Study of Long-Term Peg Intron Vs. Colchicine in Non-Responders.
Recruitment status was Active, not recruiting
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 Interferon/Rebetron/Peg 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.
Hepatitis C Virus
Drug: PEG interferon Alfa-2b; Colchicine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase IV Study of Long Term Peg-Intron for Patients Who Have Failed to Respond to Rebetron/Interferon With Advanced Fibrosis and Cirrhosis Secondary to Hepatitis C- The Copilot Trial|
- Determination of the effect of PEG-Intron 0.5mg per kg weekly sc versus colchicine 0.6mg bid daily on:
- 4 year survival or hepatic transplantation
- Variceal or portal hypertensive bleeding
- Development of jaundice, ascites or encephalopathy with an increase in CPT of > 2 points
- Development of hepatoma
- Evaluation of safety and tolerability of long term maintenance PEG-Intron in patients with cirrhosis
- Evaluation of the effect of long term maintenance PEG-Intron on quality of life
- Evaluation of surrogate markers of fibrosis in determining effect of long term maintenance PEG-Intron on prevention of progression of fibrosis and correlation of fibrosis markers with pathology.
- Development of portal hypertension
- Progression of histological fibrosis
|Study Start Date:||January 2001|
|Estimated Study Completion Date:||December 2009|
We are proposing a randomized trial of Peg-Intron 0.5mcg per kg weekly versus colchicine 0.6mg bid in prior non-responders to Interferon, Rebetron, PegIntron, or PegIntron & Ribavirin or any third agent such as Pegasys, CellCept, Amantadine with advanced fibrosis/cirrhosis. 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.
Show 49 Study Locations
|Principal Investigator:||Nezam H Afdhal, MD||Beth Israel Deaconess Medical Center|