Conditions: Hepatitis C Virus Advanced Fibrosis Cirrhosis
Keywords: hepatitis C cirrhosis interferon colchicine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 549
Healthy volunteers: no

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 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.

Detailed description:
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.

Arms:
arm 1: PEG-Intron 0.5mcg/kg once a week SC arm 2: 0.6mg twice a day

Interventions: intervention 1: PEG -Intron intervention 2: Colchicine
Intervention descriptions: intervention 1: None intervention 2: 0.6mg twice a day

Protocol document: