Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
ConditionPolycythemia Vera
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorItalfarmaco
About this trial
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.
Eligibility criteria
Qualifiers
Patients must have been diagnosed with PV according to the 2016 WHO criteria before randomization
Patients must have JAK2V617F-positive disease
Age ≥ 60 years, and/or
Prior thrombosis.
Disqualifiers
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/or thrombosis of the cerebral venous sinuses and/or splenectomy in the medical history
Patients with clinically significant cardiovascular disease
Trial design
Treatments tested in this trial
- Givinostat
- Hydroxyurea
Treatment groups
220 Participants
are divided into 2 treatment groupsLocations
90Austria
Landesklinikum Wiener Neustadt2700, Wiener NeustadtLower Austria, Austria
Medizinische Universitat Wien (Medical University of Vienna)1090, ViennaState of Vienna, Austria
Ordensklinikum Linz GmbH Elisabethinen4020, LinzUpper Austria, Austria
Klinikum Wels-Grieskirchen GmbH4600, WelsUpper Austria, Austria
Sponsors and collaborators
Italfarmaco
Lead sponsor
PPD Development, LP
Collaborator
Source ClinicalTrials.gov