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

InterMune

Status and phase

Completed

Phase 2

Conditions

Cirrhosis

Liver Fibrosis

Treatments

Drug: interferon gamma-1b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00043303

GILF-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

502 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.