A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Sponsor
PharmaEssentia
Study ID
NCT05485948
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ropeginterferon alfa-2b — DRUG
    Initial dose of 250 µg at Week 0, a medium dose of 350 µg at Week 2, a target dose of 500 µg at Week 4, and a maintenance dose of 500 µg until Week 52.

Study Details

This study is a phase II single-arm study designed to evaluate the efficacy and safety of P1101 in Chinese PV patients who are intolerance or resistance to HU.

Key Dates

Start date
Oct 8, 2021
Status verified
Jul 2025
Primary completion
Sep 7, 2022
Completion
Jul 31, 2027

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with P1101
    Subjects who meet all the inclusion criteria and do not meet any of the exclusion criteria will start treatment with P1101. The study drug will be subcutaneously injected once every 2 weeks, with the target dose being 500 µg. Subjects will receive an initial dose of 250 µg at Week 0, a medium dose of 350 µg at Week 2, a target dose of 500 µg at Week 4, and a maintenance dose of 500 µg from the subsequent week until Week 52. If the dose needs to be adjusted due to safety or tolerability consideration, it is allowed to be adjusted to the previous dose, but the target dose is preferred to be maintained during the treatment period.

Primary Outcome Measure

The phlebotomy- or erythrocytapheresis-free CHR rate based on the central laboratory test results evaluation [ Time Frame: Week 24 ]

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