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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jan 2016

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

    • 04 Jan 2016 The US FDA has granted priority review (January 2016) to the company's NDA and has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016, according to a Gilead Sciences media release.
    • 04 Dec 2015 According to a Gilead Sciences media release, the company's MAA for sofosbuvir/velpatasvir for the treatment of chronic hepatitis C virus infection has been fully validated and is now under assessment by the European Medicines Agency (EMA).
    • 16 Nov 2015 Primary endpoint has been met. (Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)), as per results published in the New England Journal of Medicine.
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