NCT02021643

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 687 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C virus (HCV) infection.

Conditions

• Chronic HCV Infection

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg tablet administered orally once daily
DRUG	RBV	Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUG	PEG	Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week

Timeline

• Start date: 2013-12-10
• Primary completion: 2016-08-12
• Completion: 2016-11-03
• First posted: 2013-12-27
• Last updated: 2018-02-20
• Results posted: 2018-02-20

Locations

35 sites across 5 countries: China, Hong Kong, South Korea, Taiwan, Vietnam