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

Cirrhosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043303
• Other study ID #: GILF-001
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2002
• Last updated: October 29, 2007
• Start date: September 2001
• Est. completion date: November 2003

Study information

• Verified date: October 2007
• Source: InterMune
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hepatitis C
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Drug:
• interferon gamma-1b
100 or 200 mcg, SQ, 3x per week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
InterMune

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ishak fibrosis score		52 weeks