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.
|
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.
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
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

Not Signed In -


