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Trial · NCT05031780

Registered outcomes40

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPhase 2: Percentage of Participants With Hemoglobin (Hb) ResponseWeek 12
PrimaryPhase 2: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious AEs (SAEs)Up to Week 12
PrimaryPhase 3: Percentage of Participants With Hb ResponseWeek 52
PrimaryPhase 3: Annualized Rate of Sickle Cell Pain Crises (SCPCs)Up to Week 52
SecondaryPhase 2: Change From Baseline in Hb ConcentrationBaseline, Week 10 up to Week 12
SecondaryPhase 2: Change From Baseline in Indirect BilirubinBaseline, Week 10 up to Week 12
SecondaryPhase 2: Change From Baseline in Lactate Dehydrogenase (LDH)Baseline, Week 10 up to Week 12
SecondaryPhase 2: Change From Baseline in Absolute Reticulocytes CountBaseline, Week 10 up to Week 12
SecondaryPhase 2: Change From Baseline in Percent ReticulocytesBaseline, Week 10 up to Week 12
SecondaryPhase 2: Change From Baseline in ErythropoietinBaseline, Week 10 up to Week 12
SecondaryPhase 2: Change From Baseline in Patient-Reported Outcomes Measurement Information System® (PROMIS®) Fatigue 13a Short Form (SF) ScoreBaseline, Week 10 up to Week 12
SecondaryPhase 2: Annualized Rate of SCPCsUp to Week 12
SecondaryPhase 2: Pharmacokinetic/Pharmacodynamic Relationship: Evaluate the Exposure of Mitapivat to the Change in Adenosine Triphosphate (ATP) and 2,3-Diphosphoglycerate (2,3-DPG)Day 1 up to Week 8
SecondaryPhase 2: Mitapivat Concentration Over TimeDay 1 up to Week 8
SecondaryPhase 2: Mitapivat Area Under the ConcentrationDay 1 up to Week 8
SecondaryPhase 2: Mitapivat Maximum (Peak) ConcentrationDay 1 up to Week 8
SecondaryPhase 3: Change From Baseline in Hb ConcentrationBaseline, Week 24 up to Week 52
SecondaryPhase 3: Change From Baseline in Indirect BilirubinBaseline, Week 24 up to Week 52
SecondaryPhase 3: Change From Baseline in Percent ReticulocytesBaseline, Week 24 up to Week 52
SecondaryPhase 3: Change From Baseline in PROMIS® Fatigue 13a SF ScoresBaseline, Week 24 up to Week 52

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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