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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 2 → 73 locationsv5
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 150 to confirmed 160 · Study sites: 1 to 2 · Primary completion date: Sep 30, 2027 to Nov 18, 2027 · 1 morev4 Show 4 more changesShow less
    • Enrollment target: estimated 150 to confirmed 160
    • Study sites: 1 to 2
    • Primary completion date: Sep 30, 2027 to Nov 18, 2027
    • Completion date: Sep 30, 2028 to Jan 11, 2029
  3. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Mar 2027 to Sep 30, 2027 · Start date changed from estimate of Dec 2024 to Jul 18, 2025 · Study sites: 0 to 1 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Mar 2027 to Sep 30, 2027
    • Start date changed from estimate of Dec 2024 to Jul 18, 2025
    • Study sites: 0 to 1
    • Completion date: Apr 2028 to Sep 30, 2028
  4. Primary completion date: Jun 2026 to Mar 2027 Start date: Oct 2024 to Dec 2024 · Primary endpoints revised (6) · Completion date: Aug 2027 to Apr 2028 · 1 morev2 Show 4 more changesShow less
    • Start date: Oct 2024 to Dec 2024
    • Primary endpoints revised (6)
    • Completion date: Aug 2027 to Apr 2028
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06468033
Lead Sponsor PharmaEssentia
Conditions Primary Myelofibrosis, Myeloproliferative Neoplasm
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov