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A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Mar 31, 2027 to May 9, 2025v10
  2. Primary completion date: Jul 29, 2024 to Mar 31, 2027 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 64 to confirmed 91 · Completion date: Dec 31, 2026 to Mar 31, 2027 · 1 morev9 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 64 to confirmed 91
    • Completion date: Dec 31, 2026 to Mar 31, 2027
    • Site details revised at 34 of 34 sites
  3. Site details revised at 2 of 34 sitesv8
  4. Study sites: 37 to 34v7
  5. Site details revised at 6 of 37 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 4 of 37 sitesv5
  2. Study sites: 27 to 37 Eligibility criteria expanded, about 348 words · Study description expanded, about 1 wordv4 Show 2 more changesShow less
    • Eligibility criteria expanded, about 348 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 23 to 27v3
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 23 · Start date changed from estimate of Jul 29, 2022 to Sep 29, 2022 · Study title shortened, about 6 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 23
    • Start date changed from estimate of Jul 29, 2022 to Sep 29, 2022
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia
Trial Details
NCT Number NCT05482971
Lead Sponsor PharmaEssentia
Conditions Essential Thrombocythemia
Enrollment 91 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov