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

Study acronym: ENERGIZE-T
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 9 words Secondary endpoints: details revised at 7 of 19 entries · Site details revised at 12 of 75 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 7 of 19 entries
    • Site details revised at 12 of 75 sites
  2. 15 versions Re-verified since Jun 19, 2025, no change to tracked fieldsv40-v54
  3. Results first posted: May 25, 2025 Secondary endpoints: details revised at 1 of 19 entriesv39 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 19 entries
  4. Study sites: 78 to 75 Eligibility criteria expanded, about 24 wordsv38 Show 1 more changeShow less
    • Eligibility criteria expanded, about 24 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study Identification, Study Status, Oversightv37
Show 31 earlier versionsHide 31 earlier versions
  1. Study Identification, Study Status, Oversightv36
  2. 4 versions Re-verified since Jun 12, 2024, no change to tracked fieldsv32-v35
  3. Primary completion date changed from estimate of Apr 2024 to Apr 11, 2024v31
  4. 2 versions Re-verified since Mar 13, 2024, no change to tracked fieldsv29-v30
  5. Primary completion date: Jul 2024 to Apr 2024v28
  6. 3 versions Re-verified since Oct 11, 2023, no change to tracked fieldsv25-v27
  7. Study sites: 82 to 78 Primary completion date: Apr 2024 to Jul 2024v24 Show 1 more changeShow less
    • Primary completion date: Apr 2024 to Jul 2024
  8. Re-verified, no change to tracked fieldsv23
  9. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 240 to confirmed 258 · Study sites: 91 to 82 · Primary completion date: Jun 2024 to Apr 2024v22 Show 3 more changesShow less
    • Enrollment target: estimated 240 to confirmed 258
    • Study sites: 91 to 82
    • Primary completion date: Jun 2024 to Apr 2024
  10. Study sites: 92 to 91v21
  11. Study sites: 91 to 92v20
  12. Site details revised at 5 of 91 sitesv19
  13. Study sites: 49 to 91 Completion date: Jun 2024 to Jun 2029 · Eligibility criteria expanded, about 28 wordsv18 Show 2 more changesShow less
    • Completion date: Jun 2024 to Jun 2029
    • Eligibility criteria expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 42 to 49v17
  15. Study sites: 33 to 42v16
  16. Study sites: 18 to 33v15
  17. Study sites: 11 to 18v14
  18. Study sites: 9 to 11v13
  19. Study sites: 5 to 9v12
  20. 2 versions Re-verified since Jan 13, 2022, no change to tracked fieldsv10-v11
  21. Study sites: 3 to 5 Start date changed from estimate of Nov 2021 to Nov 30, 2021v9 Show 1 more changeShow less
    • Start date changed from estimate of Nov 2021 to Nov 30, 2021
  22. Study sites: 1 to 3 Completion date: Jul 2024 to Jun 2024 · Start date: Oct 2021 to Nov 2021v8 Show 2 more changesShow less
    • Completion date: Jul 2024 to Jun 2024
    • Start date: Oct 2021 to Nov 2021
  23. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Completion date: Jun 2024 to Jul 2024 · Start date: Sep 2021 to Oct 2021v7 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Completion date: Jun 2024 to Jul 2024
    • Start date: Sep 2021 to Oct 2021
  24. 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 objective of this study was to compare the effect of mitapivat versus placebo on transfusion burden in participants with α- or β-transfusion-dependent thalassemia.
Trial Details
NCT Number NCT04770779
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
Enrollment 258 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov