A Study to Evaluate the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C

A Phase II Randomized, Active-Controlled Study to Assess the Safety, Antiviral Effect, and Pharmacokinetics of Celgosivir in Combination With Peginterferon Alfa-2b and Ribavirin Over 12 Weeks in Treatment-Naïve Patients With Chronic Hepatitis C

The objective of this study is to undertake an initial evaluation of the safety, tolerability, antiviral effect, and pharmacokinetics of celgosivir in combination with peginterferon alfa-2b and ribavirin in patients with chronic HCV infection.

Inclusion Criteria:

• 18-65 years of age, inclusive
• primary diagnosis of chronic HCV infection, genotype 1
• Interferon-based treatment-naïve
• Body Mass Index of 18 to 30, inclusive

Exclusion Criteria:

• patients previously treated with Interferon-based therapy
• patients with diabetes mellitus