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

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ClinicalTrials.gov Identifier: NCT00043303
Recruitment Status : Completed
First Posted : August 9, 2002
Last Update Posted : November 1, 2007
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Liver Fibrosis Cirrhosis Drug: interferon gamma-1b Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2001
Study Completion Date : November 2003

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

Primary Outcome Measures :
  1. Ishak fibrosis score [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043303

Sponsors and Collaborators
Study Director: Steven Porter, MD InterMune

ClinicalTrials.gov Identifier: NCT00043303     History of Changes
Other Study ID Numbers: GILF-001
First Posted: August 9, 2002    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by InterMune:
hepatitis C
liver fibrosis
liver cirrhosis

Additional relevant MeSH terms:
Hepatitis C
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Pathologic Processes
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents