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A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 42 words Secondary endpoints: details revised at 1 of 12 entries · Site details revised at 1 of 3 sites Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 12 entries
    • Site details revised at 1 of 3 sites
  2. Recruitment opened Trial sites expanded: 0 → 3 locations · Start date changed from estimate of Aug 2026 to Jul 21, 2026v4 Show 2 more changesShow less
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Aug 2026 to Jul 21, 2026
  3. Re-verified, no change to tracked fieldsv3
  4. Completion pushed from Feb 2030 to Aug 2030v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 determine the effect of mitapivat versus placebo on the need for transfusions in subjects with SCD.
Trial Details
NCT Number NCT07656415
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Sickle Cell Disease
Enrollment 159 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov