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

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Medical Center
• Treatments: Peginterferon alfa-2a; Ribavirin; Rosiglitazone

Criteria

Inclusion Criteria:

• Men and women at least 21 years of age.

• Positive serum hepatitis C RNA for at least 6 months.

• Naive to any therapy for hepatitis C infection.

• Significant steatosis or fat on the liver biopsy.

• Genotype 1 patients.

Exclusion Criteria:

• Subjects with decompensated liver disease.

• Hemoglobin <12g/dl.

• WBC<2,000mm3.

• ANC<1,000mm3.

• Platelet count<50,000/mm3.

• Creatinine>1.5mg/dl.

• Albumin<2.5g/dl.

• Bilirubin>4mg/dl.

• HIV or hepatitis B co-infection.

• History of other liver disease besides fatty liver disease.

• History of unstable cardiac or cerebrovascular disease.

• History of significant psychiatric disorders.

• Alcohol or drug abuse within last year.

• Pregnant or lactating women or men whose sexual partner is pregnant or lactating.

• Taking of insulin or oral hypoglycemic agents within six months of the study.

• Uncontrolled thyroid disorder.

• History of malignancy within the past 5 years unless cured by surgery.

• History of autoimmune disorder or organ transplantations requiring immunosuppression.