Phase 3 study to assess the efficacy and safety of Givinostat versus hydroxyurea in Polycythemia Vera patients

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• 1. Patients pre-treated with HU with a documented history of resistance or intolerance to HU. 2. Patients with clinically significant bacterial, fungal, parasitic or viral infection that requires treatment 3. Patients with a positive test for hepatitis B virus surface antigen, hepatitis C virus antibodies (anti-HCV) or human immunodeficiency virus (HIV) antibodies at screening. 4. Patients diagnosed with primary immunodeficiency syndromes, e.g., X-linked agammaglobulinemia and common variable immune deficiency. 5. 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. 6. Patients with clinically significant cardiovascular disease, including uncontrolled hypertension, New York Heart Association Grade III or greater congestive heart failure, torsades de pointes (TdP) and hypokalemia at screening. 7. Patients with myocardial infarction, stroke or unstable angina within the 6 months prior to screening. 8. Splanchnic thrombosis and/or thrombosis of the cerebral venous sinuses and/or splenectomy in the medical history. 9. Patients with inadequate liver or renal function at screening.
• 7. Patients with a QTcF value at Week 48 of > 450 msec for males and > 460 msec for females confirmed by central reading; congenital or acquired history of QTc prolongation or ventricular arrhythmias, at Week 48.
• 8. Being either resistant or intolerant to HU. Please refer to Protocol, section 5.3 for detailed list of exclusion criteria
• 10. PLT count ≤ 150 × 109/L at screening (test may be repeated once). 11. ANC < 1.2 × 109/L at screening (test may be repeated once). 12. Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 × ULN (test may be repeated once). 13. Presence of other clinically significant disease that, in the Investigator’s opinion, could adversely affect the safety of the patient, making it unlikely that the course of treatment or FU is completed, or could impair the assessment of study results 14. History of major organ transplantation. 15. Patients with documented GI disease that may significantly alter the absorption of oral drugs. 16. Patients with an active malignancy over the 5 years prior to screening, except intraepithelial neoplasia, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix or early-stage prostate cancer, treated and considered cured
• 17. Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy 18. Patients receiving treatment with interferon or pipobroman within the 5 weeks prior to screening 19. Patients receiving anagrelide within 7 days prior to screening. 20. Patients receiving busulfan or chlorambucil within 2 weeks prior to screening 21. Patients being treated concurrently with any investigational agent or prior participation in an interventional clinical trial within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer 22. Patients with known hypersensitivity to components of the study drugs 23. Pregnant or nursing (lactating) women Please refer to Protocol, section 5.3 for detailed list of exclusion criteria
• Extended treatment phase: 1. Patients with known hypersensitivity to components of the study drug.