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A Phase I/II, Intra-Patient Dose-Escalation Study of the Selective GlyT1 Inhibitor, Bitopertin for Steroid-Refractory Diamond-Blackfan Anemia

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Trial Profile

A Phase I/II, Intra-Patient Dose-Escalation Study of the Selective GlyT1 Inhibitor, Bitopertin for Steroid-Refractory Diamond-Blackfan Anemia

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Aug 2023

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At a glance

  • Drugs Bitopertin (Primary)
  • Indications Diamond-Blackfan syndrome
  • Focus Therapeutic Use

Most Recent Events

  • 09 Dec 2024 According to abstract published in 65th American Society of Hematology Annual Meeting and Exposition ,this study has been granted an FDA IND (165778) and is open for enrollment. It is monitored under the NIH Institutional Review Board (001528-H) and is registered with the U.S. National Library of Medicine
  • 27 Jul 2023 According to a Disc Medicine media release, the first patient has been enrolled in the National Institutes of Health-sponsored Phase 1/2 clinical trial of bitopertin
  • 25 Jul 2023 Planned initiation date (estimated date for recruitment of the first subject) changed from 2 Jul 2023 to 31 Jul 2023.

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