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

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00043303
First received: August 7, 2002
Last updated: October 29, 2007
Last verified: October 2007
History of Changes
  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 2

Study Type: Interventional
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
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:

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:
    Drug: interferon gamma-1b
    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

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

Keywords provided by InterMune:
hepatitis C
liver fibrosis
liver cirrhosis

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-gamma
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013