Ascolta

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

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

[#TOT Trial in corso: 92]

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

 

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

 

Title	A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib,Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide Uno studio randomizzato di fase 3 che confronta Teclistamab in monoterapia con pomalidomide, bortezomib, desametasone (PVd) o carfilzomib, desametasone (Kd) in partecipanti con mieloma multiplo recidivante o refrattario che hanno ricevuto da 1 a 3 linee terapeutiche precedenti, incluso un anticorpo monoclonale anti-CD38 e lenalidomide
EudraCT number	2022-000928-37 6400795MMY3006
Medical condition	Multiple myeloma Mieloma multiplo
Interventions
Sponsor	JANSSEN CILAG INTERNATIONAL NV
Gender	Female; Male
Population Age	Adults; Elderly;
Phases	Phase III
Enrollment	590
Trial type	Therapeutic confirmatory (Phase III)
Design of the trial	Controlled; Randomised; Open;
Start Date	02/09/2023
Completion Date	31/08/2031
Locations	A.O.U. Policlinico P. Giaccone Palermo, Dott. Cirino Botta, U.O.C. di Ematologia
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000928-37/IT

 

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

   

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

  

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

 

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

 

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

 

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

 

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

 

 

 

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

 

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

 

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

 

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

 

Title	The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular disease Sicurezza cardiovascolare di cagrilintide 2,4 mg in combinazione con semaglutide 2,4 mg (CagriSema 2,4 mg/2,4 mg) da assumere per via sottocutanea una volta alla settimana in partecipanti con obesità e malattia cardiovascolare accertata
EudraCT number	2021-005855-35
Conditions	Atherosclerotic cardiovascular disease and Obesity Malattia cardiovascolare aterosclerotica e obesità
Interventions
Sponsor	NOVO NORDISK. S.P.A.
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	4000
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Randomised; Parallel group;
Start Date	01/10/2023
Completion Date	29/11/2027
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005855-35/IT

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Title	Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes (EQoL-MDS)
NCT Number	NCT02912208
Conditions	Myelodysplastic Syndromes Thrombocytopenia
Interventions
Sponsor	Associazione Qol-one
Gender	All
Age	18 Years and older   (Adult, Older Adult)
Phases	Phase 2
Enrollment	174 participants
Study Type	Interventional  (Clinical Trial)
Study Designs	Parallel Assignment
Start Date	11/06/2011
Completion Date	31/10/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrials.gov/ct2/show/NCT02912208

 

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

 

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

 

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

 

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

 

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

 

Title	A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 versus Best Available Therapy in Subjects with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Count <50,000/µL) Studio di Fase 2b, in aperto, multicentrico, randomizzato, controllato, a 2 bracci per valutare l’efficacia e la sicurezza di NS-018 somministrato per via orale rispetto alla migliore terapia disponibile in soggetti con mielofibrosi primaria, mielofibrosi post-policitemia vera o mielofibrosi post-trombocitemia essenziale con trombocitopenia grave (conta piastrinica <50.000/µl)
EudraCT number	2021-000369-34 NS-018-201
Medical condition	Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia Mielofibrosi primaria, mielofibrosi post-policitemia vera o mielofibrosi posttrombocitemia essenziale con grave trombocitopenia
Interventions
Sponsor/Collaborators	NS Pharma, Inc, IQVIA Biotech
Gender	Female; Male
Population Age	Adults; Elderly;
Phases	Phase II
Enrollment	120
Trial type	Therapeutic exploratory (Phase II)
Design of the trial	Controlled; Randomised; Open;
Start Date	02/07/2023
Completion Date	01/07/2026
Locations	A.O.U. Policlinico P. Giaccone Palermo, Prof. Sergio Siragusa U.O.C. di Ematologia
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000369-34/IT

 

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

 

Title	A Phase 2, prospective, multi-center intervention trial in patients with acute myeloid leukemia secondary to myeloproliferative neoplasms unfit for intensive chemotherapy investigating a treatment combination including decitabine and venetoclax. ENABLE (vENetoclax plus decitAbine treatment in Blastic phase of myeLoproliferative nEoplasms) Studio interventistico di fase II, prospettico, multicentrico, in pazienti affetti da leucemia mieloide acuta secondaria a neoplasie mieloproliferative non eleggibili per chemioterapia intensiva, per valutare una terapia di combinazione con decitabina e venetoclax.
EudraCT number	2020-006114-20 AML2420; ENABLE
Conditions	Acute Myeloid Leukemia secondary to myeloproliferative neoplasms Leucemia Mieloide Acuta secondaria a neoplasie mieloproliferative
Interventions
Sponsor Name	FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	101
Study Type	Therapeutic exploratory (Phase II)
Study Designs	Controlled; Open;
Start Date	17/09/2021
Completion Date	15/03/2026
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006114-20/IT

 

Title	An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib Studio di fase 1b/2 in aperto, multicentrico per valutare la sicurezza e l’efficacia di KRT-232 in combinazione con ruxolitinib in pazienti con mielofibrosi primaria (PMF), MF post-policitemia vera (Post-PV-MF) o MF post-trombocitemia essenziale (Post-ET-MF) che rispondono a ruxolitinib in maniera subottimale
EudraCT number	2019-004554-29 NCT04485260 KRT-232-109
Conditions	Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Mielofibrosi primaria (PMF), Post – Policitemia Vera MF (Post – PV-MF) o Trombocitemia post-essenziale MF (Post-ET-MF)
Interventions
Sponsor Name	Kartos Therapeutics, Inc
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	78
Study Type	Therapeutic exploratory (Phase II)
Study Designs	Sicurezza ed efficacia di KRT-232 con Ruxolitinib nei pazienti con PMF, Post – PV-MF, Post-ET-MF Safety and Efficacy of KRT-232 with Ruxolitinib in Patients with PMF, Post–PV-MF, Post-ET-MF
Start Date	11/03/2020
Completion Date	10/03/2026
Locations	United States Italy: A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004554-29/IT https://www.clinicaltrials.gov/ct2/show/NCT04485260

 

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

  

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

 

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

 

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

 

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

 

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

  

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

 

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

 

Title	A Randomised, Double-blind, Placebo-Controlled, Multi-Center Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele Studio di fase IIb randomizzato, multicentrico, in doppio cieco, controllato con placebo volto a valutare l’efficacia, la sicurezza e la tollerabilità di AZD2693 in pazienti affetti da steatoepatite non alcolica non cirrotica (NASH) con fibrosi e portatori dell’allele di rischio di PNPLA3 rs738409 148M
EudraCT number	2022-001629-65 D7830C00004
Medical condition	Non-cirrhotic non-alcoholic steatohepatitis with fibrosis Steatoepatite non alcolica non cirrotica con fibrosi
Interventions
Sponsor/Collaborators	ASTRAZENECA AB
Gender	Female; Male
Population Age	Adults; Elderly;
Phases	Phase II
Enrollment	318
Trial type	Therapeutic exploratory (Phase II)
Design of the trial	Controlled; Randomised; Parallel group;
Start Date	13/03/2023
Completion Date	08/10/2025
Locations	A.O.U. Policlinico P. Giaccone Palermo, Prof. Salvatore Petta, U.O.C. di Gastroenterologia
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-001629-65/IT

 

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

 

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

 

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

 

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

 

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

 

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

 

Title	17 beta-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with Pre-Cirrhotic Non-Alcoholic Steatohepatitis Studio in doppio cieco, controllato verso placebo, di Fase 2b per valutare l’efficacia e la sicurezza di GSK4532990 in adulti con steatoepatite pre-cirrotica non alcolica (Non-Alcoholic Steatohepatitis – NASH)
EudraCT number	2022-002538-14 218672
Medical condition	Nonalcoholic steatohepatitis (NASH) Steatoepatite pre-cirrotica non alcolica (NASH)
Interventions
Sponsor/Collaborators	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
Gender	Female; Male
Population Age	Adults; Elderly;
Phases	Phase II
Enrollment	246
Trial type	Therapeutic exploratory (Phase II)
Design of the trial	Controlled; Randomised; Parallel group;
Start Date	27/01/2023
Completion Date	25/02/2025
Locations	A.O.U. Policlinico P. Giaccone Palermo, Prof. Salvatore Petta, U.O.C. di Gastroenterologia
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002538-14/IT

 

Title	Non-Interventional Study of the Change in Joint Health in Adult Patients With Haemophilia A After Switching to Prophylaxis With Turoctocog Alfa Pegol (N8-GP)
NCT Number	NCT05621746 NN7088-4928
Conditions	Intervention/treatment  Haemophilia A Drug: Esperoct
Interventions
Sponsor	Novo Nordisk A/S
Gender	Male
Age	18 Years and older   (Adult, Older Adult)
Phases
Enrollment	100 participants
Study Type	Observational
Study Designs	Cohort
Start Date	23/11/2022
Completion Date	14/02/2025
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Ematologia, prof.ssa Mariasanta Napolitano
URL	https://www.clinicaltrials.gov/ct2/show/NCT05621746

 

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

 

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

 

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

 

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

  

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

 

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

  

Title	Potential Role of Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Ascites in Cirrhotic Patients
NCT Number	NCT05999773
Conditions	Intervention/treatment  Ascites Hepatic Cirrhosis, Liver Diabete Type 2
Interventions	Drug: SGLT2 inhibitor
Sponsor
Gender	All
Age	18 Years to 80 Years   (Adult, Older Adult)
Phases
Enrollment	40 participants
Study Type	Observational
Study Designs	Case-Control
Start Date	15/06/2023
Completion Date	31/12/2024
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Lydia Giannitrapani, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Aurelio Seidita
URL	https://www.clinicaltrials.gov/ct2/show/NCT05999773

 

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

  

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

 

Title	A Multicentre, Prospective, Non-Interventional, Single-Arm Study Investigating Glycaemic Control and Patient-Reported Outcomes in Type 2 Diabetes Patients, Uncontrolled on DPP4i Treatment and Who Switch to Oral Semaglutide in a Real-World Setting in Italy
NCT Number	NCT05755360 NN9924-7508 U1111-1274-4674 ( Other Identifier ) (OTHER: World Health Organization (WHO))
Conditions	Intervention/treatment  Diabetes Mellitus, Type 2 Drug: Semaglutide
Interventions
Sponsor/Collaborators	Novo Nordisk A/S
Gender	All
Age	18 Years and older   (Adult, Older Adult)
Phases
Enrollment	390 participants
Study Type	Observational
Study Designs	Cohort
Start Date	21/02/2023
Completion Date	31/10/2024
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Prof. Mario Barbagallo, U.O.C. di Geriatria
URL	https://www.clinicaltrials.gov/ct2/show/NCT05755360

 

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

 

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

 

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

  

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

 

Title	An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis Studio in aperto in pazienti adolescenti e adulti affetti da grave emofilia A o B (attività del fattore di coagulazione <1%) con o senza inibitori volto a confrontare la terapia standard con la profilassi con PF-06741086
EudraCT number	2018-003660-31 NCT03938792
Conditions	Hemophilia A or B Emofilia A o B
Interventions
Sponsor	PFIZER INC
Gender	Male
Age	Adolescents (12-17 years); Adults; Elderly;
Phases	Phase III
Enrollment	145
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Open; Unidirezionale One way
Start Date	24/09/2020
Completion Date	27/09/2024
Locations	United States - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003660-31/IT  https://www.clinicaltrials.gov/ct2/show/NCT03938792

 

Title	Copanlisib in combination with Rituximab-Bendamustine in patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma: a multicentric Phase II trial Copanlisib in combinazione con Rituximab e Bendamustina per il trattamento di pazienti con Linfoma Diffuso a Grandi Cellule B ricaduto o refrattario: studio multicentrico di fase II
EudraCT number	2019-004898-63 FIL COPA RB
Conditions	Patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma Pazienti con Linfoma Diffuso a Grandi Cellule B ricaduto o refrattario
Interventions
Sponsor	FONDAZIONE ITALIANA LINFOMI ONLUS
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	81
Study Type	Therapeutic exploratory (Phase II)
Study Designs	Studio di fase II, braccio singolo, in aperto Phase II, single arm, open label clinical trial
Start Date	18/08/2020
Completion Date	17/08/2024
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott.ssa Salvatrice Mancuso
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004898-63/IT

 

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

 

Title	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
Conditions	Myelofibrosis Mielofibrosi
Interventions
Sponsor Name	Constellation Pharmaceuticals, Inc.
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	310
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Randomised; Parallel group; Il crossover è possibile per il braccio di controllo dopo il trattamento in doppio cieco Crossover is possible for control arm after double-blind treatment
Start Date	02/11/2021
Completion Date	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	Novo Nordisk A/S
Gender	All
Age	50 Years and older   (Adult, Older Adult)
Phases	Phase 3
Enrollment	9642 participants
Study Type	Interventional  (Clinical Trial)
Study Designs	Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Start Date	17/06/2019
Completion Date	29/07/2024
Locations	A.O.U. Policlinico P. Giaccone di Palermo
URL	https://clinicaltrials.gov/ct2/show/NCT03914326

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Title	A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogrens Syndrome (pSS) Studio multicentrico, randomizzato, controllato con placebo, in doppio cieco per valutare l’efficacia e la sicurezza di nipocalimab in adulti affetti da sindrome di Sjogrens primaria (SSp)
EudraCT number	2021-000665-32
Conditions	Primary Sjogrens Syndrome sindrome di Sjogrens primaria
Interventions
Sponsor	JANSSEN CILAG INTERNATIONAL NV
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	150
Study Type	Therapeutic exploratory (Phase II)
Study Designs	Controlled; Randomised; Parallel group;
Start Date	11/10/2021
Completion Date	08/05/2024
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000665-32/IT

 

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

 

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

 

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

 

Title	A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS)
NCT Number	NCT04460950 AML2120
Conditions	Acute Myeloid Leukemia Familial Acute Myeloid Leukemia Myelodysplastic Syndromes
Interventions
Sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender	All
Age	18 Years and older   (Adult, Older Adult)
Phases
Enrollment	237 participants
Study Type	Observational
Study Designs	Case-Only
Start Date	16/12/2020
Completion Date	31/03/2024
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra
URL	https://www.clinicaltrials.gov/ct2/show/NCT04460950

 

Title	Prospective randomized study on the feasibility of allogeneic stem cell transplantation in higher-risk-myelodysplastic syndromes, performed upfront or preceded by azacitidine or conventional chemotherapy, according to the BM-blast proportion (ACROBAT trial) Studio randomizzato, prospettico, sulla fattibilità del trapianto allogenico di cellule staminali in pazienti affetti da Sindrome mielodisplastica ad alto rischio, eseguito upfront o preceduto da azacitidina o chemioterapia convenzionale, secondo la percentuale di blasti midollari
EudraCT number	2019-003997-25 NCT04184505
Conditions	Higher-risk-myelodysplastic syndromes Sindrome mielodisplastica ad alto rischio
Interventions
Sponsor	FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	274
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Randomised; Open; Parallel group;
Start Date	06/10/2020
Completion Date	01/03/2024
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003997-25/IT https://www.clinicaltrials.gov/ct2/show/NCT04184505

 

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

 

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

 

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

 

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

 

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

 

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

 

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

  

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

 

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

 

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