Study for the Treatment of Significant Steatosis With Xenical Followed by Treatment of Hepatitis C With Pegasys/Copegus (HCVNASH)
|Fatty Liver Hepatitis C||Drug: Xenical, Pegasys, Copegus Behavioral: Xenicare Program||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|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|
- Sustained virological response (SVR) defined as the percentage of participants with undetectable HCV-RNA as measured by the Roche AMPLICORTM HCV Test, v 2.0 (detection limit 50 IU/mL) at 24 weeks post completion of the treatment period [ Time Frame: 110 weeks ]
- Hepatic steatosis, necroinflammatory activity and fibrosis improvement at week 36 as determined by Dr. Elizabeth Brunt at Saint Louis University [ Time Frame: 36 weeks ]
|Study Start Date:||August 2005|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: Xenical placebo
Xenical placebo PO three times daily with meals plus enrollment into the Xenicare program for 36 weeks followed by 48 weeks of therapy with Pegasys (180mcg/ml) plus weight based ribavirin for HCV genotype 1 or 4 and 24 weeks of therapy with Pegasys (180mcg/ml) plus 800mg ribavirin for HCV genotypes 2 and 3.
Behavioral: Xenicare Program
Xenicare program for 36 weeks.
Active Comparator: Xenical (orlistat)
Xenical (orlistat) 120mg PO three times daily with meals plus enrollment into the Xenicare program for 36 weeks followed by 48 weeks of therapy with Pegasys (180mcg/ml) plus weight based ribavirin for HCV genotype 1 or 4 and 24 weeks of therapy with Pegasys (180mcg/ml) plus 800mg ribavirin for HCV genotypes 2 and 3.
Drug: Xenical, Pegasys, Copegus
Xenical 120mg three times daily for 36 weeks or xenical placebo (Arm 1). Pegasys 180 mcg weekly for 48 weeks. Ribavirin daily for 48 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207311
|United States, Texas|
|Brooke Army Medical Center|
|Ft. Sam Houston, Texas, United States, 78234|
|Principal Investigator:||Stephen A Harrison, MD||Brooke Army Medical Center|