Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043303
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2002-08-07
Brief Title:
Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
Sponsor:
InterMune
Organization:
InterMune
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None