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
Price :
$35
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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
- 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