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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients With Sickle Cell Disease

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients With Sickle Cell Disease

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 24 Nov 2024

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At a glance

  • Drugs Voxelotor (Primary) ; Antianaemics
  • Indications Leg ulcer; Sickle cell anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms RESOLVE
  • Sponsors Global Blood Therapeutics; Pfizer

Most Recent Events

  • 25 Sep 2024 According to a Pfizer media release, status changed from active, no longer recruiting to discontinued.
  • 25 Sep 2024 According to a Pfizer media release, the company has notified regulatory authorities about the clinical findings and its decision to voluntarily discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.
  • 25 Sep 2024 According to a Pfizer media release, Pfizer is discontinuing all active voxelotor clinical trials and expanded access programs worldwide, based on the totality of clinical data that now indicates the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population.

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