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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2023

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At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary) ; Ribavirin; Sofosbuvir
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASTRAL-2
  • 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.
    • 01 Oct 2018 Results of a pooled analysis assessing patients reported outcomes from 11 studies, published in the Value in Health.
    • 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.

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