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 |
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 |
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 |
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 |
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 |
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; |
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 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 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 |
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 |
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 |
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 |
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
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 and other 607 international study locations |
URL |
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 |