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

Inclusion Criteria:

Patients must have been diagnosed with PV according to the 2016 WHO criteria within 3 years before randomization
Patients must have JAK2V617F-positive disease

Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at screening as follows:

Age > 60 years, and/or
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 < 45% with at least 1 phlebotomy performed in the 3 months before screening, or
WBC count > 10 × 109/L, or
PLT count > 400 × 109/L.
Patients must have normalized HCT (i.e., HCT < 45%) at randomization

Exclusion Criteria:

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
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