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A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

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

Record History

  1. Primary completion date changed from estimate of Dec 31, 2024 to Jun 30, 2025 Completion date: Jul 31, 2025 to Jul 31, 2027v10 Show 1 more changeShow less
    • Completion date: Jul 31, 2025 to Jul 31, 2027
  2. Primary completion date: Jan 11, 2024 to Dec 31, 2024 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 100 to confirmed 111 · Completion date: Dec 28, 2025 to Jul 31, 2025 · 1 morev9 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 111
    • Completion date: Dec 28, 2025 to Jul 31, 2025
    • Site details revised at 23 of 23 sites
  3. Study sites revised (23)v8 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 3 of 23 sitesv7
  5. Study sites: 21 to 23v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 22 to 21 Eligibility criteria shortened, about 3 wordsv5 Show 1 more changeShow less
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Active, Not Recruiting to Recruiting Study sites: 21 to 22v4 Show 1 more changeShow less
    • Study sites: 21 to 22
  3. Enrollment target: 64 to 100 Primary endpoint revised · Study sites: 16 to 21 · Interventions: Ropeginterferon alfa-2b-njft (P1101) (Drug) to P1101 (Ropeginterferon alfa-2b-njft) (Drug), Ropeginterferon alfa-2b-njft (P1101) (Drug) · 2 morev3 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 16 to 21
    • Interventions: Ropeginterferon alfa-2b-njft (P1101) (Drug) to P1101 (Ropeginterferon alfa-2b-njft) (Drug), Ropeginterferon alfa-2b-njft (P1101) (Drug)
    • Eligibility criteria expanded, about 267 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Active, Not Recruiting Study sites: 0 to 16 · Start date changed from estimate of Sep 29, 2022 to Oct 26, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 16
    • Start date changed from estimate of Sep 29, 2022 to Oct 26, 2022
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
Trial Details
NCT Number NCT05481151
Lead Sponsor PharmaEssentia
Conditions Polycythemia Vera
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov