Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
The purpose of this research study is to test the safety and effectiveness of Interferon
 gamma-1b (IFN-g 1b) injected subcutaneously (under the skin) for the treatment of advanced
 liver fibrosis and cirrhosis in patients with chronic hepatitis C infections.

 IFN-g 1b is not currently approved for the treatment of liver fibrosis.
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.