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A Phase 1b Sequential Open Label Dose-Ranging Study of Safety, Pharmacokinetics, and Preliminary Activity of Benserazide in Subjects With Beta Thalassemia Intermedia and Sickle Cell Disease

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Trial Profile

A Phase 1b Sequential Open Label Dose-Ranging Study of Safety, Pharmacokinetics, and Preliminary Activity of Benserazide in Subjects With Beta Thalassemia Intermedia and Sickle Cell Disease

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 Apr 2024

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At a glance

  • Drugs Benserazide (Primary)
  • Indications Beta-thalassaemia; Sickle cell anaemia
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Phoenicia Biosciences

Most Recent Events

  • 01 Apr 2024 Planned End Date changed from 28 Feb 2024 to 28 Feb 2025.
  • 01 Apr 2024 Planned primary completion date changed from 31 Jan 2024 to 31 Dec 2024.
  • 20 Nov 2023 Minimum plasma drug concentration (Cmin) is removed from primary end-points. Sickle Cell Disease is added to indications.

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