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

Sponsor:	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

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.

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis C

Drug Information available for: Interferon gamma-1b Interferons

U.S. FDA Resources

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

No publications provided

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

Keywords provided by InterMune:

hepatitis C
liver fibrosis
liver cirrhosis

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Flaviviridae Infections
Interferon Type II
Antineoplastic Agents
Fibrosis
Interferons
Hepatitis, Viral, Human
Liver Cirrhosis

Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Pathologic Processes
Digestive System Diseases
Therapeutic Uses
Hepatitis C
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on February 08, 2010