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Safety and efficacy study of Interferon gamma-1b in hepatitis C patients with liver fibrosis or cirrhosis - Article


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Cirrhosis

Cirrhosis (Primary Biliary); Cirrhosis of the Liver; Liver Cirrhosis


Clinical Trial: Safety and efficacy study of Interferon gamma-1b in hepatitis C patients with liver fibrosis or cirrhosis

This study has been completed.

Sponsored by: InterMune
Information provided by: InterMune

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

MedlinePlus related topics:  Cirrhosis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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: 

Expected Total Enrollment:  500

Study start: September 2001

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   -   75 Years,  Genders Eligible for Study:  Both

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.

More Information

Study ID Numbers:  GILF-001
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  August 7, 2002
ClinicalTrials.gov Identifier:  NCT00043303
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 10, 2008



Page Updated: May 11, 2006
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