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Phase 2 Dose-Ranging Study of Sofosbuvir + SOC in HCV Genotype 1

NCT01054729Phase 2

Key facts

Status: Completed
Start: Jan 2010
Primary completion: Apr 2010
Countries: 2
Sponsor: Gilead Sciences
Modality: Small Molecules

Drugs: sofosbuvir
Conditions: hepatitis C (HCV)

Overview

Phase 2, randomised, double-blind trial of sofosbuvir in hepatitis C (HCV) (4 arms), sponsored by Gilead Sciences. Primary endpoint: Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period. Started Jan 2010; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

Sofosbuvir 100 mg
Sofosbuvir 100 mg + PEG + RBV for 4 weeks, then PEG + RBV
Sofosbuvir 200 mg
Sofosbuvir 200 mg + PEG + RBV for 4 weeks, then PEG + RBV
Sofosbuvir 400 mg
Sofosbuvir 400 mg + PEG + RBV for 4 weeks, then PEG + RBV
Placebo
Placebo + PEG + RBV for 4 weeks, then PEG + RBV

Who it enrols

Treatment-naïve patients with chronic HCV genotype 1 infection, aged 18-65, without HIV or Hepatitis B coinfection or other liver diseases.

Endpoints

Primary

Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment PeriodBaseline to Week 4

Secondary

Change in Circulating HCV RNA at Week 4Week 4
Percentage of Participants With Rapid Virologic Response at Week 4Week 4
Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBVPost-treatment Week 24
Plasma Pharmacokinetics of Sofosbuvir (Cmax, AUCinf, AUCtau)Day 27
Plasma Pharmacokinetics of GS-331007 (Cmax, AUCinf, AUCtau)Day 27
Plasma Pharmacokinetics of GS-566500 (Cmax, AUCinf, AUCtau)Day 27
Percentage of Participants Who Developed Resistance to SofosbuvirBaseline to Week 4

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