Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera
Key claim: A randomized open-label multicenter trial will evaluate the efficacy and safety of ropeginterferon alfa-2b (P1101) over 60 weeks in approximately 70 patients with polycythemia vera.
Abstract
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.
Why this matters
A randomized open-label multicenter trial will evaluate the efficacy and safety of ropeginterferon alfa-2b (P1101) over 60 weeks in approximately 70 patients with polycythemia vera.