A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection
Phase of Trial: Phase III
Latest Information Update: 25 Sep 2017
At a glance
- Drugs Sofosbuvir (Primary) ; Ribavirin
- Indications Hepatitis C
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Gilead Sciences
- 25 Sep 2017 According to a Gilead Sciences media release, the China Food and Drug Administration (CFDA) has approved Sovaldi (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.
- 16 Nov 2016 Status changed from active, no longer recruiting to completed.
- 26 Dec 2015 Planned End Date changed from 1 Oct 2016 to 1 Nov 2016 as reported by ClinicalTrial.gov record.