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A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period

Study acronym: ACTIVATE-KidsT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 23 words Secondary endpoints: details revised at 3 of 26 entries · Site details revised at 8 of 22 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 3 of 26 entries
    • Site details revised at 8 of 22 sites
  2. 15 versions Re-verified since Jun 19, 2025, no change to tracked fieldsv33-v47
  3. Study arms: 3 to 2v32
  4. 7 versions Re-verified since Jun 12, 2024, no change to tracked fieldsv25-v31
  5. Study sites: 23 to 22 Primary completion date changed from estimate of May 2024 to May 3, 2024v24 Show 1 more changeShow less
    • Primary completion date changed from estimate of May 2024 to May 3, 2024
Show 22 earlier versionsHide 22 earlier versions
  1. 4 versions Re-verified since Jan 17, 2024, no change to tracked fieldsv20-v23
  2. Completion date: May 2024 to Jun 2029 Eligibility criteria expanded, about 11 words · Secondary endpoints revised (26)v19 Show 2 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (26)

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 45 to confirmed 49 · Primary and study completion dates: Feb 2025 to May 2024 · Site details revised at 23 of 23 sitesv18 Show 3 more changesShow less
    • Enrollment target: estimated 45 to confirmed 49
    • Primary and study completion dates: Feb 2025 to May 2024
    • Site details revised at 23 of 23 sites
  4. Study sites: 21 to 23v17
  5. Study sites: 19 to 21v16
  6. Study sites: 17 to 19v15
  7. Study sites: 15 to 17v14
  8. Study sites: 13 to 15v13
  9. Study sites: 8 to 13v12
  10. Primary and study completion dates: Nov 1, 2024 to Feb 2025v11
  11. Study sites: 5 to 8v10
  12. 2 versions Re-verified since Oct 19, 2022, no change to tracked fieldsv8-v9
  13. Study sites: 4 to 5 Completion date: Nov 1, 2029 to Nov 1, 2024v7 Show 1 more changeShow less
    • Completion date: Nov 1, 2029 to Nov 1, 2024
  14. Study sites: 3 to 4v6
  15. Re-verified, no change to tracked fieldsv5
  16. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Apr 2022 to Jun 8, 2022v4 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Apr 2022 to Jun 8, 2022
  17. Start date: Mar 1, 2022 to Apr 2022v3
  18. Secondary endpoints: 21 to 26v2 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.
ACTIVATE-KidsT (AG348-C-022) is a multicenter study designed to evaluate the efficacy and safety of treatment with mitapivat compared with placebo in pediatric participants with pyruvate kinase deficiency (PK deficiency) who are regularly receiving blood transfusions. Participants will be randomized 2:1 to receive either mitapivat or matching placebo. Randomization will be stratified by age (1 to \< 6 years, 6 to \< 12 years, 12 to \< 18 years) and splenectomy status. Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 24-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat in the open-label extension (OLE) period.
Trial Details
NCT Number NCT05144256
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov