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Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Study acronym: SURPASS ET
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 65 to 67v13
  2. Primary completion date changed from estimate of Nov 30, 2024 to Nov 12, 2024 Completion date: Dec 30, 2025 to Aug 31, 2029 · Site details revised at 9 of 65 sitesv12 Show 2 more changesShow less
    • Completion date: Dec 30, 2025 to Aug 31, 2029
    • Site details revised at 9 of 65 sites
  3. Primary completion date: Dec 2023 to Nov 30, 2024 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 160 to confirmed 174 · Study sites: 61 to 65 · 5 morev11 Show 8 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 160 to confirmed 174
    • Study sites: 61 to 65
    • Completion date: Jan 2024 to Dec 30, 2025
    • Secondary endpoints shortened, about 63 words
    • Study description expanded, about 35 words
    • Collaborators shortened, about 6 words
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Feb 2023 to Dec 2023 Study sites: 60 to 61 · Completion date: Mar 2023 to Jan 2024 · Interventions: Ropeginterferon alfa-2b (Biological) to Anagrelide (Drug), Ropeginterferon alfa-2b (Biological) · 1 morev10 Show 4 more changesShow less
    • Study sites: 60 to 61
    • Completion date: Mar 2023 to Jan 2024
    • Interventions: Ropeginterferon alfa-2b (Biological) to Anagrelide (Drug), Ropeginterferon alfa-2b (Biological)
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 49 to 60 Primary completion date: Sep 2022 to Feb 2023 · Eligibility criteria expanded, about 71 wordsv9 Show 2 more changesShow less
    • Primary completion date: Sep 2022 to Feb 2023
    • Eligibility criteria expanded, about 71 words

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 4 of 49 sitesv8
  2. Primary endpoints revised (4) Eligibility criteria expanded, about 19 words · Secondary endpoints revised (10) · Site details revised at 34 of 49 sitesv7 Show 3 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (10)
    • Site details revised at 34 of 49 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 15 to 49 Start date: Aug 31, 2020 to Aug 25, 2020v6 Show 1 more changeShow less
    • Start date: Aug 31, 2020 to Aug 25, 2020
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 15 · Primary completion date: Aug 2022 to Sep 2022 · Start date changed from estimate of Aug 2020 to Aug 31, 2020v5 Show 3 more changesShow less
    • Study sites: 0 to 15
    • Primary completion date: Aug 2022 to Sep 2022
    • Start date changed from estimate of Aug 2020 to Aug 31, 2020
  5. Completion date: Sep 2022 to Mar 2023v4
  6. Start date: May 2020 to Aug 2020 Primary completion date: Feb 2022 to Aug 2022 · Completion date: Mar 2022 to Sep 2022v3 Show 2 more changesShow less
    • Primary completion date: Feb 2022 to Aug 2022
    • Completion date: Mar 2022 to Sep 2022
  7. Eligibility criteria shortened, about 5 wordsv2 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.
This is a Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of P1101 compared with ANA after 12 months of treatment as second-line therapy for subjects with ET who have had a suboptimal or failed response to HU.
Trial Details
NCT Number NCT04285086
Lead Sponsor PharmaEssentia
Conditions Essential Thrombocythemia
Enrollment 174 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov