HCV Infection Clinical Trial
Official title:
A Phase 2b, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of GS 9450 in Adults With Chronic Hepatitis C Virus Infection (GS-US-227-0106)
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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