Clinical Trial Finder

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

Arms

Experimental: Givinostat

Active Comparator: Hydroxyurea

Interventions

Drug: - Givinostat Hydrochloride

Oral. Starting dose of 50 mg BID with individualized dose titration ranging from 50 mg OD to 100 mg BID based on safety and efficacy

Drug: - Hydroxy Urea

Oral. Starting dose of 500 mg BID with individualized dose titration ranging from 500 mg OD to 1500 mg BID based on safety and efficacy