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
Phase of Trial: Phase III
Latest Information Update: 09 May 2017
At a glance
- Drugs Sofosbuvir/velpatasvir (Primary)
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ASTRAL-1
- Sponsors Gilead Sciences
- 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.
- 08 Jul 2016 According to a Gilead Sciences media release, the European Commission has granted marketing authorization for Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection in June 2016.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History