Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis

This study will evaluate the safety and tolerability of IFN-g 1b in patients with advanced liver fibrosis and cirrhosis due to hepatitis C. This study will also evaluate whether IFN-g 1b is effective in reducing the amount of fibrosis in the liver.

• Men or women 18 to 75 years
• Chronic hepatitis C infection based on a history of positive anti-HCV antibody and/or HCV RNA
• History of prior treatment with interferon-a-based therapies or an assessment by the investigator that the patient would not benefit from interferon-a-based therapy or that treatment with interferon-a is contraindicated
• Stage 4, 5 or 6 liver fibrosis according to the Ishak scoring system.
• Cannot have presence of clinically evident ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding within the last 2 years (diuretic therapy of stable mild-to-moderate peripheral edema is permitted)
• Must meet minimum blood chemistry requirements
• Cannot have unstable or uncontrolled thyroid disease
• Cannot have a variety of other diseases (listed in protocol
• Other conditions for enrollment exist which would be discussed with a Clinician upon screening for the study.