Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-59
SponsorPharmaEssentia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Hematocrit <45%, and
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Ropeginterferon alfa-2b
DrugRopeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), 250 µg at Day 1, 350 µg at Week 2, and target optimal dose of 500 µg at Week 4. Phlebotomy should be conducted if confirmed Hct ≥48%, or confirmed Hct ≥45% that is ≥3% higher than baseline Hct value.
Phlebotomy and aspirin
Procedure/SurgeryPhlebotomy should be conducted if confirmed Hct ≥48%, or confirmed Hct ≥45% that is ≥3% higher than baseline Hct value, or confirmed Hct ≥45% according to the standard of care for phlebotomy at the institution regardless of the magnitude of the increase compared with the baseline. The same standard or criteria for phlebotomy eligibility should be applied for patients during the study at each study site or institution.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Ropeginterferon alfa-2b groupExperimental treatment 2 interventions
Group B: Control groupOther 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients whose Hct is maintained without phlebotomy eligibility from Week 20 through Week 32.
Phlebotomy eligibility is defined as either: a confirmed Hct ≥45% that is at least 3% higher than the baseline Hct, a confirmed Hct ≥48%, OR a confirmed Hct ≥45% according to the standard of care for phlebotomy at the institution regardless of the magnitude of the increase compared with the baseline.
Time frame
From Week 20 through Week 32Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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