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A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

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

Record History

The 50 most recent of 55 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 10 words Secondary endpoints: details revised at 8 of 23 entries · Site details revised at 7 of 68 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 8 of 23 entries
    • Site details revised at 7 of 68 sites
  2. 17 versions Re-verified since Apr 23, 2025, no change to tracked fieldsv38-v54
  3. Study sites: 67 to 68v37
  4. Study sites: 69 to 67v36
  5. Results first posted: Jan 24, 2025 Study sites: 71 to 69 · Secondary endpoints: details revised at 1 of 23 entriesv35 Show 2 more changesShow less
    • Study sites: 71 to 69
    • Secondary endpoints: details revised at 1 of 23 entries
Show 29 earlier versionsHide 29 earlier versions
  1. Re-verified, no change to tracked fieldsv34
  2. Start date: Nov 8, 2021 to Dec 20, 2021 Site details revised at 10 of 71 sitesv33 Show 1 more changeShow less
    • Site details revised at 10 of 71 sites
  3. Re-verified, no change to tracked fieldsv32
  4. Study sites: 72 to 71v31
  5. 3 versions Re-verified since Mar 13, 2024, no change to tracked fieldsv28-v30
  6. Study sites: 73 to 72v27
  7. Re-verified, no change to tracked fieldsv26
  8. Primary completion date changed from estimate of Nov 2023 to Nov 13, 2023v25
  9. 2 versions Re-verified since Oct 11, 2023, no change to tracked fieldsv23-v24
  10. Study sites: 79 to 73v22
  11. Re-verified, no change to tracked fieldsv21
  12. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 171 to confirmed 194 · Study sites: 85 to 79 · Primary completion date: Dec 2023 to Nov 2023v20 Show 3 more changesShow less
    • Enrollment target: estimated 171 to confirmed 194
    • Study sites: 85 to 79
    • Primary completion date: Dec 2023 to Nov 2023
  13. Study sites: 86 to 85v19
  14. Site details revised at 5 of 86 sitesv18
  15. Study sites: 44 to 86 Completion date: Dec 2023 to Dec 2028 · Eligibility criteria expanded, about 28 wordsv17 Show 2 more changesShow less
    • Completion date: Dec 2023 to Dec 2028
    • Eligibility criteria expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  16. Study sites: 38 to 44v16
  17. Study sites: 27 to 38v15
  18. Study sites: 12 to 27v14
  19. Study sites: 7 to 12v13
  20. Re-verified, no change to tracked fieldsv12
  21. Study sites: 5 to 7v11
  22. Study sites: 4 to 5v10
  23. Study sites: 2 to 4 Start date changed from estimate of Nov 2021 to Nov 8, 2021v9 Show 1 more changeShow less
    • Start date changed from estimate of Nov 2021 to Nov 8, 2021
  24. Study sites: 1 to 2 Primary and study completion dates: Oct 2023 to Dec 2023 · Start date: Oct 2021 to Nov 2021v8 Show 2 more changesShow less
    • Primary and study completion dates: Oct 2023 to Dec 2023
    • Start date: Oct 2021 to Nov 2021
  25. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Sep 2021 to Oct 2021v7 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Sep 2021 to Oct 2021
  26. Re-verified, no change to tracked fieldsv6
  • 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 purpose of this study was to compare the effect of mitapivat versus placebo on hemolytic anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT).
Trial Details
NCT Number NCT04770753
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Enrollment 194 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov