[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06093672":3,"trial-entities:NCT06093672":809,"trial-summary:NCT06093672":812},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":42,"secondary_outcomes":47,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":94,"locations":97,"central_contacts":801,"overall_officials":806,"references":807,"see_also_links":808},"NCT06093672","DSC\u002F08\u002F2357\u002F32","Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera","Randomized, Open-label, Multicenter Phase 3 Study to Assess the Efficacy and Safety of GIVinostat Versus Hydroxyurea IN JAK2V617F-positive High-risk Polycythemia Vera Patients: the GIV-IN PV TRIAL","RECRUITING","2026-07","2026-03","2026-03-25","2024-03-26","Italfarmaco","INDUSTRY",true,"The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.","PV is a cMPN mainly driven by JAK2V617F mutation. The disease has an increased risk of thromboembolic complications, a predisposition to evolve into myelofibrosis (MF) and transformation into acute myeloid leukemia.\n\nPatients ≥ 60 years of age and\u002For with a previous thrombotic event (TE) are considered at High Risk (HR) for thrombosis. The association of absolute values of circulating neutrophil, lymphocyte and monocyte and the high value of JAK2V617F allele burden are additional risk factors for the occurrence of thrombosis and for progression to MF, respectively.\n\nOverall, most patients treated with HU are not adequately under control for both symptoms and long-term risks.\n\nIn recent years, data have shown that histone deacetylase (HDACs) inhibitors induce growth arrest, differentiation, and\u002For apoptosis in neoplastic cells. Givinostat has demonstrated preliminary signs of clinical activity and an acceptable safety profile in patients with JAK2V617F-positive cMPNs in three phase 2 studies.\n\nThe core treatment phase (pivotal phase 3 study) is designed to demonstrate the superiority of givinostat versus HU on efficacy, in JAK2V617F-positive, HR PV patients.\n\nThe extended treatment phase will allow eligible patients to receive givinostat in the long-term, with the objective of collecting long-term safety and efficacy data.",[19],"Polycythemia Vera",[19,21],"Givinostat","INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},220,"ESTIMATED",[30,37],{"type":31,"name":21,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.",[34],"Givinostat - Core phase",[36],"ITF2357",{"type":31,"name":38,"description":32,"armGroupLabels":39,"otherNames":41},"Hydroxyurea",[40],"Hydroxyurea - Core phase",[36],[43],{"measure":44,"description":45,"timeFrame":46},"Proportion of patients achieving a response at Week 48.","Response assessment based on:\n\n* Hematocrit \\\u003C 45% without phlebotomy in the prior 3 months, and\n* White blood cell (WBC) count ≤ 10 × 109\u002FL, and\n* Platelet count ≤ 400 × 109\u002FL, and\n* Normal spleen size as measured by imaging (normal spleen size is defined as: a longitudinal diameter ≤ 12 cm for female and ≤ 13 cm for male) and\n* During Part 2 (Week 25 to 48), absence of progressive disease, major hemorrhagic events and major thrombotic events.","week 25 - week 48",[48,52,55,57],{"measure":49,"description":50,"timeFrame":51},"Proportion of patients achieving a complete hematological response (CHR) at Week 48.","CHR based on:\n\n* Hematocrit \\\u003C 45% without phlebotomy in the prior 3 months, and\n* White blood cell (WBC) count ≤ 10 × 109\u002FL, and\n* Platelet count ≤ 400 × 109\u002FL","week 48",{"measure":53,"timeFrame":54},"Time from randomization to the first observed CHR","Randomization - week 48",{"measure":56,"timeFrame":51},"Proportion of patients with a normal spleen size at Week 48.",{"measure":58,"timeFrame":54},"Safety and tolerability up to Week 48.","ALL","18 Years",null,false,{"inclusion":64,"exclusion":76,"raw_text":93},[65,66,67,68,69,70,71,72,73,74,75],"Patients must have been diagnosed with PV according to the 2016 WHO criteria before randomization","Patients must have JAK2V617F-positive disease","Patients with PV must meet the definition of HR for thrombosis (i.e., HR) within 3 years before screening as follows:","Age ≥ 60 years, and\u002For","Prior thrombosis.","Patients must be in need of treatment at screening, defined by the presence of at least one of the following:","HCT ≥ 45% or HCT \\\u003C 45% with at least 1 phlebotomy performed in the 3 months before screening, or","WBC count \\> 10 × 109\u002FL, or","PLT count \\> 400 × 109\u002FL.","Patients must have normalized HCT (i.e., HCT \\\u003C 45%) at randomization","Patients must have completed the Week 48 visit of the DSC\u002F08\u002F2357\u002F32 core treatment phase and:",[77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92],"Patients pre-treated with HU with a documented history of resistance or intolerance to HU defined by the original ELN criteria","Patients with a QTcF value of \\> 450 msec for males and \\> 460 msec for females at the Screening visit (as the mean of 3 consecutive readings 5 minutes apart in the event a first ECG demonstrates a prolonged QTcF interval); congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit","Splanchnic thrombosis and\u002For thrombosis of the cerebral venous sinuses and\u002For splenectomy in the medical history","Patients with clinically significant cardiovascular disease","Patients with myocardial infarction, stroke or unstable angina within the 6 months prior to screening.","Patients with inadequate liver or renal function at screening","Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 × ULN","Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.","Patients being treated concurrently with any investigational agent or prior participation in an interventional clinical study within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer.","Pregnant or nursing women","For patients randomized to givinostat in the core treatment phase - Patients with a QTcF value at Week 48 of \\> 500 msec","For patients randomized to HU in the core treatment phase:","PLT count ≤ 150 × 109\u002FL at Week 48","ANC \\\u003C 1.2 × 109\u002FL at Week 48","Uncontrolled hypertriglyceridemia at Week 48","Patients with a QTcF value at Week 48 of \\> 450 msec for males and \\> 460 msec for female","Core Treatment - Inclusion Criteria:\n\n* Patients must have been diagnosed with PV according to the 2016 WHO criteria before randomization\n* Patients must have JAK2V617F-positive disease\n* Patients with PV must meet the definition of HR for thrombosis (i.e., HR) within 3 years before screening as follows:\n\n  * Age ≥ 60 years, and\u002For\n  * Prior thrombosis.\n* Patients must be in need of treatment at screening, defined by the presence of at least one of the following:\n\n  * HCT ≥ 45% or HCT \\\u003C 45% with at least 1 phlebotomy performed in the 3 months before screening, or\n  * WBC count \\> 10 × 109\u002FL, or\n  * PLT count \\> 400 × 109\u002FL.\n* Patients must have normalized HCT (i.e., HCT \\\u003C 45%) at randomization\n\nExtended Treatment - Inclusion Criteria\n\n* Patients must have completed the Week 48 visit of the DSC\u002F08\u002F2357\u002F32 core treatment phase and:\n\n  1. if the patient received givinostat, a complete hematological response (CHR) at Week 48 shall be achieved\n  2. if the patient received HU, did not achieve a CHR (see above for the definition) at Week 48\n\n     Core Treatment phase - Exclusion Criteria\n* Patients pre-treated with HU with a documented history of resistance or intolerance to HU defined by the original ELN criteria\n* Patients with a QTcF value of \\> 450 msec for males and \\> 460 msec for females at the Screening visit (as the mean of 3 consecutive readings 5 minutes apart in the event a first ECG demonstrates a prolonged QTcF interval); congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit\n* Splanchnic thrombosis and\u002For thrombosis of the cerebral venous sinuses and\u002For splenectomy in the medical history\n* Patients with clinically significant cardiovascular disease\n* Patients with myocardial infarction, stroke or unstable angina within the 6 months prior to screening.\n* Patients with inadequate liver or renal function at screening\n* Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 × ULN\n* Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.\n* Patients being treated concurrently with any investigational agent or prior participation in an interventional clinical study within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer.\n* Pregnant or nursing women\n\nExtended treatment phase - Exclusion criteria\n\n* For patients randomized to givinostat in the core treatment phase - Patients with a QTcF value at Week 48 of \\> 500 msec\n* For patients randomized to HU in the core treatment phase:\n\n  * PLT count ≤ 150 × 109\u002FL at Week 48\n  * ANC \\\u003C 1.2 × 109\u002FL at Week 48\n  * Uncontrolled hypertriglyceridemia at Week 48\n  * Patients with a QTcF value at Week 48 of \\> 450 msec for males and \\> 460 msec for female",[95,96],"ADULT","OLDER_ADULT",[98,108,116,124,136,143,151,159,167,175,179,190,198,206,214,223,231,239,246,255,262,269,278,285,288,295,304,312,319,327,335,343,351,358,366,375,383,392,399,408,416,424,431,438,442,451,458,465,469,481,489,497,504,511,519,527,538,545,553,560,567,575,582,590,598,607,615,623,631,638,645,653,656,659,666,673,682,689,696,703,710,719,729,740,751,759,769,776,786,792],{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"University of Alabama at Birmingham","NOT_YET_RECRUITING","Birmingham","Alabama","35294-0001","United States",{"lat":106,"lon":107},33.52066,-86.80249,{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":104,"geoPoint":113},"Emad Ibrahim, MD, Inc","Redlands","California","92373",{"lat":114,"lon":115},34.05557,-117.18254,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":104,"geoPoint":121},"US Oncology Inc","Englewood","Colorado","80113",{"lat":122,"lon":123},39.64777,-104.98776,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":104,"contacts":129,"geoPoint":133},"American Oncology Partners of Maryland, PA","Bethesda","Maryland","20852",[130],{"name":131,"role":132},"Victor Priego","CONTACT",{"lat":134,"lon":135},38.98067,-77.10026,{"facility":137,"status":8,"city":138,"state":138,"zip":139,"country":104,"geoPoint":140},"Icahn School of Medicine at Mount Sinai","New York","10029",{"lat":141,"lon":142},40.71427,-74.00597,{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":104,"geoPoint":148},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"lat":149,"lon":150},35.9132,-79.05584,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":104,"geoPoint":156},"The Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"lat":157,"lon":158},41.4995,-81.69541,{"facility":160,"status":8,"city":161,"state":162,"zip":163,"country":104,"geoPoint":164},"Oncology Associates of Oregon, P.C.","Eugene","Oregon","97401",{"lat":165,"lon":166},44.05207,-123.08675,{"facility":168,"status":8,"city":169,"state":170,"zip":171,"country":104,"geoPoint":172},"MD Anderson Cancer Center","Houston","Texas","77030",{"lat":173,"lon":174},29.76328,-95.36327,{"facility":176,"status":8,"city":169,"state":170,"zip":177,"country":104,"geoPoint":178},"Texas Oncology (Webster) - USOR","77089",{"lat":173,"lon":174},{"facility":180,"status":8,"city":181,"state":170,"zip":182,"country":104,"contacts":183,"geoPoint":187},"Texas Oncology-Denison Cancer Center","Sherman","75090",[184],{"name":185,"role":186},"Amir Faridi","PRINCIPAL_INVESTIGATOR",{"lat":188,"lon":189},33.63566,-96.60888,{"facility":191,"status":8,"city":192,"state":193,"zip":194,"country":104,"geoPoint":195},"University of Utah - Huntsman Cancer Institute - PPDS","Salt Lake City","Utah","84112",{"lat":196,"lon":197},40.76078,-111.89105,{"facility":199,"status":8,"city":200,"state":201,"zip":202,"country":104,"geoPoint":203},"The James Cancer Hospital and Solove Research Institute","Roanoke","Virginia","43210",{"lat":204,"lon":205},37.27097,-79.94143,{"facility":207,"status":8,"city":208,"state":209,"zip":210,"country":104,"geoPoint":211},"VA Puget Sound Health Care System - NAVREF - PPDS","Seattle","Washington","98108-1532",{"lat":212,"lon":213},47.60621,-122.33207,{"facility":215,"status":8,"city":216,"state":217,"zip":218,"country":219,"geoPoint":220},"Landesklinikum Wiener Neustadt","Wiener Neustadt","Lower Austria","2700","Austria",{"lat":221,"lon":222},47.80485,16.23196,{"facility":224,"status":8,"city":225,"state":226,"zip":227,"country":219,"geoPoint":228},"Medizinische Universitat Wien (Medical University of Vienna)","Vienna","State of Vienna","1090",{"lat":229,"lon":230},48.20849,16.37208,{"facility":232,"status":8,"city":233,"state":234,"zip":235,"country":219,"geoPoint":236},"Ordensklinikum Linz GmbH Elisabethinen","Linz","Upper Austria","4020",{"lat":237,"lon":238},48.30639,14.28611,{"facility":240,"status":8,"city":241,"state":234,"zip":242,"country":219,"geoPoint":243},"Klinikum Wels-Grieskirchen GmbH","Wels","4600",{"lat":244,"lon":245},48.16667,14.03333,{"facility":247,"status":8,"city":248,"state":249,"zip":250,"country":251,"geoPoint":252},"Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda","Sofia","Sofia-Grad","1407","Bulgaria",{"lat":253,"lon":254},42.69751,23.32415,{"facility":256,"status":8,"city":257,"zip":258,"country":251,"geoPoint":259},"University Multiprofile Hospital for Active Treatment Sveti Georgi EAD","Plovdiv","4001",{"lat":260,"lon":261},42.15387,24.75001,{"facility":263,"status":8,"city":264,"zip":265,"country":251,"geoPoint":266},"University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD","Stara Zagora","6003",{"lat":267,"lon":268},42.43205,25.64262,{"facility":270,"status":8,"city":271,"state":272,"zip":273,"country":274,"geoPoint":275},"Clinical Hospital Dubrava","Zagreb","City of Zagreb","10000","Croatia",{"lat":276,"lon":277},45.81444,15.97798,{"facility":279,"status":8,"city":280,"zip":281,"country":274,"geoPoint":282},"Clinical Hospital Center Rijeka - PPDS","Rijeka","51000",{"lat":283,"lon":284},45.32673,14.44241,{"facility":286,"status":100,"city":280,"zip":281,"country":274,"geoPoint":287},"Clinical Hospital Center Rijeka",{"lat":283,"lon":284},{"facility":289,"status":100,"city":290,"zip":291,"country":274,"geoPoint":292},"General Hospital Sibenik","Šibenik","22000",{"lat":293,"lon":294},43.73429,15.8942,{"facility":296,"status":8,"city":297,"state":298,"zip":299,"country":300,"geoPoint":301},"Centre Hospitalier de Saint-Quentin","Saint-Quentin","Aisne","2100","France",{"lat":302,"lon":303},49.84889,3.28757,{"facility":305,"status":8,"city":306,"state":307,"zip":308,"country":300,"geoPoint":309},"CHU de Nice","Nice","Alpes-Maritimes","6202",{"lat":310,"lon":311},43.70313,7.26608,{"facility":313,"status":8,"city":314,"state":315,"zip":273,"country":300,"geoPoint":316},"Centre Hospitalier de Troyes","Troyes","Aube",{"lat":317,"lon":318},48.30073,4.08524,{"facility":320,"status":8,"city":321,"state":322,"zip":323,"country":300,"geoPoint":324},"Hôpital Bretonneau","Tours","Indre-et-Loire","37044",{"lat":325,"lon":326},47.39484,0.70398,{"facility":328,"status":8,"city":329,"state":330,"zip":331,"country":300,"geoPoint":332},"CHU Nantes","Nantes","Loire-Atlantique","44000",{"lat":333,"lon":334},47.21725,-1.55336,{"facility":336,"status":8,"city":337,"state":338,"zip":339,"country":300,"geoPoint":340},"CHU Angers","Angers","Maine-et-Loire","49000",{"lat":341,"lon":342},47.47156,-0.55202,{"facility":344,"status":8,"city":345,"state":346,"zip":347,"country":300,"geoPoint":348},"CHU Amiens Hôpital Sud","Amiens","Somme","80054",{"lat":349,"lon":350},49.9,2.3,{"facility":352,"status":8,"city":353,"zip":354,"country":300,"geoPoint":355},"Hôpital Saint Louis","Paris","75010",{"lat":356,"lon":357},48.85341,2.3488,{"facility":359,"status":8,"city":360,"state":361,"zip":362,"country":300,"geoPoint":363},"Hopital d'Argenteuil","Argenteuil","Île-de-France Region","95107",{"lat":364,"lon":365},48.94788,2.24744,{"facility":367,"status":8,"city":368,"state":369,"zip":370,"country":371,"geoPoint":372},"Medizinische Fakultät Mannheim der Universität Heidelberg, Universitätsmedizin Mannheim","Mannheim","Baden-Wurttemberg","68167","Germany",{"lat":373,"lon":374},49.4891,8.46694,{"facility":376,"status":8,"city":377,"state":378,"zip":379,"country":371,"geoPoint":380},"Gemeinschaftspraxis Hämatologie - Onkologie","Dresden","Saxony","01307",{"lat":381,"lon":382},51.05089,13.73832,{"facility":384,"status":385,"city":386,"state":387,"zip":388,"country":371,"geoPoint":389},"Universitätsmedizin Halle, Universitätsklinikum Halle, Klinik für Innere Medizin IV","WITHDRAWN","Halle","Saxony-Anhalt","06120",{"lat":390,"lon":391},51.48158,11.97947,{"facility":393,"status":8,"city":394,"zip":395,"country":371,"geoPoint":396},"OncoResearch Lerchenfeld GmbH","Hamburg","22081",{"lat":397,"lon":398},53.55073,9.99302,{"facility":400,"status":8,"city":401,"state":402,"zip":403,"country":404,"geoPoint":405},"Gyor-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház","Győr","Győr-Moson-Sopron","9024","Hungary",{"lat":406,"lon":407},47.68333,17.63512,{"facility":409,"status":8,"city":410,"state":411,"zip":412,"country":404,"geoPoint":413},"Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház","Nyíregyháza","Szabolcs-Szatmár-Bereg","4400",{"lat":414,"lon":415},47.95539,21.71671,{"facility":417,"status":8,"city":418,"state":419,"zip":420,"country":404,"geoPoint":421},"Tolna Vármegyei Megyei Balassa János Kórház","Szekszárd","Tolna County","7100",{"lat":422,"lon":423},46.34723,18.71189,{"facility":425,"status":8,"city":426,"country":427,"geoPoint":428},"Cork University Hospital","Cork","Ireland",{"lat":429,"lon":430},51.89797,-8.47061,{"facility":432,"status":385,"city":433,"zip":434,"country":427,"geoPoint":435},"Connolly Hospital Blanchardstown","Dublin","15",{"lat":436,"lon":437},53.33306,-6.24889,{"facility":439,"status":8,"city":433,"zip":440,"country":427,"geoPoint":441},"Mater Misericordiae University Hospital","7",{"lat":436,"lon":437},{"facility":443,"status":444,"city":445,"state":445,"zip":446,"country":447,"geoPoint":448},"Hadassah Medical Center - PPDS","TERMINATED","Jerusalem","91120","Israel",{"lat":449,"lon":450},31.76904,35.21633,{"facility":452,"status":8,"city":453,"state":453,"zip":454,"country":447,"geoPoint":455},"Assuta Medical Center","Tel Aviv","60000",{"lat":456,"lon":457},32.08088,34.78057,{"facility":459,"status":444,"city":460,"zip":461,"country":447,"geoPoint":462},"Bnai Zion Medical Center","Haifa","31048",{"lat":463,"lon":464},32.81303,34.99928,{"facility":466,"status":444,"city":460,"zip":467,"country":447,"geoPoint":468},"Carmel Medical Center","34362",{"lat":463,"lon":464},{"facility":470,"status":8,"city":471,"state":472,"zip":473,"country":474,"contacts":475,"geoPoint":478},"Istituto Tumori \"Giovanni Paolo II\" I.R.C.C.S.","Bari","Apulia","70124","Italy",[476],{"name":477,"role":186},"Paolo Ditonno",{"lat":479,"lon":480},41.12066,16.86982,{"facility":482,"status":8,"city":483,"state":484,"zip":485,"country":474,"geoPoint":486},"Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli","Reggio Calabria","Calabria","89133",{"lat":487,"lon":488},38.11047,15.66129,{"facility":490,"status":8,"city":491,"state":492,"zip":493,"country":474,"geoPoint":494},"Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico","Bologna","Emilia-Romagna","40138",{"lat":495,"lon":496},44.49381,11.33875,{"facility":498,"status":8,"city":499,"state":492,"zip":500,"country":474,"geoPoint":501},"Istituto Romagnolo per lo Studio dei Tumori \"Dino Amadori\" - IRST S.r.l","Meldola","47014",{"lat":502,"lon":503},44.12775,12.0626,{"facility":505,"status":8,"city":506,"state":492,"zip":507,"country":474,"geoPoint":508},"Azienda USL IRCCS di Reggio Emilia","Reggio Emilia","42123",{"lat":509,"lon":510},44.69825,10.63125,{"facility":512,"status":8,"city":513,"state":514,"zip":515,"country":474,"geoPoint":516},"Azienda Sanitaria Universitaria Friuli Centrale","Udine","Friuli Venezia Giulia","33100",{"lat":517,"lon":518},46.0693,13.23715,{"facility":520,"status":8,"city":521,"state":522,"zip":523,"country":474,"geoPoint":524},"Fondazione Policlinico Universitario Campus Bio-Medico di Roma","Rome","Lazio","00128",{"lat":525,"lon":526},41.89193,12.51133,{"facility":528,"status":8,"city":529,"state":530,"zip":531,"country":474,"contacts":532,"geoPoint":535},"Azienda Ospedaliera Papa Giovanni XXIII","Bergamo","Lombardy","24127",[533],{"name":534,"role":132},"Federico Lussana",{"lat":536,"lon":537},45.69601,9.66721,{"facility":539,"status":8,"city":540,"state":530,"zip":541,"country":474,"geoPoint":542},"Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico","Milan","20122",{"lat":543,"lon":544},45.46427,9.18951,{"facility":546,"status":8,"city":547,"state":548,"zip":549,"country":474,"geoPoint":550},"Azienda Sanitaria Ospedaliera S. Croce e Carle","Cuneo","Piedmont","12100",{"lat":551,"lon":552},44.39071,7.54828,{"facility":554,"status":8,"city":555,"state":548,"zip":556,"country":474,"geoPoint":557},"A.O.U. Maggiore della Carità","Novara","28100",{"lat":558,"lon":559},45.44694,8.62118,{"facility":561,"status":8,"city":562,"state":548,"zip":563,"country":474,"geoPoint":564},"Azienda Ospedaliera Città della Salute e della Scienza di Torino","Turin","10126",{"lat":565,"lon":566},45.07049,7.68682,{"facility":568,"status":100,"city":569,"state":570,"zip":571,"country":474,"geoPoint":572},"Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco di Catania","Catania","Sicily","95123",{"lat":573,"lon":574},37.49223,15.07041,{"facility":576,"status":8,"city":577,"state":570,"zip":578,"country":474,"geoPoint":579},"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone","Palermo","90127",{"lat":580,"lon":581},38.1166,13.3636,{"facility":583,"status":8,"city":584,"state":585,"zip":586,"country":474,"geoPoint":587},"Azienda Ospedaliero Universitaria delle Marche","Ancona","The Marches","60126",{"lat":588,"lon":589},43.60717,13.5103,{"facility":591,"status":8,"city":592,"state":593,"zip":594,"country":474,"geoPoint":595},"Azienda Ospedaliera Universitaria Careggi","Florence","Tuscany","50134",{"lat":596,"lon":597},43.77925,11.24626,{"facility":599,"status":100,"city":600,"state":601,"zip":602,"country":603,"geoPoint":604},"Spaarne Gasthuis","Hoofddorp","North Holland","2134 TM","Netherlands",{"lat":605,"lon":606},52.3025,4.68889,{"facility":608,"status":100,"city":609,"state":610,"zip":611,"country":603,"geoPoint":612},"Medisch Spectrum Twente","Enschede","Overijssel","7512 KZ",{"lat":613,"lon":614},52.21833,6.89583,{"facility":616,"status":100,"city":617,"state":618,"zip":619,"country":603,"geoPoint":620},"Albert Schweitzer Ziekenhuis","Dordrecht","South Holland","3318 AT",{"lat":621,"lon":622},51.81,4.67361,{"facility":624,"status":8,"city":625,"zip":626,"country":627,"geoPoint":628},"Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Woźny","Poznan","60-549","Poland",{"lat":629,"lon":630},52.40692,16.92993,{"facility":632,"status":8,"city":633,"zip":634,"country":627,"geoPoint":635},"Specjalistyczny Szpital im. dra Alfreda Sokołowskiego","Wałbrzych","58-309",{"lat":636,"lon":637},50.77141,16.28432,{"facility":639,"status":100,"city":640,"zip":641,"country":627,"geoPoint":642},"Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckiego we Wrocławiu","Wroclaw","50-367",{"lat":643,"lon":644},51.10286,17.03006,{"facility":646,"status":8,"city":647,"zip":648,"country":649,"geoPoint":650},"Clinical Hospital Center Bezanijska Kosa","Belgrade","11000","Serbia",{"lat":651,"lon":652},44.80401,20.46513,{"facility":654,"status":8,"city":647,"zip":648,"country":649,"geoPoint":655},"Clinical Hospital Center Zemun",{"lat":651,"lon":652},{"facility":657,"status":385,"city":647,"zip":648,"country":649,"geoPoint":658},"University Clinical Center of Serbia",{"lat":651,"lon":652},{"facility":660,"status":8,"city":661,"zip":662,"country":649,"geoPoint":663},"University Clinical Center Nis","Niš","18000",{"lat":664,"lon":665},43.32472,21.90333,{"facility":667,"status":8,"city":668,"zip":669,"country":649,"geoPoint":670},"Clinical Center of Vojvodina","Novi Sad","21000",{"lat":671,"lon":672},45.25167,19.83694,{"facility":674,"status":100,"city":675,"state":676,"zip":677,"country":678,"geoPoint":679},"ICO Badalona-H.U. Germans Trias i Pujol","Badalona","Barcelona","8916","Spain",{"lat":680,"lon":681},41.45004,2.24741,{"facility":683,"status":385,"city":684,"zip":685,"country":678,"geoPoint":686},"Hospital General Universitario Dr. Balmis","Alicante","3010",{"lat":687,"lon":688},38.34517,-0.48149,{"facility":690,"status":8,"city":691,"zip":692,"country":678,"geoPoint":693},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"lat":694,"lon":695},40.4165,-3.70256,{"facility":697,"status":8,"city":698,"zip":699,"country":678,"geoPoint":700},"Hospital Universitario Virgen de la Victoria","Málaga","29010",{"lat":701,"lon":702},36.72016,-4.42034,{"facility":704,"status":8,"city":705,"zip":706,"country":678,"geoPoint":707},"Hospital Universitari i Politecnic La Fe de Valencia","Valencia","46026",{"lat":708,"lon":709},39.47391,-0.37966,{"facility":711,"status":712,"city":713,"state":714,"country":715,"geoPoint":716},"Medical Park Bahcelievler Hastanesi","ENROLLING_BY_INVITATION","Bahçelievler","Istanbul","Turkey (Türkiye)",{"lat":717,"lon":718},41.00231,28.8598,{"facility":720,"status":8,"city":721,"state":722,"country":715,"contacts":723,"geoPoint":726},"Ege Universitesi Tip Fakultesi","Bornova","İzmir",[724],{"name":725,"role":186},"Mahmut Tobu",{"lat":727,"lon":728},38.47921,27.2399,{"facility":730,"status":8,"city":731,"state":732,"country":715,"contacts":733,"geoPoint":737},"VM Medical Park Mersin Hospital - Ataturk","Mezitli","Mersin",[734,736],{"name":735,"role":132},"Anil Tombak",{"name":735,"role":186},{"lat":738,"lon":739},36.74541,34.52256,{"facility":741,"status":8,"city":742,"state":743,"country":715,"contacts":744,"geoPoint":748},"Namik Kemal Universitesi Saglik Uygulama ve Arastirma Merkezi","Altınova","Terkirdag",[745,747],{"name":746,"role":132},"Seval Akapinar",{"name":746,"role":186},{"lat":749,"lon":750},40.69495,29.50986,{"facility":752,"status":385,"city":753,"zip":754,"country":755,"geoPoint":756},"Belfast City Hospital","Belfast","BT9 7AB","United Kingdom",{"lat":757,"lon":758},54.59682,-5.92541,{"facility":760,"status":8,"city":761,"country":755,"contacts":762,"geoPoint":766},"Pilgrim Hospital","Boston",[763,765],{"name":764,"role":132},"Ciro Rinaldi",{"name":764,"role":186},{"lat":767,"lon":768},52.97633,-0.02664,{"facility":770,"status":8,"city":771,"zip":772,"country":755,"geoPoint":773},"Imperial College Healthcare NHS Trust","London","W12 0HS",{"lat":774,"lon":775},51.50853,-0.12574,{"facility":777,"status":8,"city":778,"country":755,"contacts":779,"geoPoint":783},"Milton Keynes University Hospital","Milton Keynes",[780,782],{"name":781,"role":132},"Magbor Akanni",{"name":781,"role":186},{"lat":784,"lon":785},52.04172,-0.75583,{"facility":787,"status":8,"city":788,"country":755,"geoPoint":789},"University of Oxford - The Weatherall Institute of Molecular Medicine (WIMM)","Oxford",{"lat":790,"lon":791},51.75222,-1.25596,{"facility":793,"status":8,"city":794,"country":755,"contacts":795,"geoPoint":798},"Southampton General Hospital","Southampton",[796],{"name":797,"role":186},"Srinivasan Narayanan",{"lat":799,"lon":800},50.90395,-1.40428,[802],{"name":803,"role":132,"phone":804,"email":805},"Maurizio Caserini","+39 02 6443 1","patientadvocacy@italfarmacogroup.com",[],[],[],{"nct_id":4,"conditions":810,"biomarkers":811},[19],[],{"nct_id":4,"found":15,"summary":813,"prompt_version":823},{"design":814,"status":815,"heading":816,"summary":817,"follow_up":818,"word_count":819,"commitments":820,"compensation":821,"drugs_mentioned":822},"This is an interventional study comparing givinostat to hydroxyurea, with a planned enrollment of 220 participants.","completed","Givinostat vs. Hydroxyurea for Polycythemia Vera","This study is comparing two oral medications, givinostat and hydroxyurea, for people with Polycythemia Vera (PV). PV is a blood disorder where your body makes too many red blood cells, often due to a specific gene change called JAK2V617F. The goal is to see if givinostat is more effective and safer than hydroxyurea in controlling PV, especially for patients at high risk for blood clots. To join, you must have been diagnosed with PV according to specific criteria and have the JAK2V617F gene change. You also need to be considered high-risk for blood clots, meaning you are 60 years or older, or have had a blood clot before. The study will measure how many patients respond to treatment after 48 weeks. The current recruitment status is unclear.","The primary endpoint is measured at week 48, and there is an extended treatment phase to collect long-term data.",127,"Not specified in the trial record.","Not stated in the trial record.",[21,38],"v2"]