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

Studi Clinici Osservazionali

Progetti intradipartimentali approvati dal Comitato Etico

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

Trial in corso

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