BMS-790052 with Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects with Chronic Hepatitis C Genotype 1
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Investigator: Mandana Khalili, MD
Sponsor: Bristol-Myers Squibb Company
Location(s): Egypt; Sweden; Mexico; Puerto Rico; Canada; Australia
Description
At least 1 dose of BMS-790052 combined with Standard of Care (pegylated interferon and ribavirin) can be identified which is safe, well tolerated, and demonstrates extended rapid virologic response rates at least 35% greater than placebo.
Primary Outcome Measures
- Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with extended rapid virologic response, defined as undetectable HCV RNA
- Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response, defined as undetectable HCV RNA
- Safety, as measured by the frequency of Serious Adverse Events and discontinuations due to Adverse Events
Secondary Outcome Measures
- To assess the proportion of HCV genotype 1 subjects with rapid virologic response, ie, undetectable HCV RNA
- To assess the proportion of HCV genotype 1 subjects with complete early virologic response, ie, undetectable HCV RNA
- To assess the proportion of HCV genotype 1 subjects with 12-week sustained virologic response, ie, undetectable HCV RNA
- To describe resistant variants associated with virologic failure
Enrollment: 395