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RECRUITING
NCT06468033
PHASE3

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

Sponsor: PharmaEssentia

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-07-18

Completion Date

2028-09-30

Last Updated

2025-08-13

Healthy Volunteers

No

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.

Locations (1)

University of Yamanashi Hospital

Chūō, Yamanashi, Japan