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P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

NCT06468033 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-08-13

No results posted yet for this study

Summary

This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk.

Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.

Conditions

  • Primary Myelofibrosis
  • Myeloproliferative Neoplasm

Interventions

BIOLOGICAL

Ropeginterferon alfa-2b

Pre-filled Syringe. Dosage: up to 500mcg

OTHER

Placebo

Placebo is a look-alike substance with the intervention (Ropeginterferon alfa-2b) that contains no active drug.

Sponsors & Collaborators

  • PharmaEssentia

    lead INDUSTRY

Principal Investigators

  • Toshiaki Sato, MD/PhD · PharmaEssentia JP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2027-09-30
Completion
2028-09-30
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 NCT06468033 on ClinicalTrials.gov