At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 75 years
- ✓HCV RNA positive by PCR
- ✓Prior treatment with at least 3 months of interferon or interferon/ribavirin, off treatment for at least 2 months before enrollment
- ✓Treatment-experienced with documented failure: non-responders (failure to clear after ≥3 months), partial responders (≥1 log reduction but detectable), breakthrough (negative on treatment then reappeared), or relapsers (negative during treatment then recurred)
- ✕Co-infection with hepatitis B or HIV
- ✕Hemochromatosis confirmed by genetic testing
- ✕Alpha-1 antitrypsin deficiency or Wilson's disease
- ✕Prior organ/liver transplantation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Brief
A Phase 4 clinical trial evaluating PEG -Intron and Colchicine for Hepatitis C Virus and 2 related conditions. Completed, enrolled 549 participants across 49 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.6mg twice a day