Cirrhosis Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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