NCT01826981

Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 359 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	LDV/SOF	Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
DRUG	SOF	SOF 400 mg tablet administered orally once daily
DRUG	RBV	Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUG	Peg-IFN	pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
DRUG	GS-9669	GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily
DRUG	VEL	Velpatasvir (VEL) tablet(s) administered orally once daily

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2013-04-09
• Last updated: 2018-11-16
• Results posted: 2016-09-16

Locations

2 sites across 1 country: New Zealand