Efficacy and Safety Study of GS-9450 Treatment for 6 Months in Patients With Chronic Hepatitis C Virus Infection
Status:
Terminated
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled, multicenter
study investigating the safety, tolerability and efficacy of two oral doses of GS-9450 in
adults with chronic Hepatitis C Virus (HCV). Approximately 240 subjects 18-65 years of age
who meet study entry criteria will be randomized (in other words, selected at random, like
flipping a coin) to one of three treatment groups (80 subjects per treatment group) as
follows:GS-9450 10 mg once daily,GS-9450 40 mg once daily, or matching placebo once daily.
Following randomization, subjects will return within seven business days for a Baseline (Day
1) visit, at which time study medication will be dispensed and subjects will enter a 26 week
treatment phase. During the treatment phase, subjects will receive study drug once daily for
24 weeks and then taper off of study drug over the following 2 weeks by receiving study drug
once every other day for one week and then every 3 days for one week. Following completion of
the treatment phase, subjects will enter a 4-week off-treatment follow-up phase.