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A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 4 → 1 primary endpoints
See other at-risk trials from Agios Pharmaceuticals, Inc.

Record History

  1. Eligibility criteria expanded, about 8 words
  2. Primary endpoint(s) modified Enrollment increased: 6 → 59 participants · Trial sites expanded: 4 → 23 locations · Eligibility criteria shortened, about 36 words · 2 morev36 Show 5 more changesShow less
    • Enrollment increased: 6 → 59 participants
    • Trial sites expanded: 4 → 23 locations
    • Eligibility criteria shortened, about 36 words
    • Secondary endpoints expanded, about 52 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. 14 versions Re-verified since Feb 26, 2025, no change to tracked fieldsv22-v35
  4. Start date: Jul 5, 2023 to Jul 6, 2023v21
  5. 6 versions Re-verified since Jul 11, 2024, no change to tracked fieldsv15-v20
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 3 to 4v14
  2. Site details revised at 1 of 3 sitesv13
  3. 2 versions Re-verified since Mar 13, 2024, no change to tracked fieldsv11-v12
  4. Study sites: 2 to 3v10
  5. 3 versions Re-verified since Nov 13, 2023, no change to tracked fieldsv7-v9
  6. Study sites: 1 to 2v6
  7. Trial status: Not Yet Recruiting to Enrolling by Invitation Enrollment target: 10 to 6 · Study sites: 4 to 1 · Start date changed from estimate of Jun 2023 to Jul 5, 2023v5 Show 3 more changesShow less
    • Enrollment target: 10 to 6
    • Study sites: 4 to 1
    • Start date changed from estimate of Jun 2023 to Jul 5, 2023
  8. 3 versions Re-verified since Apr 13, 2023, no change to tracked fieldsv2-v4
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of the study is to provide continued access to participants who are deriving clinical benefit from ongoing mitapivat treatment in an Agios-sponsored mitapivat study, in the opinion of the Investigator.
Trial Details
NCT Number NCT05777993
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Pyruvate Kinase Deficiency, Anemia, Hemolytic, Sickle Cell Disease, Thalassemia
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov