To hear about similar clinical trials, please enter your email below
Trial Title:
P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk
NCT ID:
NCT06468033
Condition:
Primary Myelofibrosis
Myeloproliferative Neoplasm
Conditions: Official terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Conditions: Keywords:
P1101
Primary Myelofibrosis
PMF
Ropeginterferon
PharmaEssentia
Myeloproliferative neoplasms
MPN
Pre-fibrotic
Low or Intermediate-1 Risk
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
Double-Blind
Intervention:
Intervention type:
Biological
Intervention name:
Ropeginterferon alfa-2b
Description:
Pre-filled Syringe.
Dosage: up to 500mcg
Arm group label:
Ropeginterferon alfa-2b (P1101)
Other name:
P1101
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo is a look-alike substance with the intervention (Ropeginterferon alfa-2b) that
contains no active drug.
Arm group label:
Placebo control
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female patients aged ≥18 years at the time of signing the informed consent
form;
2. 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;
3. 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 × ULN, and aspartate
aminotransferase (AST) ≤2.0 × ULN;
4. Hgb ≥10.0 g/dL at screening;
5. Neutrophil count ≥1.0 × 10^9/L at screening;
6. Creatinine clearance rate ≥30 mL/min at screening (according to the Cockcroft-Gault
formula);
7. 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 must agree to not breastfeed
during the study;
8. Written informed consent obtained from the subject and ability for the subject to
comply with the requirements of the study.
Exclusion Criteria:
1. Any known contraindications to interferon α or hypersensitivity to interferon α;
2. Patients with prior interferon therapy having poor tolerability or lack of efficacy
to the previous interferon therapy per investigator's judgement;
3. 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 counts and thus may jeopardize
their health status;
4. With severe or serious diseases that, in the Investigator's opinion, may affect the
patient's participation in this study;
5. History of major organ transplantation;
6. Pregnant or breastfeeding women;
7. Patients with any other diseases that will affect the study results or may weaken
the compliance to protocol per the Investigator's judgment;
8. 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.
9. Eligible for JAK inhibitor therapy at screening.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 2024
Completion date:
April 2028
Lead sponsor:
Agency:
PharmaEssentia
Agency class:
Industry
Source:
PharmaEssentia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06468033
