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Jana Mikulicza- Radeckiego we Wrocławiu","Wroclaw","50-367",{"type":48,"coordinates":724},[725,726],17.03006,51.10286,{"lat":726,"lon":725},{"facility":729,"status":55,"city":730,"state":32,"zip":731,"country":732,"cosmosGeoPoint":733,"geoPoint":737,"contacts":32},"Clinical Hospital Center Bezanijska Kosa","Belgrade","11000","Serbia",{"type":48,"coordinates":734},[735,736],20.46513,44.80401,{"lat":736,"lon":735},{"facility":739,"status":55,"city":730,"state":32,"zip":731,"country":732,"cosmosGeoPoint":740,"geoPoint":742,"contacts":32},"Clinical Hospital Center Zemun",{"type":48,"coordinates":741},[735,736],{"lat":736,"lon":735},{"facility":744,"status":400,"city":730,"state":32,"zip":731,"country":732,"cosmosGeoPoint":745,"geoPoint":747,"contacts":32},"University Clinical Center of Serbia",{"type":48,"coordinates":746},[735,736],{"lat":736,"lon":735},{"facility":749,"status":55,"city":750,"state":32,"zip":751,"country":732,"cosmosGeoPoint":752,"geoPoint":756,"contacts":32},"University Clinical Center Nis","Niš","18000",{"type":48,"coordinates":753},[754,755],21.90333,43.32472,{"lat":755,"lon":754},{"facility":758,"status":55,"city":759,"state":32,"zip":760,"country":732,"cosmosGeoPoint":761,"geoPoint":765,"contacts":32},"Clinical Center of Vojvodina","Novi Sad","21000",{"type":48,"coordinates":762},[763,764],19.83694,45.25167,{"lat":764,"lon":763},{"facility":767,"status":42,"city":768,"state":769,"zip":770,"country":771,"cosmosGeoPoint":772,"geoPoint":776,"contacts":32},"ICO Badalona-H.U. Germans Trias i Pujol","Badalona","Barcelona","8916","Spain",{"type":48,"coordinates":773},[774,775],2.24741,41.45004,{"lat":775,"lon":774},{"facility":778,"status":400,"city":779,"state":32,"zip":780,"country":771,"cosmosGeoPoint":781,"geoPoint":785,"contacts":32},"Hospital General Universitario Dr. Balmis","Alicante","3010",{"type":48,"coordinates":782},[783,784],-0.48149,38.34517,{"lat":784,"lon":783},{"facility":787,"status":55,"city":788,"state":32,"zip":789,"country":771,"cosmosGeoPoint":790,"geoPoint":794,"contacts":32},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":48,"coordinates":791},[792,793],-3.70256,40.4165,{"lat":793,"lon":792},{"facility":796,"status":55,"city":797,"state":32,"zip":798,"country":771,"cosmosGeoPoint":799,"geoPoint":803,"contacts":32},"Hospital Universitario Virgen de la Victoria","Málaga","29010",{"type":48,"coordinates":800},[801,802],-4.42034,36.72016,{"lat":802,"lon":801},{"facility":805,"status":55,"city":806,"state":32,"zip":807,"country":771,"cosmosGeoPoint":808,"geoPoint":812,"contacts":32},"Hospital Universitari i Politecnic La Fe de Valencia","Valencia","46026",{"type":48,"coordinates":809},[810,811],-0.37966,39.47391,{"lat":811,"lon":810},{"facility":814,"status":815,"city":816,"state":817,"zip":32,"country":818,"cosmosGeoPoint":819,"geoPoint":823,"contacts":32},"Medical Park Bahcelievler Hastanesi","ENROLLING_BY_INVITATION","Bahçelievler","Istanbul","Turkey (Türkiye)",{"type":48,"coordinates":820},[821,822],28.8598,41.00231,{"lat":822,"lon":821},{"facility":825,"status":55,"city":826,"state":827,"zip":32,"country":818,"cosmosGeoPoint":828,"geoPoint":832,"contacts":833},"Ege Universitesi Tip Fakultesi","Bornova","İzmir",{"type":48,"coordinates":829},[830,831],27.2399,38.47921,{"lat":831,"lon":830},[834],{"name":835,"role":154,"phone":32,"phoneExt":32,"email":32},"Mahmut Tobu",{"facility":837,"status":55,"city":838,"state":839,"zip":32,"country":818,"cosmosGeoPoint":840,"geoPoint":844,"contacts":845},"VM Medical Park Mersin Hospital - Ataturk","Mezitli","Mersin",{"type":48,"coordinates":841},[842,843],34.52256,36.74541,{"lat":843,"lon":842},[846,848],{"name":847,"role":36,"phone":32,"phoneExt":32,"email":32},"Anil Tombak",{"name":847,"role":154,"phone":32,"phoneExt":32,"email":32},{"facility":850,"status":55,"city":851,"state":852,"zip":32,"country":818,"cosmosGeoPoint":853,"geoPoint":857,"contacts":858},"Namik Kemal Universitesi Saglik Uygulama ve Arastirma Merkezi","Altınova","Terkirdag",{"type":48,"coordinates":854},[855,856],29.50986,40.69495,{"lat":856,"lon":855},[859,861],{"name":860,"role":36,"phone":32,"phoneExt":32,"email":32},"Seval Akapinar",{"name":860,"role":154,"phone":32,"phoneExt":32,"email":32},{"facility":863,"status":400,"city":864,"state":32,"zip":865,"country":866,"cosmosGeoPoint":867,"geoPoint":871,"contacts":32},"Belfast City Hospital","Belfast","BT9 7AB","United Kingdom",{"type":48,"coordinates":868},[869,870],-5.92541,54.59682,{"lat":870,"lon":869},{"facility":873,"status":55,"city":874,"state":32,"zip":32,"country":866,"cosmosGeoPoint":875,"geoPoint":879,"contacts":880},"Pilgrim Hospital","Boston",{"type":48,"coordinates":876},[877,878],-0.02664,52.97633,{"lat":878,"lon":877},[881,883],{"name":882,"role":36,"phone":32,"phoneExt":32,"email":32},"Ciro Rinaldi",{"name":882,"role":154,"phone":32,"phoneExt":32,"email":32},{"facility":885,"status":55,"city":886,"state":32,"zip":887,"country":866,"cosmosGeoPoint":888,"geoPoint":892,"contacts":32},"Imperial College Healthcare NHS Trust","London","W12 0HS",{"type":48,"coordinates":889},[890,891],-0.12574,51.50853,{"lat":891,"lon":890},{"facility":894,"status":55,"city":895,"state":32,"zip":32,"country":866,"cosmosGeoPoint":896,"geoPoint":900,"contacts":901},"Milton Keynes University Hospital","Milton Keynes",{"type":48,"coordinates":897},[898,899],-0.75583,52.04172,{"lat":899,"lon":898},[902,904],{"name":903,"role":36,"phone":32,"phoneExt":32,"email":32},"Magbor Akanni",{"name":903,"role":154,"phone":32,"phoneExt":32,"email":32},{"facility":906,"status":55,"city":907,"state":32,"zip":32,"country":866,"cosmosGeoPoint":908,"geoPoint":912,"contacts":32},"University of Oxford - The Weatherall Institute of Molecular Medicine (WIMM)","Oxford",{"type":48,"coordinates":909},[910,911],-1.25596,51.75222,{"lat":911,"lon":910},{"facility":914,"status":55,"city":915,"state":32,"zip":32,"country":866,"cosmosGeoPoint":916,"geoPoint":920,"contacts":921},"Southampton General Hospital","Southampton",{"type":48,"coordinates":917},[918,919],-1.40428,50.90395,{"lat":919,"lon":918},[922],{"name":923,"role":154,"phone":32,"phoneExt":32,"email":32},"Srinivasan Narayanan",{"type":925,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[927],{"name":928,"class":6},"PPD Development, LP","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":939,"type":940},220,"ESTIMATED","INTERVENTIONAL",[943],"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.",[946],"Polycythemia Vera",[946,23],"2026-03-24",{"date":950,"type":951},"2026-03-25","ACTUAL",{"date":953,"type":951},"2024-03-26",{"date":955,"type":940},"2026-07",{"name":5,"class":6},90]