, France|Epidemiological and Clinical Research Information Network
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2|PHASE3
Enrollment 290
Study Type INTERVENTIONAL
Study Design Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date 06/03/2021
Completion Date 23/01/2023
Locations U.O.C. di Malattie Infettive, Prof. Antonio Cascio, AOU Policlinico "P. Giaccone", Palermo, 90127, Italy|
Study URL https://clinicaltrials.gov/study/NCT04891133 

 

Title Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
NCT Number NCT04023396 Other IDs: ABX464-104
Conditions Ulcerative Colitis
Interventions DRUG: ABX464
Sponsor Abivax S.A.
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 217
Study Type INTERVENTIONAL
Study Design Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date 13/01/2020
Completion Date 03/01/2023
Locations Dott.ssa Maria Cappello, Gastroenterologia , Direttore Prof. Calogero Cammà, Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT04023396 

 

Title Activity and Risk Profile of Ponatinib in Chronic Phase Patients With Chronic Myeloid Leukemia Resistant to Imatinib
NCT Number NCT02398825 Other IDs: CML1315|2015-001102-34
Conditions Chronic Myeloid Leukemia|Chronic Phase|Adults
Interventions DRUG: Ponatinib
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Sex ALL
Age ADULT, OLDER_ADULT
Phases PHASE2
Enrollment 16
Study Type INTERVENTIONAL
Study Design Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date 23/06/2016
Completion Date 02/01/2023
Locations AO Ospedali Riuniti Villa Sofia Cervello - Palermo - UO Ematologia con UTMO, Palermo, Italy| Dott. Vincenzo Accurso, Ematologia, Dir. Prof. Sergio Mario Siragusa,AOU Policlinico P. Giaccone - Palermo, Palermo, Italy|
Study URL https://clinicaltrials.gov/study/NCT02398825 

   

Title Not-celiac Wheat Sensitivity (NCWS) in Patients With Irritable Bowel Syndrome. Randomized Double-Blind Placebo-Controlled Trial (Wheat vs Placebo) for Bio-markers Identification of NCWS and Understanding Its Pathogenetic Mechanisms.
NCT Number NCT01762579
Conditions Not-celiac Wheat Sensitivity
Interventions Parallel Assignment
Dietary Supplement: wheat flour
Dietary Supplement: Xylose
Sponsor Pasquale Mansueto, University of Palermo
Gender All
Age 18 Years to 65 Years   (Adult, Older Adult)
Phases  
Enrollment 100 participants
Study Type Interventional
 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | Primary Purpose: Diagnostic
Start Date 01/01/2012
Completion Date 01/01/2023
Locations Internal Medicine, University Hospital
Palermo, Italy, 90100
Contact: Antonio Carroccio, PHD
Contact: Pasquale Mansueto, MD
Sub-Investigator: Alberto D'Alcamo, MD
Sub-Investigator: Giusi Randazzo, MD
Sub-Investigator: Miriam Carta, MD
Sub-Investigator: Giuseppe Taormina, MD 
URL https://clinicaltrials.gov/ct2/show/NCT01762579 

 

Full title Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy.
NCT Number NCT03091127
Conditions Multiple Myeloma
Sponsor/Collaborators Amgen
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 705 participants
Study Type Observational
Study Designs Cohort
Start Date 14/03/2017
Completion Date 12/12/2022
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Dott. Cirino Botta
URL https://www.clinicaltrials.gov/ct2/show/NCT03091127 

 

Title A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes
NCT Number NCT04460885
NN1436-4477

U1111-1247-3878 ( Other Identifier: World Health Organization (WHO) )

2020-000442-34 ( EudraCT Number )
Conditions Diabetes Mellitus, Type 2
Interventions Parallel Assignment
Sponsor/Collaborators Novo Nordisk A/S
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 3
Enrollment 5000 participants
Study Type Interventional
 (Clinical Trial)
Study Designs Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: None (Open Label) | Primary Purpose: Treatment
Start Date 25/11/2020
Completion Date 01/12/2022
Locations A.O.U. Policlinico P. Giaccone di Palermo
URL https://clinicaltrials.gov/ct2/show/NCT04460885 

 

Title Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & Validation of Imaging Modality Performance Across the NAFLD Spectrum in a Prospectively Recruited Cohort
NCT Number NCT05479721
IRAS ID 250344
18/LO/1953 (Other Identifier: NHS Health Research Authority)
Conditions NAFLD

NASH

NASH - Nonalcoholic Steatohepatitis

Fibrosis, Liver

Steatosis of Liver
Interventions  
Sponsor/Collaborators University of Oxford
Gender All
Age 18 Years to 100 Years   (Adult, Older Adult)
Phases  
Enrollment 450 participants
Study Type Observational
Study Designs Cohort
Start Date 04/09/2019
Completion Date 31/10/2022
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastroenterologia, prof. Salvatore Petta
URL https://www.clinicaltrials.gov/ct2/show/NCT05479721 

 

Title Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)
NCT Number NCT05289271 - (EudraCT Number: 2021-004053-23)
Conditions Vaccines, Combined
Hexavalent Vaccine
Interventions Biological: Vaxelis™
Sponsor/Collaborators Merck Sharp & Dohme LLC
Gender All
Age 11 Months to 13 Months (Child)
Phases Phase 4
Enrollment 169
Study Type Interventional
Study Designs Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Start Date 25/03/2022
Completion Date 30/08/2022
Locations

A.O.U. Policlinico Paolo Giaccone ( Site 0102) - Palermo, Sicilia, Italy, 90127
URL https://ClinicalTrials.gov/show/NCT05289271 



Title Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE)
NCT Number NCT05204238
Conditions Heart Failure|Heart Failure With Preserved Ejection Fraction|Heart Failure With Mid Range Ejection Fraction|Heart Failure With Reduced Ejection Fraction
Interventions Diagnostic Test: Transthoracic Echocardiography
Sponsor/Collaborators University of Siena|European Association of Cardiovascular Imaging
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 998
Study Type Observational
Study Designs Observational Model: Cohort|Time Perspective: Prospective
Start Date 01/09/2020
Completion Date 30/11/2022
Locations Italy|Cardiology Unit, Department of Excellence of Sciences for Health Promotion and Mothernal-Child Care, Internal Medicine and Specialities (ProMISE), University of Palermo, University Hospital Paolo Giaccone, Palermo
URL https://ClinicalTrials.gov/show/NCT05204238 

 

Title SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance
NCT Number NCT04352556
HM-COVID 19-ITALY
Conditions SARS-CoV-2 Infection

Hematological Malignancies
Sponsor/Collaborators Francesco Passamonti, Ospedale di Circolo - Fondazione Macchi
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 250 participants
Study Type Observational
Study Designs Cohort
Start Date 07/04/2020
Completion Date 01/10/2022
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04352556 

 

Title A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

Studio di fase 3 multicentrico, randomizzato, in doppio cieco, controllato verso placebo a gruppi paralleli per valutare l'efficacia e sicurezza di CSL112 in soggetti affetti da sindrome coronarica acuta
EudraCT number 2017-000996-98
Medical condition Acute Coronary Syndrome

Sindrome coronarica acuta
Interventions  
Sponsor/Collaborators CSL BEHRING GMBH
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 17400
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Parallel group; 
Start Date 19/06/2018
Completion Date 28/07/2022
Locations United States - A.O.U. Policlinico P. Giaccone Palermo, NOVO GIUSEPPINA
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000996-98/IT 

 

Title REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma
NCT Number NCT03289273
Conditions Intervention/treatment 

Liver Neoplasms

Drug: Regorafenib (Stivarga, BAY73-4506)
Sponsor/Collaborators Bayer
Gender All
Age Child, Adult, Older Adult
Phases  
Enrollment  
Study Type Observational
Study Designs Cohort
Start Date 13/09/2017
Completion Date 27/07/2022
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Gastroenterologia ed Epatologia, Prof. Vito Di Marco
URL https://www.clinicaltrials.gov/ct2/show/NCT03289273 

 

Title Retrospective Observational Study on Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections - DALBADIA Study
NCT Number

NCT04959799

146(Z)PO20094
Conditions Intervention/treatment 

Diabetes

Infection
Interventions Drug: Dalbavancin
Sponsor/Collaborators Aziende Chimiche Riunite Angelini Francesco S.p.A
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 98
Study Type Observational
Study Designs Cohort
Start Date 02/01/2022
Completion Date 31/05/2022
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Malattie Infettive, Prof. Antonio Cascio
URL https://www.clinicaltrials.gov/ct2/show/NCT04959799 

 

Title A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT Number NCT03818607
ABP959
Conditions Paroxysmal Nocturnal Hemoglobinuria
Sponsor/Collaborators Amgen
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 3
Enrollment  
Study Type Interventional  (Clinical Trial)
Study Designs Crossover Assignment
Start Date 24/04/2019
Completion Date 12/07/2022
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT03818607 

 

Title A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia, la sicurezza e la tollerabilità di rozanolixizumab in soggetti adulti con trombocitopenia immune primaria (ITP) persistente o cronica
EudraCT number 2019-003451-11
TP-0006
Medical condition Primary Immune Thrombocytopenia

trombocitopenia immune primaria
Sponsor/Collaborators UCB Biopharma SRL
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 105
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Parallel group; 
Start Date 05/04/2020
Completion Date 05/05/2022
Locations Germany - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003451-11/IT 

 

Title A Multicenter, Non-Interventional Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Patients With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment
NCT Number NCT04165135
Conditions Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor

Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor

Haemophilia A
Interventions Drug: Standard of Care for Haemophilia A
Sponsor/Collaborators Hoffmann-La Roche
Gender All
Age 12 Years to 50 Years   (Child, Adult)
Phases  
Enrollment 107
Study Type Observational
Study Designs Cohort
Start Date 24/02/2020
Completion Date 28/04/2022
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04165135 

 

Title Evaluate the Efficacy of Sorafenib in Renal Cell Carcinoma Patients After a Radical Resection of the Metastases
NCT Number NCT01444807
Conditions Metastatic Renal Cell Carcinoma
Interventions Drug: sorafenib
Sponsor/Collaborators Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 2
Enrollment 132
Study Type Interventional
Study Designs Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date 01/12/2011
Completion Date 01/03/2022
Locations Italy|Vittorio Gebbia, Palermo
URL https://ClinicalTrials.gov/show/NCT01444807 

 

Title Immunogenicity and Safety of DTaP-IPV-HB-PRP~T Combined Vaccine Given at 3, 5, and 12 Monhs of Age Concomitantly or Sequentially 4CMenB Vaccine in Italian Infants

Immunogenicità e sicurezza del vaccino combinato DTaP-IPVHB-PRP~T somministrato a 3, 5 e 12 mesi di età in concomitanza o in sequenza al vaccino 4CMenB a infanti italiani
EudraCT number 2019-002585-12
Medical condition Haemophilus influenzae type b immunisation

Immunizzazione Haemophilus influenzae di tipo B
Sponsor/Collaborators SANOFI PASTEUR
Gender Female; Male
Population Age Infants and toddlers (28 days-23 months); 
Phases Phase IV
Enrollment 396
Trial type Therapeutic use (Phase IV)
Design of the trial Controlled; Randomised; Open; Parallel group; Disegno complesso (vaccino somministrato in concomitanza o in sequenza)

Complex design (vaccine administrated concomitantly or sequentially)
Start Date 08/03/2020
Completion Date 03/11/2021
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-002585-12/IT

 

Title The Role of Benralizumab on airway Remodeling Assessed by HRCT in severe asthma (BREATH Study)
Il ruolo del Benralizumab sul rimodellamento delle vie aeree nell'asma grave valutato tramite HRCT (Studio BREATH)
NCT Number 2018-002498-23 (EudraCT) - ESR-16-12340 (Sponsor's Protocol Code Number)
Conditions SEVERE ASTHMA
Interventions  
Sponsor/Collaborators A.O.U. POLICLINICO “PAOLO GIACCONE” DI PALERMO
Gender All
Age Adults, Elderly
Phases Phase 3
Enrollment  
Study Type Therapeutic confirmatory (Phase III)
Study Designs

Controlled
Randomised
Double blind
Parallel group

Single-center, randomized, double-bind, placebo-controlled, longitudinal, parallel group study
Start Date 17/07/2019
Completion Date 17/07/2021
Locations Prof. Nicola Scichilone, A.O.U. Policlinico P. Giaccone di Palermo
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002498-23/IT 

 

Title Intestinal preparation with new 1 L Peg + Asc solution or with gold standard 4 L Peg in split dose. Multicenter randomized controlled trial (OVER).

Preparazione intestinale con la nuova soluzione 1 L Peg + Asc o con la standard 4 L Peg in split dose. Studio multicentrico randomizzato controllato (OVER).
EudraCT number 2018-004543-24
Medical condition Screening or surveillance or diagnostic colonoscopy.

Colonscopia di screening o sorveglianza o diagnostica.
Sponsor/Collaborators Provincia Religiosa di S.Pietro Ordine Ospedaliero San Giovanni di Dio Fatebenefratelli
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase IV
Enrollment 400
Trial type Therapeutic use (Phase IV)
Design of the trial Controlled; Randomised; Single blind; Parallel group; 
Start Date 29/01/2021
Completion Date 29/04/2021
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004543-24/IT 

  

Full Title A phase II, single-arm, multicenter study of full treatment-free remission in patients with chronic myeloid leukemia in chronic phase treated with nilotinib in first-line therapy who have achieved a sustained deep molecular response for at least 1 year: DANTE study

Studio di fase II, multicentrico, con singolo braccio di trattamento, sulla remissione totale libera da trattamento in pazienti con leucemia mieloide cronica in fase cronica trattati con nilotinib in terapia di prima linea che hanno ottenuto una risposta molecolare profonda sostenuta per almeno un anno: studio DANTE
EudraCT number 2018-002898-21
CAMN 107 AIT 15 (DANTE)
Medical condition Patients with chronic myeloid leukemia in chronic phase treated with nilotinib in first-line therapy who have achieved a sustained, deep molecular response for at least 1 year.

Pazienti con leucemia mieloide cronica in fase cronica trattati con nilotinib in terapia di prima linea che hanno ottenuto una risposta molecolare profonda sostenuta per almeno un anno.
Sponsor/Collaborators NOVARTIS FARMA S.P.A.
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 136
Trial type Therapeutic exploratory (Phase II)
   
Start Date 25/10/2018
Completion Date 23/03/2021
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/2018-002898-21/IT 

 

Full Title A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patient with newLy diagnosed, high-risk acute prOmyelocytic leukemia

A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patient with newLy diagnosed, high-risk acute prOmyelocytic leukemia 
EudraCT number

2015-001151-68

TUD-APOLLO-064
Medical condition Acute promyelocytic leukemia

Leucemia promielocitica acuta
Sponsor Name TECHNISCHE UNIVERSITäT DRESDEN
Gender Female; Male
Population Age Adults; 
Phases Phase III
Enrollment 280
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Open; Parallel group; 
Start Date 25/08/2015
Completion Date 19/02/2021
Locations Germany
Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-001151-68/IT 

 

Full title Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms
NCT Number NCT04192916
Conditions ntervention/treatment 

Myeloproliferative Neoplasm

Drug: DOACs
Sponsor/Collaborators Fondazione per la Ricerca Ospedale Maggiore
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 2
Enrollment 237 participants
Study Type Observational
Study Designs Cohort
Start Date 01/09/2019
Completion Date 31/12/2020
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04192916 

 

Title A SINGLE-ARM, MULTICENTER PHASE IIIB CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF PROPHYLACTIC EMICIZUMAB IN HEMOPHILIA A PATIENTS WITH INHIBITORS

STUDIO CLINICO DI FASE IIIB, A SINGOLO BRACCIO, MULTICENTRICO, PER LA VALUTAZIONE DELLA SICUREZZA E DELLA TOLLERABILIT¿ DELLA PROFILASSI CON EMICIZUMAB IN PAZIENTI AFFETTI DA EMOFILIA A CON INIBITORI
EudraCT number 2016-004366-25
NCT03191799
Medical condition Hemophilia A

Emofilia A
Sponsor/Collaborators F. HOFFMANN - LA ROCHE LTD.
Gender Female; Male
Population Age Adolescents (12-17 years); Adults; Elderly; 
Phases Phase III
Enrollment 200
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Open; 
Start Date 27/07/2017
Completion Date 26/07/2020
Locations Switzerland
Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004366-25/IT
https://www.clinicaltrials.gov/ct2/show/NCT03191799

 

Title A double blind, double dummy, multicenter, randomized, placebo- and active-controlled clinical trial to evaluate effectiveness of Tricortin 1000 in patients affected by chronic low back pain

Studio clinico multicentrico, randomizzato, in doppio cieco,doppio dummy, controllato verso placebo e verso farmaco attivo, con lo scopo di valutare l'efficacia di Tricortin 1000 in pazienti affetti da LBP cronico
EudraCT number 2018-002003-33
Medical condition Low Back Pain

Lombalgia, lombocruralgia, lombosciatalgia
Interventions  
Sponsor/Collaborators FIDIA FARMACEUTICI S.P.A.
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase IV
Enrollment 300
Trial type Therapeutic use (Phase IV)
Design of the trial Controlled; Randomised; Parallel group; Doppio dummy

Double dummy
Start Date 12/12/2018
Completion Date 11/03/2020
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002003-33/IT

 

Title

Open-label study to evaluate the safety, tolerability, and efficacy of LOmitapide for the treatment of patients with Familial CHylomicroNEmia Syndrome

Studio in aperto per valutare sicurezza, tollerabilità ed efficacia di Lomitapide per il trattamento di pazienti affetti da Sindrome Chilomicronemica Familiare
NCT Number 2018-002911-80 (EudraCT) - LOCHNES (Sponsor's Protocol Code Number)
Conditions Familial Chylomicronemia Syndrome
Sindrome Chilomicronemica Familiare
Interventions  
Sponsor/Collaborators A.O.U. POLICLINICO “PAOLO GIACCONE” DI PALERMO
Gender All
Age Adults, Elderly
Phases Phase 3
Enrollment  
Study Type Therapeutic confirmatory (Phase III)
Study Designs

Studio in aperto
Open Label
Start Date 18/12/2018
Completion Date 18/06/2019
Locations A.O.U. Policlinico P. Giaccone di Palermo
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002498-23/IT 

 

Title

Study to Investigate the Efficacy of elbasvir/grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naive, HCV-Infected Patients With non-severe Fibrosis, with or without glucose abnormalities EGG 18.

Studio per valutare l'efficacia del trattamento di Elbasvir/Grazoprevir, in dose fissa combinata, per 8 settimane in pazienti con infezione da HCV Naive al trattamento G1b con fibrosi non severa e con o senza anormalità glucidica e EGG 18
NCT Number 2017-003710-58 (EudraCT Number)
Conditions Vaccines, Combined
Hexavalent Vaccine
Interventions Biological: Vaxelis™
Sponsor/Collaborators A.O.U. POLICLINICO “PAOLO GIACCONE” DI PALERMO
Gender All
Age Adults, Elderly
Phases Phase 3
Enrollment 169
Study Type Therapeutic confirmatory (Phase III)
Study Designs Open
Start Date 17/07/2018
Completion Date 17/05/2019
Locations

A.O.U. POLICLINICO “PAOLO GIACCONE” DI PALERMO
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003710-58/IT 

 

Title Randomized Study of the Treatment of Primary Immune Thrombocytopenic Purpura (ITP) in Newly Diagnosed Untreated Adult Patients. Comparison of Standard Dose Prednisone Versus High-dose Dexamethasone.
NCT Number NCT00657410
Conditions Nonneoplastic Condition
Interventions  
Sponsor/Collaborators Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years to 80 Years   (Adult, Older Adult)
Phases Phase 3
Enrollment  
Study Type Interventional  (Clinical Trial)
Study Designs Parallel Assignment
Start Date 14/04/2008
Completion Date 20/02/2017
Locations A.O.U. Policlinico P. Giaccone di Palermo - Divisione di Ematologia con trapianto di midollo - prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT00657410

 

Title

 Metabolic Effects of Furosemide +HSS in Refractory Ascites
NCT Number NCT02821377
Conditions Ascites|Cirrhosis
Interventions Drug: intravenous furosemide|Drug: Hypertonic saline solutions|Procedure: Seriated paracentesis
Sponsor/Collaborators University of Palermo
Gender All
Age 18 Years to 80 Years   (Adult, Older Adult)
Phases Phase 2
Enrollment 40
Study Type Interventional
Study Designs Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
Start Date 01/12/2013
Completion Date 01/04/2016
Locations Antonino Tuttolomondo, Palermo, Italy|Internal Medicine Ward of Palermo University Hospital, Palermo, Italy|Internal Medicine Ward, University of Palermo, Palermo, Italy
URL https://ClinicalTrials.gov/show/NCT02821377 

 

 

Title Nickel Allergy and Systemic Nickel Allergy Syndrome in Non Celiac Wheat Sensitivity
NCT Number NCT02750735
Conditions Non Celiac Wheat Sensitivity
Interventions  
Sponsor/Collaborators University of Palermo
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 200
Study Type Observational
Study Designs Observational Model: Case-Only
Start Date 01/01/2001
Completion Date 01/03/2016
Locations Antonio Carroccio, Sciacca, Agrigento, Italy|Pasquale Mansueto, Palermo, Italy
URL https://ClinicalTrials.gov/show/NCT02750735 

 

 

Title Nickel Allergy and Systemic Nickel Allergy Syndrome in Non Celiac Wheat Sensitivity
NCT Number NCT02750735
Conditions Non Celiac Wheat Sensitivity
Interventions  
Sponsor/Collaborators University of Palermo
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 200
Study Type Observational
Study Designs Observational Model: Case-Only
Start Date 01/01/2001
Completion Date 01/03/2016
Locations Antonio Carroccio, Sciacca, Agrigento, Italy|Pasquale Mansueto, Palermo, Italy
URL https://ClinicalTrials.gov/show/NCT02750735 

 

 

Title Fermented Milk on the Appearance of Common Winter Infectious Diseases
NCT Number NCT02367612
Conditions Acute Gastroenteritis|Upper Respiratory Tract Infections
Interventions Dietary Supplement: Fermented milk|Dietary Supplement: Placebo
Sponsor/Collaborators Federico II University
Gender All
Age 12 Months to 48 Months   (Child)
Phases Phase 2
Enrollment 140
Study Type Interventional
Study Designs Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
Start Date 01/12/2014
Completion Date 01/06/2015
Locations Fabio Mosca, Milan, Italy|university of naples federico II, Naples, Italy|Giovanni Corsello, Palermo, Italy
URL https://ClinicalTrials.gov/show/NCT02367612 

 

Title Troponin I Release After High Diuretic Doses
NCT Number NCT01419132
Conditions ADHF
Interventions Drug: Furosemide
Sponsor/Collaborators University of Palermo
Gender All
Age 18 Years to 95 Years   (Adult, Older Adult)
Phases Phase 4
Enrollment 60
Study Type Interventional
Study Designs Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date 01/08/2011
Completion Date 01/09/2011
Locations Department of Internal and Specialty Medicine, Palermo, Italy|Gaspare Parrinello, Palermo, Italy|GF Ingrasasia Hospital, Palermo, Italy
URL https://ClinicalTrials.gov/show/NCT01419132 

 

 

 

Title Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants
NCT Number NCT00623987
Conditions Deep Vein Thrombosis
Interventions Drug: warfarin accordingly INR value
Sponsor/Collaborators Azienda Ospedaliera Universitaria Policlinico
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases Phase 4
Enrollment 500
Study Type Interventional
Study Designs Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
Start Date 01/06/1999
Completion Date 01/01/2008
Locations Sergio Siragusa, Palermo, Italy
URL https://ClinicalTrials.gov/show/NCT00623987