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

Sponsored by:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00043303

Purpose

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.

Condition	Intervention	Phase
Liver Fibrosis Cirrhosis	Drug: interferon gamma-1b	Phase II

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis C

Drug Information available for: Interferons Interferon gamma-1b

U.S. FDA Resources

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

Further study details as provided by InterMune:

Primary Outcome Measures:

Ishak fibrosis score [ Time Frame: 52 weeks ]

Enrollment:	502
Study Start Date:	September 2001
Study Completion Date:	November 2003

Intervention Details:

100 or 200 mcg, SQ, 3x per week

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043303

Sponsors and Collaborators

InterMune

Investigators

Study Director:

Steven Porter, MD

InterMune

More Information

Study ID Numbers:	GILF-001
Study First Received:	August 7, 2002
Last Updated:	October 29, 2007
ClinicalTrials.gov Identifier:	NCT00043303
Health Authority:	United States: Food and Drug Administration

Keywords provided by InterMune:

hepatitis C
liver fibrosis
liver cirrhosis

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Hepatic fibrosis
Digestive System Diseases
Interferon Type II

Fibrosis
Interferons
Hepatitis, Viral, Human
Liver Cirrhosis
Hepatitis C
Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Pathologic Processes
Flaviviridae Infections

Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009