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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

February 1, 2026

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Polycythemia VeraMyeloproliferative Neoplasm
Interventions
DRUG

Ropeginterferon alfa-2b

"Ropeginterferon 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."

PROCEDURE

Phlebotomy and aspirin

Phlebotomy 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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaEssentia

INDUSTRY