RecruitingPhase 3NCT06468033

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

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study


Sponsor

PharmaEssentia

Enrollment

150 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a biological treatment called Ropeginterferon alfa-2b for people with myeloproliferative neoplasm and primary myelofibrosis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRopeginterferon alfa-2b

Pre-filled Syringe. Dosage: up to 500mcg

OTHERPlacebo

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


Locations(1)

University of Yamanashi Hospital

Chūō, Yamanashi, Japan

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NCT06468033


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