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A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

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

Record History

The 50 most recent of 51 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 19 versions Re-verified since Feb 24, 2025, no change to tracked fieldsv33-v51
  2. Primary completion date changed from estimate of Dec 2024 to Dec 13, 2024v32
  3. 2 versions Re-verified since Nov 14, 2024, no change to tracked fieldsv30-v31
  4. Primary completion date: Oct 2024 to Dec 2024v29
  5. Re-verified, no change to tracked fieldsv28
Show 26 earlier versionsHide 26 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 21 to 19v27 Show 1 more changeShow less
    • Study sites: 21 to 19
  2. 3 versions Re-verified since May 13, 2024, no change to tracked fieldsv24-v26
  3. Study sites: 20 to 21v23
  4. 3 versions Re-verified since Jan 17, 2024, no change to tracked fieldsv20-v22
  5. Completion date: Oct 2024 to Jan 2030 Eligibility criteria expanded, about 10 words · Secondary endpoints revised (28)v19 Show 2 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints revised (28)

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv18
  7. Study sites: 17 to 20 Primary and study completion dates: Jun 2024 to Oct 2024v17 Show 1 more changeShow less
    • Primary and study completion dates: Jun 2024 to Oct 2024
  8. Study sites: 15 to 17v16
  9. Re-verified, no change to tracked fieldsv15
  10. Study sites: 14 to 15v14
  11. Study sites: 13 to 14v13
  12. Study sites: 9 to 13v12
  13. Study sites: 8 to 9 Primary and study completion dates: Oct 2024 to Jun 2024v11 Show 1 more changeShow less
    • Primary and study completion dates: Oct 2024 to Jun 2024
  14. Study sites: 6 to 8v10
  15. 2 versions Re-verified since Oct 19, 2022, no change to tracked fieldsv8-v9
  16. Study sites: 2 to 6v7
  17. Study sites: 1 to 2v6
  18. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2022 to Jun 6, 2022 · Site details revisedv5 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2022 to Jun 6, 2022
    • Site details revised
  19. Study sites: 0 to 1v4
  20. Start date: Apr 2022 to Jun 2022v3
  21. Start date: Mar 1, 2022 to Apr 2022 Primary completion date: Oct 1, 2024 to Oct 2024 · Completion date: Oct 1, 2029 to Oct 2024v2 Show 2 more changesShow less
    • Primary completion date: Oct 1, 2024 to Oct 2024
    • Completion date: Oct 1, 2029 to Oct 2024
  • 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.
Study ACTIVATE-Kids (AG348-C-023) will evaluate the efficacy and safety of orally administered mitapivat as compared with placebo in pediatric participants with pyruvate kinase deficiency (PKD) who are not 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). Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 12-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat for up to 5 years in the open-label extension (OLE) period.
Trial Details
NCT Number NCT05175105
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov