Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera (NCT06290765) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera
70 participantsStarted 2026-02-01
Plain-language summary
This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years at the time of informed consent (or other age required by local regulations);
✓. PV according to the World Health Organization (WHO) 2016 or 2022 Criteria;
✓. At least 3 phlebotomies within 24 weeks or at least 5 phlebotomies within 52 weeks prior to screening due to inadequate control of Hct value;
✓. Have the following hematological values immediately prior to randomization at baseline:
✓. Hematocrit \<45%, and
✓. WBC ≥4× 109/L, and
✓. Platelets ≥100 × 109/L;
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Exclusion criteria
✕. Patients requiring phlebotomy at Hct levels ˂45% according to Investigator judgement;
✕. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) or PV-related bleeding within 2 months prior to randomization;
✕. Post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) (Tefferi et al 2013, Barosi et al 2008);
✕. Contraindication to pegylated interferon or its excipients;
✕
What they're measuring
1
The proportion of patients whose Hct is maintained without phlebotomy eligibility from Week 20 through Week 32.
. known resistance or intolerance to interferon based therapies, as judged by Investigator;
✕. Documented autoimmune disease (e.g., thyroid dysfunction, idiopathic thrombocytopenic purpura (ITP), scleroderma, psoriasis, or any arthritis of autoimmune origin). Patients with well-managed thyroid disease by oral hormonal replacement therapy could be enrolled;
✕. Pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety or compliance with the protocol;
✕. Infections with systemic manifestations, e.g., bacterial, fungal, or human immunodeficiency virus (HIV), except inactive carriers of hepatitis B (HBV) and/or hepatitis C (HCV) at screening; inactive HBV carrier is defined as the presence of HBsAg and anti-Hepatitis B e-antigen (anti-HBe) antibody, HBV DNA ˂2000 IU/ml, and normal ALT (Invernizz et al 2016); inactive HCV carrier is defined as the presence of HCV RNA but has normal ALT or with no clinically significant symptom as judged by investigator;