Actively Recruiting
P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
Led by PharmaEssentia · Updated on 2025-08-13
150
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at consent
- Diagnosed with pre-fibrotic/early PMF or overt PMF at low or intermediate-1 risk by DIPSS plus and WHO 2016 or 2022 criteria
- Good liver function with total bilirubin ≤1.5 × upper limit of normal, INR ≤1.5 × ULN, albumin >3.5 g/dL, ALT ≤2.0 × ULN, and AST ≤2.0 × ULN
- Hemoglobin level ≥10.0 g/dL
- Neutrophil count ≥1.0 × 10^9/L
- Creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
- Females of childbearing potential and women <2 years post-menopause must agree to birth control until 60 days after last dose and not breastfeed during study
- Able to provide informed consent and comply with study requirements
You will not qualify if you...
- Known contraindications or hypersensitivity to interferon alpha
- Prior interferon therapy with poor tolerance or lack of efficacy
- Ongoing cytoreduction therapy that may cause rebound blood count increase if randomized to placebo
- Severe or serious diseases that may affect study participation
- History of major organ transplantation
- Pregnant or breastfeeding women
- Other diseases that could affect study results or compliance
- Use of any investigational drug within 4 weeks before first dose or not recovered from prior investigational drug
- Eligible for JAK inhibitor therapy at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Yamanashi Hospital
Chūō, Yamanashi, Japan, 409-3898
Actively Recruiting
Research Team
S
Sandy Kan
CONTACT
A
Aypiin Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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