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A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

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Trial Profile

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Sofosbuvir/velpatasvir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ASTRAL-4
  • 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.
  • 14 Apr 2018 Results assessing survival benefits of sofosbuvir-based DAA regimens in four studies (GS-US334-0125, SOLAR-1, -2 and ASTRAL-4; n=492) presented at The International Liver Congress 2018
  • 10 Mar 2018 Results of integrated retrospective analysis of SOLAR-1, SOLAR-2, ASTRAL-4, and GS-US-334-0125 trials identifying predictive factors for treatment benefits and adverse events published in the Gastroenterology

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