Hepatitis C Clinical Trial
Official title:
A Multi-Centered, Prospective, Randomized, Placebo-Controlled Clinical Trial for the Treatment of Significant Steatosis or NASH With Xenical Followed by Treatment of Hepatitis C (HCV) With PEG-Interferon Alpha-2a/Copegus
This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with histological evidence of > 33% hepatic steatosis or nonalcoholic steatohepatitis (NASH) and chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment naive) will be enrolled.
Recent evidence suggests that patients with concomitant chronic HCV infection and NASH or
significant hepatic steatosis (>33%) respond less well to standard antiviral therapy. As
previously noted, up to 10% of patients with chronic HCV infection will have concomitant
NASH and an even greater percentage will have associated hepatic steatosis. No prospective
studies to date have evaluated the sustained viral response rates to standard antiviral
therapy in this group of patients who were previously treated with a medication to eliminate
or improve the underlying NASH and/or hepatic steatosis.
Primary Outcome: To determine if decreasing the amount of NASH or hepatic steatosis in
overweight (BMI >27 kg/m2) HCV patients results in improved overall SVR to PEGASYS and
Copegus.
Secondary Outcome: 1.To determine the amount of steatosis, necroinflammatory activity, and
fibrosis change in a group of participants with chronic hepatitis C and NASH or significant
steatosis treated with Xenical vs. placebo for 36 weeks. 2. To assess for a difference in
insulin resistance, as measured by the QUICKI score, before and after treatment with Xenical
or Xenical placebo and diet and exercise.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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