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Long-Term Safety Extension Study of ACTIMMUNE (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

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Trial Profile

Long-Term Safety Extension Study of ACTIMMUNE (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Interferon gamma-1b (Primary)
  • Indications Friedreich's ataxia
  • Focus Adverse reactions
  • Acronyms STEADFAST Long-Term Safety Extension
  • Sponsors Horizon Therapeutics plc
  • Most Recent Events

    • 24 Feb 2017 Planned End Date changed from 1 Jun 2018 to 1 Jun 2017.
    • 24 Feb 2017 Planned primary completion date changed from 1 Jun 2018 to 1 Jun 2017.
    • 08 Dec 2016 Status changed from recruiting to discontinued. According to a Horizon Pharma media release, the company in conjunction with the independent Data Safety Monitoring Board, the principal investigator and the Friedreich's Ataxia Research Alliance (FARA) Collaborative Clinical Research Network (CCRN) in FA, has determined that, based on the results from a parent phase III study (profile 700251922), the FA (Friedreich's ataxia) development program will be discontinued.

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