Trials / Completed
CompletedNCT00043303
Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
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.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 502 (actual)
- Sponsor
- InterMune · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | interferon gamma-1b | 100 or 200 mcg, SQ, 3x per week |
Timeline
- Start date
- 2001-09-01
- Completion
- 2003-11-01
- First posted
- 2002-08-09
- Last updated
- 2007-11-01
Source: ClinicalTrials.gov record NCT00043303. Inclusion in this directory is not an endorsement.