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A Phase 2, Open Label, Randomized, Dose Ranging, Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of AG-348 in Adult Patients With Pyruvate Kinase Deficiency

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Trial Profile

A Phase 2, Open Label, Randomized, Dose Ranging, Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of AG-348 in Adult Patients With Pyruvate Kinase Deficiency

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs Mitapivat (Primary) ; Mitapivat (Primary)
  • Indications Haemolytic anaemia; Pyruvate kinase deficiency of red cells
  • Focus Adverse reactions; Proof of concept
  • Acronyms DRIVE PK
  • Sponsors Agios Pharmaceuticals

    • Most Recent Events

    • 11 Jul 2024 This trial has been completed in France, according to European Clinical Trials Database record.
    • 05 Sep 2023 Planned End Date changed from 1 May 2025 to 1 Mar 2025.
    • 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

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