Hepatitis c Clinical Trial
Official title:
48 Week Pilot Trial Assessing the Efficacy of Pioglitazone, Atorvastatin, Pegasys and Weight Based Ribavirin in Chronic Hepatitis C, Genotype 1 Patients Who Have Previously Relapsed or Did Not Respond to PegInterferon /Ribavirin Therapy
The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.
The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of
insulin resistance and lipid levels prior to the addition of pegylated interferon and
ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance
patients may then be in a position to respond more favorably to current antiviral therapy
consisting of pegylated interferon and ribavirin.
This study could demonstrate the value of pretreating and continuing treatment for insulin
resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded
or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not
a primary or secondary endpoint in this study.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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