Clinical Trial

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera

Study acronym: PV

Withdrawn Phase 4

View on ClinicalTrials.gov →

Why the trial stopped

In alignment with company strategic direction.

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.

Protocol Amendment History 3 changes

critical Withdrawn before enrolling 2026-08-01

critical Trial withdrawn: In alignment with company strategic direction. 2026-08-01

critical Enrollment reduced: 70 -> 0 participants 2026-08-01

Trial Details

NCT Number	NCT06290765
Lead Sponsor	PharmaEssentia
Conditions	Polycythemia Vera, Myeloproliferative Neoplasm
Start Date	2026-08-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-31