Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179413
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2005-09-10
Brief Title:
Study of Long-term Peg Intron vs Colchicine in Non-responders
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Phase IV Study of Long Term Peg-Intron for Patients Who Have Failed to Respond to RebetronInterferon With Advanced Fibrosis and Cirrhosis Secondary to Hepatitis C- The Copilot Trial
Status:
COMPLETED
Status Verified Date:
2017-06
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:
COPILOT
Brief Summary:
In this study Peg-Intron will be tested to see if it will give better results than Colchicine At this time there is currently no recommended maintenance treatment for patients who have failed to respond to InterferonRebetronPeg Intron and have advanced fibrosis The purpose of this study is to compare two treatments to slow down the progression of liver disease and to prevent liver failure and liver cancer The treatment will not cure Hepatitis C but is being evaluated to see if it can slow down disease progression
Detailed Description:
We are proposing a randomized trial of Peg-Intron 05mcg per kg weekly versus colchicine 06mg bid in prior non-responders to Interferon Rebetron PegIntron or PegIntron Ribavirin or any third agent such as Pegasys CellCept Amantadine with advanced fibrosiscirrhosis The specific aims of this proposal are to evaluate the role of long term Peg-Intron therapy on the natural history of patients with advanced chronic HCV infection with a primary focus on prevention of hepatic decompensation progression of fibrosis and hepatoma development
The study design will focus on 3 monthly clinical evaluation for decompensation of liver function rigorous clinical screening for development of hepatocellular cancer and liver biopsies for determination of progression of liver fibrosis every second year
The study design will focus on 3 monthly clinical evaluation for decompensation of liver function rigorous clinical screening for development of hepatocellular cancer and liver biopsies for determination of progression of liver fibrosis every second year
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