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

Last updated: November 6, 2024
Sponsor: PharmaEssentia Japan K.K.
Overall Status: Active - Recruiting

Phase

3

Condition

Bone Marrow Disorder

Leukemia (Pediatric)

Red Blood Cell Disorders

Treatment

P1101 (Ropeginterferon alfa-2b)

Clinical Study ID

NCT04655092
A20-201
  • Ages > 20
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have completed the 52-week treatment duration in Study A19-201 and areconsidered by the investigator or sub investigator to be eligible for participationin this study

  • Patients who have given written informed consent to participate in this study

Exclusion

Exclusion Criteria:

  • Patients who are considered by the investigator or sub investigator to be ineligiblefor continued treatment with P1101

Study Design

Total Participants: 67
Treatment Group(s): 1
Primary Treatment: P1101 (Ropeginterferon alfa-2b)
Phase: 3
Study Start date:
January 19, 2021
Estimated Completion Date:
June 30, 2026

Study Description

The study is to evaluate the long-term safety and efficacy of P1101 in PV or ET patients who participated in Study A19-201 or Study P1101 ET. The subjects who have completed the 52-week P1101 treatment duration in Study A19-201 will start treatment with P1101 at the dose at Week 50. The subjects who have completed the follow-up/end-of-study visit in Study P1101 ET will start treatment with P1101 at the dose at Week 50. The subjects who were treated with anagrelide will start treatment with P1101 at a dose of 250 μg. The dose of P1101 during this study may be increased or decreased up to 500 μg depending on the condition.

Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.

Efficacy evaluations, safety assessments, and immunogenicity evaluations of P1101 will be performed.

Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling.

Connect with a study center

  • Ehime University Hospital

    Toon-shi, Ehime 791-0295
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu-shi, Mie
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita-shi, Osaka 565-0871
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • University of Yamanashi Hospital

    Chuo-shi, Yamanashi 409-3898
    Japan

    Active - Recruiting

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