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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase Deficiency Who Are Regularly Transfused, Followed by a 5-Year Open-label Extension Period

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase Deficiency Who Are Regularly Transfused, Followed by a 5-Year Open-label Extension Period

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

Latest Information Update: 19 Feb 2025

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At a glance

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

    • Most Recent Events

    • 13 Feb 2025 According to Agios Pharmaceuticals media release, the company plans to present more detailed analysis from this study at upcoming medical conferences.
    • 13 Feb 2025 According to Agios Pharmaceuticals media release, based on the clinically meaningful results observed in both the ACTIVATE-Kids and ACTIVATE-KidsT Phase 3 studies, the company intends to submit a marketing application for mitapivat in pediatric patients with PK deficiency.
    • 01 Aug 2024 According to an Agios Pharmaceuticals media release, Rachael F. Grace is the investigator of this study.

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