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

Tracking Information

First Received Date ^ICMJE

August 7, 2002

Last Updated Date

October 29, 2007

Start Date ^ICMJE

September 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Ishak fibrosis score [ Time Frame: 52 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00043303 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Liver Fibrosis
Cirrhosis

Intervention ^ICMJE

Drug: interferon gamma-1b

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

502

Completion Date

November 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00043303

Responsible Party

Study ID Numbers ^ICMJE

GILF-001

Study Sponsor ^ICMJE

InterMune

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Steven Porter, MD

InterMune

Information Provided By

InterMune

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP