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Jana Mikulicza- Radeckiego we Wrocławiu","Wroclaw","50-367",{"type":49,"coordinates":736},[737,738],17.03006,51.10286,{"lat":738,"lon":737},{"facility":741,"status":56,"city":742,"state":32,"zip":743,"country":744,"countryCode":745,"cosmosGeoPoint":746,"geoPoint":750,"contacts":32},"Clinical Hospital Center Bezanijska Kosa","Belgrade","11000","Serbia","RS",{"type":49,"coordinates":747},[748,749],20.46513,44.80401,{"lat":749,"lon":748},{"facility":752,"status":56,"city":742,"state":32,"zip":743,"country":744,"countryCode":745,"cosmosGeoPoint":753,"geoPoint":755,"contacts":32},"Clinical Hospital Center Zemun",{"type":49,"coordinates":754},[748,749],{"lat":749,"lon":748},{"facility":757,"status":406,"city":742,"state":32,"zip":743,"country":744,"countryCode":745,"cosmosGeoPoint":758,"geoPoint":760,"contacts":32},"University Clinical Center of Serbia",{"type":49,"coordinates":759},[748,749],{"lat":749,"lon":748},{"facility":762,"status":56,"city":763,"state":32,"zip":764,"country":744,"countryCode":745,"cosmosGeoPoint":765,"geoPoint":769,"contacts":32},"University Clinical Center Nis","Niš","18000",{"type":49,"coordinates":766},[767,768],21.90333,43.32472,{"lat":768,"lon":767},{"facility":771,"status":56,"city":772,"state":32,"zip":773,"country":744,"countryCode":745,"cosmosGeoPoint":774,"geoPoint":778,"contacts":32},"Clinical Center of Vojvodina","Novi Sad","21000",{"type":49,"coordinates":775},[776,777],19.83694,45.25167,{"lat":777,"lon":776},{"facility":780,"status":42,"city":781,"state":782,"zip":783,"country":784,"countryCode":785,"cosmosGeoPoint":786,"geoPoint":790,"contacts":32},"ICO Badalona-H.U. 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The Weatherall Institute of Molecular Medicine (WIMM)","Oxford",{"type":49,"coordinates":924},[925,926],-1.25596,51.75222,{"lat":926,"lon":925},{"facility":929,"status":56,"city":930,"state":32,"zip":32,"country":880,"countryCode":881,"cosmosGeoPoint":931,"geoPoint":935,"contacts":936},"Southampton General Hospital","Southampton",{"type":49,"coordinates":932},[933,934],-1.40428,50.90395,{"lat":934,"lon":933},[937],{"name":938,"role":155,"phone":32,"phoneExt":32,"email":32},"Srinivasan Narayanan",{"type":940,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[942],{"name":943,"class":6},"PPD Development, LP","100523284","phase-3-study-on-efficacy-and-safety-of-givinostat-versus-hydroxyurea-in-patients-with-polycythemia-vera-100523284",false,"NCT06093672","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","GIV-IN-PV","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","ALL","18 Years",{"count":955,"type":956},220,"ESTIMATED","INTERVENTIONAL",[959],"PHASE3","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.",[962],"Polycythemia Vera",[962,23],"2026-03-24",{"date":966,"type":967},"2026-03-25","ACTUAL",{"date":969,"type":967},"2024-03-26",{"date":971,"type":956},"2026-07",{"name":5,"class":6},90]