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P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
Sponsor: PharmaEssentia
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
Ropeginterferon alfa-2b
Pre-filled Syringe. Dosage: up to 500mcg
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