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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2023

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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

    • 01 May 2023 Results of pooled analysis (n=1151) assessing the safety and tolerability of sofosbuvir/velpatasvir for the treatment of hepatitis C virus infection in three Phase 3 registrational studies (ASTRAL-1, NCT02201940; ASTRAL-2, NCT02220998; ASTRAL-3, NCT02201953) in patients with and without compensated cirrhosis, published in the Journal of Viral Hepatitis.
    • 08 Nov 2022 Results of post-hoc analysis of Phase 3 trials with SOF/VEL 12 weeks without ribavirin (RBV) (ASTRAL 1-5, and POLARIS4) presented at The Liver Meeting 2022: 73rd Annual Meeting of the American Association for the Study of Liver Diseases
    • 01 Oct 2018 Results of a pooled analysis assessing patients reported outcomes from 11 studies, published in the Value in Health.

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