Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera
This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks).
- EligibilityCriteria: Inclusion Criteria:  Patients ≥18 and ˂60 years old; PV according WHO 2022 Criteria; Low-risk PV according to the NCCN guideline; Hct value lower than 45%; JAK2 V617F or exon 12 mutation AND a bone marrow biopsy performed with morphology consistent with PV and reticulin fibrosis grade of 0-1; Females of childbearing potential must agree to use an acceptable form of birth control; Written informed consent obtained from the patient or the patient's legal representative  Exclusion Criteria:  Previous well documented cardiovascular PV-related events; Prior use of cytoreductive agents in the past 4 weeks prior to randomization; Any contraindication to pegylated interferon or its excipients; Non-responder or resistance to interferon or any other cytoreductive therapies; Documented autoimmune disease at screening or in the medical history; Prior or current autoimmune thyroid disease; Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol; Infections with systemic manifestations except hepatitis B (HBV) and/or hepatitis C (HCV), at screening; Any investigational drug less than 6 weeks prior to the first dose of study drug; History or presence of depression requiring treatment with antidepressant; Previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator; Any significant morbidity or abnormality which may interfere with the study participation; Pregnant or lactating females; History of alcohol abuse or drug abuse within the last year; Evidence of severe retinopathy; Significant liver or renal disease; History of major organ transplantation; History or presence of clinically significant neurologic diseases; History of malignant disease, including solid tumours and hematological malignancies within the last 3 years. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult