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

NCT04655092 | Recruiting Phase 3 FDA Drug

• 1 other identifier: A20-201
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Polycythemia Vera (PV)

Keywords

Myeloproliferative Neoplasms

Outcome Measures

Primary Outcomes (1)

• Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks

  CHR will be defined as follows. * Hematocrit \<45% phlebotomy-free (absence of phlebotomy during the previous 12 weeks) * Platelet count ≤ 400 x 10\^9/L * WBC count ≤ 10 x 10\^9/L

  Through study completion, an average of 2 year

Secondary Outcomes (8)

• Changes in hematocrit every 52 weeks over time

  Through study completion, an average of 2 year

• Changes in white blood cell every 52 weeks over time

  Through study completion, an average of 2 year

• Changes in platelet count every 52 weeks over time

  Through study completion, an average of 2 year

• Changes in red blood cell count every 52 weeks over time

  Through study completion, an average of 2 year

• Changes in spleen size every 52 weeks over time

  Through study completion, an average of 2 year

Other Outcomes (1)

• Bone marrow histological remission (optional)

  Through study completion, an average of 2 year

Study Arms (1)

P1101 (Ropeginterferon alfa-2b)

EXPERIMENTAL

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.

Biological: P1101 (Ropeginterferon alfa-2b)

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.

P1101 (Ropeginterferon alfa-2b)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study
• Patients who have given written informed consent to participate in this study

You may not qualify if:

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

Sponsors & Collaborators

• PharmaEssentia Japan K.K.: lead

Study Sites (6)

Ehime University Hospital

Toon-shi, Ehime, 791-0295, Japan

RECRUITING

Mie University Hospital

Tsu, Mie-ken, Japan

RECRUITING

Osaka University Hospital

Suita-shi, Osaka, 565-0871, Japan

RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

RECRUITING

University of Yamanashi Hospital

Chuo-shi, Yamanashi, 409-3898, Japan

RECRUITING

MeSH Terms

Conditions

Polycythemia Vera; Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Keita Kirito, MD

  University of Yamanashi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hiroaki Kawase

CONTACT

+81-3-6910-5103; hiroaki_kawase@pharmaessentia.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Conventional treatment based on phlebotomies, low-dose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of P1101 (ropeginterferon alfa-2b) once every 2 weeks

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 7, 2020
• Study Start: January 19, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (6)