Trials / Completed
CompletedNCT00179413
Study of Long-term Peg Intron vs. Colchicine in Non-responders.
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 549 (actual)
- Sponsor
- Beth Israel Deaconess Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEG -Intron | |
| DRUG | Colchicine | 0.6mg twice a day |
Timeline
- Start date
- 2000-01-15
- Primary completion
- 2009-12-31
- Completion
- 2010-03-03
- First posted
- 2005-09-16
- Last updated
- 2017-07-11
- Results posted
- 2017-07-11
Locations
49 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00179413. Inclusion in this directory is not an endorsement.