Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients

Sponsor
PharmaEssentia Japan K.K.
Study ID
NCT04655092
Phase
PHASE3
Status
Recruiting
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Conditions

  • Polycythemia Vera (PV)

Eligibility Criteria

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

Interventions

  • P1101 (Ropeginterferon alfa-2b) — BIOLOGICAL
    The subjects who have completed the 52-week treatment duration in Study A19-201 will be treated with P1101, starting at the dose at Week 50. The dose during this study may be increased or decreased up to 500 μg depending on the condition. This study will be continued as a post-marketing clinical study after acquisition of the marketing approval of P1101.

Study Details

This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.

Key Dates

Start date
Jan 19, 2021
Status verified
Nov 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
67 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: P1101 (Ropeginterferon alfa-2b)
    Conventional treatment based on phlebotomies, lowdose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of pegylated prolineinterferon alpha-2b (P1101, Ropeginterferon alfa-2b) once every 2 weeks.

Primary Outcome Measure

Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks [ Time Frame: Through study completion, an average of 2 year ]

Central Contacts

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