HCV Infection Clinical Trial
Official title:
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV)
fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and
tolerability of each regimen as assessed by review of the accumulated safety data.
Approximately 150 participants with genotype 1 HCV infection, who have previously received
treatment for HCV, and who have a diagnosis for cirrhosis will be enrolled. Participants will
be randomized to 1 of 2 groups.
Group 1: SOF/LDV FDC tablet plus placebo to match RBV for 24 weeks
Group 2: Delayed treatment group: placebo to match SOF/LDV FDC plus placebo to match RBV for
12 weeks, followed by SOF/LDV FDC once daily plus RBV in a divided daily dose for 12 weeks
Randomization will 1:1 to the two groups and will be stratified by HCV genotype (1a, 1b;
mixed or other genotype 1 results will be stratified as genotype 1a), and prior HCV therapy
treatment response (never achieved HCV RNA < the lower limit of quantitation (LLOQ), or
achieved HCV RNA < LLOQ).
n/a
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