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

NCT04655092 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-11-08

No results posted yet for this 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.

Conditions

  • Polycythemia Vera (PV)

Interventions

BIOLOGICAL

P1101 (Ropeginterferon alfa-2b)

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.

Sponsors & Collaborators

  • PharmaEssentia Japan K.K.

    lead INDUSTRY

Principal Investigators

  • Keita Kirito, MD · University of Yamanashi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04655092 on ClinicalTrials.gov