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Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Pharmacokinetic Study of ACTIMMUNE® (Interferon γ-1b) in Children and Young Adults With Friedreich's Ataxia

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Trial Profile

Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Pharmacokinetic 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: 23 Dec 2024

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At a glance

  • Drugs Interferon gamma-1b (Primary)
  • Indications Friedreich's ataxia
  • Focus Registrational; Therapeutic Use
  • Acronyms STEADFAST
  • Sponsors Amgen; Horizon Therapeutics plc

    • Most Recent Events

    • 08 Dec 2016 According to a Horizon Pharma media release, the company will continue to work with FARA and the principal investigator to further analyze the data to help inform future research efforts as well as future data presentation or publication.
    • 08 Dec 2016 Status changed from active, no longer 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 trial results, the FA (Friedreich's ataxia) development program will be discontinued.
    • 08 Dec 2016 Results published in a Horizon Pharma media release.

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