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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

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: 09 Aug 2022

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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

    • 17 Jun 2022 Results (n=90; data cut-off 4 Mar 2021) assessing bone mineral density over time in a broad pyruvate kinase deficiency population (independent of transfusion) receiving long-term treatment with mitapivat in patients enrolled from DRIVE-PK (NCT02476916), ACTIVATE (NCT03548220), ACTIVATE-T (NCT03559699), and the long-term extension (LTE) of ACTIVATE and ACTIVATE-T (NCT03853798), presented at the 27th Congress of the European Haematology Association.
    • 14 Dec 2021 Results of pooled analysis assessing BMD over time in a broader PK deficiency population including both non-regularly transfused and regularly transfused pts receiving long-term treatment with mitapivat from DRIVE-PK (NCT02476916), ACTIVATE (NCT03548220), ACTIVATE-T (NCT03559699), and the long-term extension (LTE) study (NCT03853798) presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 04 Nov 2021 According to an Agios Pharmaceuticals media release, the company will host a virtual investor event on Dec. 14, 2021 to review the key clinical oral and poster presentations from the ASH meeting.
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