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An Open-Label Study To Evaluate the Efficacy and Safety of AG-348 in Regularly Transfused Adult Subjects With Pyruvate Kinase (PK) Deficiency

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Trial Profile

An Open-Label Study To Evaluate the Efficacy and Safety of AG-348 in Regularly Transfused Adult Subjects With Pyruvate Kinase (PK) Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2023

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At a glance

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

    • Most Recent Events

    • 15 Jun 2023 Results assessing long-term data from ACTIVATE-T and its LTE presented at the 28th Congress of the European Haematology Association
    • 11 May 2023 According to an Agios Pharmaceuticals Media Release, data from this trial will be presented at the 2023 European Hematology Association (EHA) Annual Meeting.
    • 13 Dec 2022 Results of the long-term extension (LTE) study (NCT03853798) assessing the long term Hb response and reduction in transfusion burden are maintained in patients with pyruvate kinase deficiency treated with mitapivat from ACTIVATE and ACTIVATE-T studies, presented at the 64th American Society of Hematology Annual Meeting and Exposition.
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