Assessing the Efficacy and Safety of Rosiglitazone Added to Standard Therapy for Hepatitis C Genotype 1 With Fatty Liver

Summary

To study the effectiveness and safety of adding Rosiglitazone, an insulin sensitizing agent to people with chronic hepatitis C infection genotype 1 with fatty liver disease, who are being treated with standard therapy. Standard therapy consists of weekly pegylated interferon injections and daily ribavirin pills, whose dosage is weight based. This regimen in genotype 1 patients is effective in only 45% of patients at best. In addition, this therapy must be given for 48 weeks to be effective and has alot of side-effects. One risk factor for a poor response is fatty liver. Rosiglitazone has been shown to be effective in the treatment of patients with fatty liver alone. This study hopes to show that the addition of Rosiglitazone to the standard therapy in genotype 1 patients with fatty liver disease will increase effectiveness of the standard therapy of hepatitis C.

Timeline

Start

2006-01

Primary completion

—

Completion

2007-10

Drugs

Indications