A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2018

At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASTRAL-1
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 30 May 2018 According to a Gilead Sciences media release, China Drug Administration approved EPCLUSA for the treatment of adults with genotype 1-6 chronic hepatitis C virus infection based on results from five international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4 and ASTRAL-5.
    • 09 May 2017 Results (n=123) of a retrospective analysis evaluating the safety and efficacy of sofosbuvir/velpatasvir in patients aged 65 and older with HCV GT 1-6 from ASTRAL 1, 2 & 3 studies, presented at the Digestive Disease Week 2017.
    • 14 Jul 2016 According to a Gilead Sciences, Health Canada has issued a Notice of Compliance approving EPCLUSA (sofosbuvir/velpatasvir) for the treatment of adults with genotype 1-6 chronic HCV based on results from ASTRAL 1-4 trials.
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