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

Part of paid clinical trials in Los Angeles, California.

Sponsor
PharmaEssentia
Study ID
NCT06468033
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Myeloproliferative Neoplasm
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ropeginterferon alfa-2b — BIOLOGICAL
    Pre-filled Syringe. Dosage: up to 500mcg
  • Placebo — OTHER
    Placebo is a look-alike substance with the intervention (Ropeginterferon alfa-2b) that contains no active drug.

Study Details

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.

Key Dates

First listed
Jun 21, 2024
Start date
Jul 18, 2025
Status verified
Jul 2026
Primary completion
Nov 18, 2027
Completion
Jan 11, 2029

Study Design

Enrollment
160 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ropeginterferon alfa-2b (P1101)
    Ropeginterferon alfa-2b (P1101) is administrated subcutaneously (SC) every two weeks (± 3 days) until 80 weeks.
  • Placebo Comparator: Placebo control
    Placebo is administrated subcutaneously (SC) every two weeks (± 3 days) until 80 weeks.

Primary Outcome Measure

Number of Participants with Platelet count equal or less (≤) 400 × 10^9/L [ Time Frame: 80 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
University of Kansas Medical Center (KUMC)Kansas CityKansas66103-
American Oncology Partners of Maryland PA (Center for Cancer and Blood Disorders)BethesdaMaryland20817-
Washington University School of MedicineSt LouisMissouri63110-
Weill Medical College of Cornell UniversityNew YorkNew York10021-
Stony Brook University Medical CenterStony BrookNew York11794-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke UniversityDurhamNorth Carolina27710-
Ohio State UniversityColumbusOhio43210-
MD Anderson Cancer CenterHoustonTexas77030-
Virginia Commonwealth UniversityRichmondVirginia23284-
University of Washington Medical Center - Fred Hutchinson Cancer CenterSeattleWashington98195-

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAGeorgetown University Medical Center· Washington D.C., DCUniversity of Kansas Medical Center (KUMC)· Kansas City, KSAmerican Oncology Partners of Maryland PA (Center for Cancer and Blood Disorders)· Bethesda, MDWashington University School of Medicine· St Louis, MOWeill Medical College of Cornell University· New York, NY

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