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
Qualifiers
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
Treatments tested in this trial
- Ropeginterferon alfa-2b
- Phlebotomy and aspirin
Treatment groups
70 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov