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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2024

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At a glance

  • Drugs Mitapivat (Primary)
  • Indications Pyruvate kinase deficiency of red cells
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTIVATE
  • Sponsors Agios Pharmaceuticals

    • Most Recent Events

    • 12 Dec 2023 Results of post hoc analysis (n=80 from studies NCT03548220 and NCT03853798) assessing the impact of PK deficiency on work or school performance and how treatment with mitapivat impacts this over time in these pts presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 15 Jun 2023 Results assessing changes in Hb and hemolysis after mitapivat treatment in adult pts with PK deficiency and baseline Hb>10 g/dL who were not regularly transfused and enrolled in the DRIVE-PK and ACTIVATE/LTE of presented at the 28th Congress of the European Haematology Association
    • 11 May 2023 According to an Agios Pharmaceuticals Media Release, Sub-Analysis data from this trial will be presented at the 2023 European Hematology Association (EHA) Annual Meeting.

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