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

Condition(s) targeted: Liver Fibrosis; Cirrhosis

Intervention: interferon gamma-1b (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: InterMune

Official(s) and/or principal investigator(s):
Steven Porter, MD, Study Director, Affiliation: InterMune

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.

Official title: A Multicenter Study of the Safety and Anti-Fibrotic Efficacy of Interferon-Gamma 1b (Actimmune) in Patients With Severe Lever Fibrosis or Compensated Cirrhosis Due to Hepatitis C.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Ishak fibrosis score

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Starting date: September 2001
Ending date: November 2003
Last updated: October 29, 2007