Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

PHASE3RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

March 26, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Polycythemia Vera
Interventions
DRUG

Givinostat

Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

DRUG

Hydroxyurea

Oral. The dosage must be modified, according to the manifestation of toxicities or lack of efficacy, with the aim to achieve an optimized dose.

Trial Locations (76)

7

RECRUITING

Mater Misericordiae University Hospital, Dublin

15

NOT_YET_RECRUITING

Connolly Hospital Blanchardstown, Dublin

1090

RECRUITING

Medizinische Universitat Wien (Medical University of Vienna), Vienna

1407

RECRUITING

Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, Sofia

2100

RECRUITING

Centre Hospitalier de Saint-Quentin, Saint-Quentin

2700

RECRUITING

Landesklinikum Wiener Neustadt, Wiener Neustadt

3010

RECRUITING

Hospital General Universitario Dr. Balmis, Alicante

4001

RECRUITING

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv

4020

RECRUITING

Ordensklinikum Linz GmbH Elisabethinen, Linz

4400

RECRUITING

Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyháza

4600

RECRUITING

Klinikum Wels-Grieskirchen GmbH, Wels

6003

RECRUITING

University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD, Stara Zagora

6202

RECRUITING

CHU de Nice, Nice

7100

RECRUITING

Tolna Vármegyei Megyei Balassa János Kórház, Szekszárd

8916

NOT_YET_RECRUITING

ICO Badalona-H.U. Germans Trias i Pujol, Badalona

9024

RECRUITING

Gyor-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház, Győr

10000

RECRUITING

Clinical Hospital Dubrava, Zagreb

RECRUITING

Centre Hospitalier de Troyes, Troyes

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10126

RECRUITING

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin

11000

RECRUITING

Clinical Hospital Center Bezanijska Kosa, Belgrade

RECRUITING

Clinical Hospital Center Zemun, Belgrade

RECRUITING

University Clinical Center of Serbia, Belgrade

12100

RECRUITING

Azienda Sanitaria Ospedaliera S. Croce e Carle, Cuneo

18000

RECRUITING

University Clinical Center Nis, Niš

20122

RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

20852

RECRUITING

American Oncology Partners of Maryland, PA, Bethesda

21000

RECRUITING

Clinical Center of Vojvodina, Novi Sad

22000

NOT_YET_RECRUITING

General Hospital Sibenik, Šibenik

22081

RECRUITING

OncoResearch Lerchenfeld GmbH, Hamburg

24127

RECRUITING

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

28034

RECRUITING

Hospital Universitario Ramon y Cajal, Madrid

28100

RECRUITING

A.O.U. Maggiore della Carità, Novara

29010

RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

31048

TERMINATED

Bnai Zion Medical Center, Haifa

33100

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale, Udine

34362

TERMINATED

Carmel Medical Center, Haifa

37044

RECRUITING

Hôpital Bretonneau, Tours

40138

RECRUITING

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico, Bologna

42123

RECRUITING

Azienda USL IRCCS di Reggio Emilia, Reggio Emilia

44000

RECRUITING

CHU Nantes, Nantes

44195

RECRUITING

The Cleveland Clinic Foundation, Cleveland

46026

RECRUITING

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

47014

RECRUITING

"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l", Meldola

49000

RECRUITING

CHU Angers, Angers

50134

RECRUITING

Azienda Ospedaliera Universitaria Careggi, Florence

51000

RECRUITING

Clinical Hospital Center Rijeka - PPDS, Rijeka

NOT_YET_RECRUITING

Clinical Hospital Center Rijeka, Rijeka

60000

RECRUITING

Assuta Medical Center, Tel Aviv

60126

RECRUITING

Azienda Ospedaliero Universitaria delle Marche, Ancona

68167

RECRUITING

Medizinische Fakultät Mannheim der Universität Heidelberg, Universitätsmedizin Mannheim, Mannheim

70124

RECRUITING

"Istituto Tumori Giovanni Paolo II I.R.C.C.S.", Bari

75010

RECRUITING

Hôpital Saint Louis, Paris

77030

RECRUITING

MD Anderson Cancer Center, Houston

80054

RECRUITING

CHU Amiens Hôpital Sud, Amiens

84112

RECRUITING

University of Utah - Huntsman Cancer Institute - PPDS, Salt Lake City

89133

RECRUITING

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria

90127

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

91120

TERMINATED

Hadassah Medical Center - PPDS, Jerusalem

92373

RECRUITING

Emad Ibrahim, MD, Inc, Redlands

95107

NOT_YET_RECRUITING

Hopital d'Argenteuil, Argenteuil

95123

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco di Catania, Catania

35294-0001

NOT_YET_RECRUITING

University of Alabama at Birmingham, Birmingham

98108-1532

RECRUITING

VA Puget Sound Health Care System - NAVREF - PPDS, Seattle

01307

RECRUITING

Gemeinschaftspraxis Hämatologie - Onkologie, Dresden

06120

RECRUITING

Universitätsmedizin Halle, Universitätsklinikum Halle, Klinik für Innere Medizin IV, Halle

Unknown

RECRUITING

Cork University Hospital, Cork

00128

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico di Roma, Rome

2134 TM

NOT_YET_RECRUITING

Spaarne Gasthuis, Hoofddorp

7512 KZ

NOT_YET_RECRUITING

Medisch Spectrum Twente, Enschede

3318 AT

NOT_YET_RECRUITING

Albert Schweitzer Ziekenhuis, Dordrecht

60-549

RECRUITING

Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Woźny, Poznan

58-309

RECRUITING

Specjalistyczny Szpital im. dra Alfreda Sokołowskiego, Wałbrzych

50-367

NOT_YET_RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckiego we Wrocławiu, Wroclaw

BT9 7AB

NOT_YET_RECRUITING

Belfast City Hospital, Belfast

W12 0HS

RECRUITING

Imperial College Healthcare NHS Trust, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Italfarmaco

INDUSTRY