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A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

Study acronym: ENERGIZEKids-T
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 3 to 4 Eligibility criteria expanded, about 22 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 22 words
  2. Study sites: 1 to 3v6
  3. Recruitment opened Study sites: 0 to 1v5 Show 1 more changeShow less
    • Study sites: 0 to 1
  4. 2 versions Re-verified since May 28, 2026, no change to tracked fieldsv3-v4
  5. Secondary endpoints revised (26)v2 See this version in full on ClinicalTrials.gov ↗
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this study is to compare the effect of mitapivat versus placebo on transfusion burden in pediatric participants with α- or β-transfusion-dependent thalassemia.
Trial Details
NCT Number NCT07506863
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov