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New treatment option for Primary Myelofibrosis
Official title P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
ClinicalTrials.gov ID: NCT06468033
What this study is testing
What is Ropeginterferon alfa-2b?
Ropeginterferon alfa-2b is an investigational medicine, given as an once-weekly, being studied as a potential treatment for primary myelofibrosis.
Also referred to as P1101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients aged ≥18 years at the time of signing the informed consent form;
- Patients with pre-fibrotic/early PMF (Pre-PMF) or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS plus, diagnosed...
- With good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR)...
- Hgb ≥10.0 g/dL at screening;
- Neutrophil count ≥1.0 × 10\^9/L at screening;
You likely can't join if
- Any known contraindications to interferon α or hypersensitivity to interferon α;
- Patients with prior interferon therapy having poor side effects or lack of how well it works to the previous interferon therapy per investigator\'s...
- Patients with an ongoing cytoreduction (e.g., HU or IFN-α) at the time of screening if, in the Investigator's opinion, randomizing them into the...
- With severe or serious diseases that, in the Investigator's opinion, may affect the patient's participation in this study;
- History of major organ transplantation;
- Pregnant or breastfeeding women;
See the full eligibility criteria
- Male or female patients aged ≥18 years at the time of signing the informed consent form;
- Patients with pre-fibrotic/early PMF (Pre-PMF) or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS plus, diagnosed according to WHO 2016 or 2022 classification;
- With good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin \>3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 ×...
- Hgb ≥10.0 g/dL at screening;
- Neutrophil count ≥1.0 × 10\^9/L at screening;
- Creatinine clearance rate ≥30 mL/min at screening (according to the Cockcroft-Gault formula);
- Females of childbearing potential, as well as all women \<2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females...
- Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
- Any known contraindications to interferon α or hypersensitivity to interferon α;
- Patients with prior interferon therapy having poor side effects or lack of how well it works to the previous interferon therapy per investigator\'s judgement;
- Patients with an ongoing cytoreduction (e.g., HU or IFN-α) at the time of screening if, in the Investigator's opinion, randomizing them into the placebo arm will lead to immediate rebound increase of peripheral blood...
- With severe or serious diseases that, in the Investigator's opinion, may affect the patient's participation in this study;
- History of major organ transplantation;
- Pregnant or breastfeeding women;
- Patients with any other diseases that will affect the study results or may weaken the compliance to protocol per the Investigator's judgment;
- Use any investigational drug \<4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug.
- Eligible for JAK inhibitor therapy at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Chūō, Yamanashi, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chūō, Yamanashi, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.