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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 C
Liver Cirrhosis
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Pathologic Processes
RNA Virus Infections
Virus Diseases
Interferon-gamma
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014