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A Phase II, Single Arm, Multicenter, Proof-of-Mechanism Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bitopertin (RO4917838) in Adults With Non-Transfusion-Dependent Βeta-Thalassemia

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Trial Profile

A Phase II, Single Arm, Multicenter, Proof-of-Mechanism Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bitopertin (RO4917838) in Adults With Non-Transfusion-Dependent Βeta-Thalassemia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 May 2019

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At a glance

  • Drugs Bitopertin (Primary)
  • Indications Beta-thalassaemia
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Roche
  • Most Recent Events

    • 16 May 2019 This trial has been discontinued in Italy, according to European Clinical Trials Database.
    • 04 Dec 2018 Results assessing efficacy and safety of Bitopertin in patients with beta-thalassemia, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology.
    • 13 Aug 2018 Status changed from active, no longer recruiting to completed.

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