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

Sponsor
PharmaEssentia
Study ID
NCT06290765
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Myeloproliferative Neoplasm
  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • Ropeginterferon alfa-2b — DRUG
    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.
  • Phlebotomy and aspirin — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ropeginterferon alfa-2b group
    Ropeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), target optimal dose of 500 µg.
  • Other: Control group
    Patients will continuously receive the same therapy as s/he received for PV indication prior to screening.

Primary Outcome Measure

The proportion of patients whose Hct is maintained without phlebotomy eligibility from Week 20 through Week 32. [ Time Frame: From Week 20 through Week 32 ]

Central Contacts

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