Cirrhosis, Liver Fibrosis
Conditions
Keywords
hepatitis C, liver fibrosis, liver cirrhosis
Brief 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.
Detailed description
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.
Interventions
100 or 200 mcg, SQ, 3x per week
Sponsors
Study design
Eligibility
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ishak fibrosis score | 52 weeks |