Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00043303|
Recruitment Status : Completed
First Posted : August 9, 2002
Last Update Posted : November 1, 2007
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 or disease||Intervention/treatment||Phase|
|Liver Fibrosis Cirrhosis||Drug: interferon gamma-1b||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||502 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||September 2001|
|Actual Study Completion Date :||November 2003|
- Drug: interferon gamma-1b
100 or 200 mcg, SQ, 3x per week
- Ishak fibrosis score [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043303
|Study Director:||Steven Porter, MD||InterMune|