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

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InterMune
• Treatments: Interferon-gamma; Interferons

Criteria

• 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.