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



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

For Condition: Liver Fibrosis,Cirrhosis
Status: Completed
Sponsor(s): InterMune ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 500

Location and Contact Information:


Additional Information:
Study ID Numbers:
  GILF-001; 
Study Start Date: September 2001
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043303

Other Liver Fibrosis Studies:
1. PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to alpha-Interferon Plus Ribavirin

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

3. Prevention of Disease Progress in Chronic HepC Pts Significant Liver Fibrosis who failed PEG-Intron + Rebetol in P02370

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