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

Ascolta
Descrizione sintetica Patologie Data di autorizzazione del Comitato Etico Codice o acronimo identificativo attribuito internamente per la codifica del Trial Con pazienti pediatrici (Si/No) Con pazienti affetti da malattie rare (Si/No) Ente Coordinatore Trial Persona referente per il Trial
Effetto del consumo acuto e cronico di olio salutista da parte di soggetti giovani ed anziani volontari sani 04/05/2021 PROGETTO TRIAL NO NO Dip. Promise Prof. Maurizio Averna
Valutazione dei livelli plasmatici di PCSK9 in varie fasce d'età pediatriche volontari sani 15/03/2022 Not available SI NO Dip. Promise Prof. Maurizio Averna
Ascolta
Title A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination with Ruxolitinib Versus Best Available Therapy in Subjects with Relapsed/Refractory Myelofibrosis (TRANSFORM-2)

Studio Clinico Randomizzato, In Aperto di Fase 3 per Valutare l’Efficacia e la Sicurezza di Navitoclax in Combinazione con Ruxolitinib rispetto alla Miglior Terapia Disponibile in Soggetti Affetti da Mielofibrosi Recidivante/Refrattaria
EudraCT number 2020-000557-27
TRANSFORM-2 M20-178
Medical condition Myelofibrosis

Mielofibrosi
Interventions  
Sponsor/Collaborators ABBVIE DEUTSCHLAND GMBH & CO. KG 
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 330
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Open; Parallel group; 
Start Date 27/10/2020
Completion Date 23/01/2032
Locations United Kingdom
Italy: A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000557-27/IT 

 

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

Trattamento combinato di immunochemioterapia standard vs immunoterapia standard e chemioterapia a ridotto numero di cicli per il trattamento in prima linea di pazienti con Linfoma Follicolare ad elevato carico tumorale. Studio randomizzato in aperto di fase III della Fondazione Italiana Linfomi.
EudraCT number

2020-003277-22

FIL FOLL 19

Medical condition High tumor burden Follicular Lymphoma

Linfoma Follicolare ad elevato carico tumorale.
Interventions  
Sponsor/Collaborators FONDAZIONE ITALIANA LINFOMI ONLUS
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 602
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Open; 
Start Date 10/04/2021
Completion Date 25/10/2029
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott.ssa Salvatrice Mancuso
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003277-22/IT 

 

Title LOWER: Lomitapide Observational Worldwide Evaluation Registry
NCT Number NCT02135705
AEGR-733-025
Conditions Homozygous Familial Hypercholesterolemia
Interventions Parallel Assignment
Sponsor/Collaborators Amryt Pharma
Gender All
Age Child, Adult, Older Adult
Phases  
Enrollment 300 participants
Study Type Observational [Patient Registry]
Study Designs

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Start Date 18/03/2014
Completion Date 01/09/2028
Locations A.O.U. Policlinico P. Giaccone di Palermo
     Prof. Angelo Baldassare Cefalù, Principal Investigator
URL https://clinicaltrials.gov/ct2/show/NCT02135705 

 

Title Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, and the Role of Glasdegib as a Post-transplant Maintenance, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML
NCT Number NCT04168502
AML1819
Conditions  
Interventions Parallel Assignment
Sponsor/Collaborators  
Gender All
Age 18 Years to 60 Years   (Adult)
Phases III
Enrollment 414 participants
Study Type Interventional (Clinical Trial)
Study Designs

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Start Date 24/09/2020
Completion Date 01/04/2027
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra
URL https://clinicaltrials.gov/ct2/show/NCT04168502 

 

Title A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
NCT Number NCT05581303
AMG 20180244
Conditions Atherosclerotic Cardiovascular Disease
Interventions Parallel Assignment
Sponsor/Collaborators Amgen
Gender All
Age 18 Years to 85 Years   (Adult, Older Adult)
Phases Phase 3
Enrollment 6000 participants
Study Type Interventional  (Clinical Trial)
Study Designs

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Double (Participant, Investigator)

Primary Purpose: Treatment

Start Date 14/12/2022
Completion Date 16/12/2026
Locations

A.O.U. Policlinico P. Giaccone di Palermo, Prof. Angelo Baldassare Cefalù, Principal Investigator

URL

https://clinicaltrials.gov/ct2/show/NCT05581303 

https://www.amgentrials.com/study/?id=20180244 

 

Title Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double- Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies
NCT Number 2021-005092-39 (EudraCT)
Conditions atherosclerotic cardiovascular disease (ASCVD)
Interventions  
Sponsor/Collaborators NewAmsterdam Pharma B.V.
Gender All
Age 18 years of age at Screening (Visit 1)
Phases Phase 3
Enrollment 9000 participants
Study Type Therapeutic confirmatory (Phase III)
Study Designs Controlled
Randomised
Double blind
Start Date 12/04/2022
Completion Date 07/12/2026
Locations

A.O.U. Policlinico P. Giaccone di Palermo, Prof. Angelo Baldassare Cefalù, Principal Investigator

URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005092-39/IT 

 

Title Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
NCT Number

NCT04867915

CLL2121

Conditions Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type
Interventions  
Sponsor/Collaborators Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender All
Age 18 Years and older   (Adult, Older Adult)
Phases  
Enrollment 12500 participants
Study Type Observational
Study Designs Case-Only
Start Date 13/10/2021
Completion Date 31/10/2026
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrials.gov/ct2/show/NCT04867915 

 

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

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

  

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

 

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

Studio interventistico di fase II, prospettico, multicentrico, in pazienti affetti da leucemia mieloide acuta secondaria a neoplasie mieloproliferative non eleggibili per chemioterapia intensiva, per valutare una terapia di combinazione con decitabina e venetoclax.
EudraCT number 2020-006114-20
AML2420; ENABLE
Medical condition

Acute Myeloid Leukemia secondary to myeloproliferative neoplasms
Leucemia Mieloide Acuta secondaria a neoplasie mieloproliferative

Interventions  
Sponsor Name FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 101
Trial type Therapeutic exploratory (Phase II)
Design of the trial Controlled; Open; 
Start Date 17/09/2021
Completion Date 15/03/2026
Locations Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006114-20/IT 

 

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

Studio di fase 1b/2 in aperto, multicentrico per valutare la sicurezza e l’efficacia di KRT-232 in combinazione con ruxolitinib in pazienti con mielofibrosi primaria (PMF), MF post-policitemia vera (Post-PV-MF) o MF post-trombocitemia essenziale (Post-ET-MF) che rispondono a ruxolitinib in maniera subottimale
EudraCT number

2019-004554-29

NCT04485260

KRT-232-109

Medical condition Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF)

Mielofibrosi primaria (PMF), Post – Policitemia Vera MF (Post – PV-MF) o Trombocitemia post-essenziale MF (Post-ET-MF)
Interventions  
Sponsor Name Kartos Therapeutics, Inc
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 78
Trial type Therapeutic exploratory (Phase II)
Design of the trial Sicurezza ed efficacia di KRT-232 con Ruxolitinib nei pazienti con PMF, Post – PV-MF, Post-ET-MF
Safety and Efficacy of KRT-232 with Ruxolitinib in Patients with PMF, Post–PV-MF, Post-ET-MF
Start Date 11/03/2020
Completion Date 10/03/2026
Locations United States
Italy: A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL

https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004554-29/IT

https://www.clinicaltrials.gov/ct2/show/NCT04485260 

 

Title HoFH, the International Clinical Collaborators - A Global HoFH Data-sharing Platform
NCT Number NCT04815005
HICC
Conditions Homozygous Familial Hypercholesterolemia
Interventions Parallel Assignment
Sponsor/Collaborators University of Pennsylvania
Gender All
Age Child, Adult, Older Adult
Phases  
Enrollment 1000 participants
Study Type Observational [Patient Registry]
Study Designs

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Double (Participant, Investigator)

Primary Purpose: Treatment

Start Date 24/01/2017
Completion Date 31/12/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, Prof. Maurizio Averna, Prof. Angelo Baldassare Cefalù
URL

https://clinicaltrials.gov/ct2/show/NCT04815005

https://www.centerwatch.com/clinical-trials/listings/270143/hofh-the-international-clinical-collaborators-registry/   

 

Title ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
NCT Number NCT03301506
CB8025-31731
Prot. Cb8025-31731-Re ­
Codice Eudract: 2020-005198-29
Conditions  
Interventions Parallel Assignment
Sponsor/Collaborators CymaBay Therapeutics, Inc.
Gender All
Age 18 Years to 75 Years   (Adult, Older Adult)
Phases  
Enrollment 500 participants
Study Type Interventional
                 (Clinical Trial)
Study Designs

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

Start Date 12/12/2017
Completion Date 01/12/2025
Locations

Sperimentatore: Prof.ssa V. Calvaruso;
Centro: U.O.C. di Gastroenterologia ed Epatologia A.O.U. Policlinico P. Giaccone di Palermo;
Promotore: CymaBay Therapeutics, Inc.
CRO: PPD Italy s.r.l.

URL https://clinicaltrials.gov/ct2/show/NCT03301506 

 

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

 

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

 

Title An Open-Label Extension Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
NCT Number NCT05130450 - (EudraCT Number: 2021-003280-95)
Conditions Familial Chylomicronemia Syndrome
Interventions Drug: Olezarsen
Sponsor/Collaborators Ionis Pharmaceuticals, Inc.
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases Phase 3
Enrollment 60
Study Type Interventional
Study Designs Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Start Date 18/11/2021
Completion Date 30/04/2025
Locations

Italy
UOC di Farmacia AOUP PAOLO GIACCONE - Palermo, Italy, 90127 

Prof. Angelo Baldassare Cefalù, Principal Investigator 

and other 11 international study locations

URL https://ClinicalTrials.gov/show/NCT04568434 

 

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

NCT05621746

NN7088-4928

Conditions Intervention/treatment 

Haemophilia A

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

 

Title Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy: An Observational Prospective Study Of The Fondazione Italiana Linfomi
NCT Number

NCT05524298

FIL_QoL-ELDIND

Conditions Low Grade Non-Hodgkin's Lymphoma, Adult
Interventions  
Sponsor/Collaborators Fondazione Italiana Linfomi ONLUS
Gender All
Age 70 Years and older   (Older Adult)
Phases  
Enrollment 150 participants
Study Type Observational
Study Designs Cohort
Start Date 01/09/2022
Completion Date 01/02/2025
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Dott.ssa Salvatrice Mancuso
URL https://www.clinicaltrials.gov/ct2/show/NCT05524298 

 

Title A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
NCT Number NCT05079919 - (EudraCT Number: 2021-002192-19)
Conditions Severe Hypertriglyceridemia
Interventions Drug: Olezarsen
Drug: Placebo
Sponsor/Collaborators Ionis Pharmaceuticals, Inc.
Gender All
Age 18 Years and older (Adult, Older Adult)
Phases Phase 3
Enrollment 540
Study Type Interventional
Study Designs Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Start Date 25/10/2021
Completion Date 28/02/2025
Locations

Italy
Ospdale E. Bassini - Milano, Italy, 20092
A.O. Policlinico Universitario P. Giaccone - Palermo, Italy, 90127
Policlinico Umberto - Roma, Italy, 00161 

and other 94 international study locations

URL https://ClinicalTrials.gov/show/NCT05079919 

 

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

Haematologic Disease

Haematological Malignancy

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

 

Title 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/Collaborators 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 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
Medical condition Hemophilia A or B

Emofilia A o B
Interventions  
Sponsor/Collaborators PFIZER INC
Gender Male
Population Age Adolescents (12-17 years); Adults; Elderly; 
Phases Phase III
Enrollment 145
Trial type Therapeutic confirmatory (Phase III)
Design of the trial 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

 

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

Medical condition Patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma

Pazienti con Linfoma Diffuso a Grandi Cellule B ricaduto o refrattario
Interventions  
Sponsor/Collaborators FONDAZIONE ITALIANA LINFOMI ONLUS
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 81
Trial type Therapeutic exploratory (Phase II)
Design of the trial 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/Collaborators 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

A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

Studio di fase 3, randomizzato, in doppio cieco, con controllo attivo di CPI-0610 e Ruxolitinib rispetto a placebo e Ruxolitinib nei pazienti con MF naïve al trattamento con JAKi

EudraCT number

2020-001989-10

MANIFEST-2

Medical condition Myelofibrosis

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

Crossover is possible for control arm after double-blind treatment
Start Date 02/11/2021
Completion Date 29/07/2024
Locations United States - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott. Marco Santoro
URL https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001989-10/IT 

 

Title 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/Collaborators 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 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
Medical condition Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia (AML)
Interventions  
Sponsor Name Arog Pharmaceuticals, Inc.
Gender Male, Female
Population Age Adults, Elderly
Phases III
Enrollment 322
Trial type Therapeutic confirmatory (Phase III)
Design of the trial 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/Collaborators GlaxoSmithKline
Gender All
Age 60 Years and older   (Adult, Older Adult)
Phases  
Enrollment 5000 participants
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 

 

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/Collaborators Antonino Tuttolomondo, University professor of Palermo
Gender All
Age 18 Years to 90 Years   (Adult, Older Adult)
Phases Phase 4
Enrollment 5000 participants
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 

 

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/Collaborators 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/Collaborators 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/Collaborators 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

Medical condition Higher-risk-myelodysplastic syndromes

Sindrome mielodisplastica ad alto rischio
Interventions  
Sponsor/Collaborators FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 274
Trial type Therapeutic confirmatory (Phase III)
Design of the trial Controlled; Randomised; Open; Parallel group; 
Start Date 06/10/2020
Completion Date 01/03/2024
Locations A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL

https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003997-25/IT

https://www.clinicaltrials.gov/ct2/show/NCT04184505 

 

Title Epidemiology of COVID-19 Infection in Patients With Hematological Malignancies: A European Haematology Association Survey
NCT Number NCT04733729
Conditions COVID-19 Infection in Hematological Malignancies Patients
Interventions  
Sponsor/Collaborators 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 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

Medical condition Myelofibrosis

Mielofibrosi
Interventions  
Sponsor Name KARYOPHARM THERAPEUTICS, INC.
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase II
Enrollment 112
Trial type Therapeutic exploratory (Phase II)
Design of the trial 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
Population 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 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/Collaborators 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/Collaborators 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 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/Collaborators 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/Collaborators 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 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
Medical condition Primary Immune Thrombocytopenia

Trombocitopenia immune primaria
Interventions  
Sponsor/Collaborators UCB Biopharma SRL
Gender Female; Male
Population Age Adults; Elderly; 
Phases Phase III
Enrollment 210
Trial 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 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/Collaborators 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/Collaborators 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 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/Collaborators 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/Collaborators 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/Collaborators 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 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/Collaborators 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 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/Collaborators 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