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An Open-label, Expanded Access Protocol for Pediatric Patients With Sickle Cell Disease Who Have No Alternative Treatment Options

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Trial Profile

An Open-label, Expanded Access Protocol for Pediatric Patients With Sickle Cell Disease Who Have No Alternative Treatment Options

Status: Discontinued
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 25 Nov 2024

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At a glance

  • Drugs Voxelotor (Primary)
  • Indications Sickle cell anaemia
  • Focus Expanded access; Therapeutic Use
  • Sponsors Pfizer

Most Recent Events

  • 25 Sep 2024 According to a Pfizer media release, status changed from recruiting to discontinued.
  • 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.
  • 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.

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