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Sponsors and Collaborators: |
The Geneva Foundation Hoffmann-La Roche |
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Information provided by: | Brooke Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00207311 |
This is a prospective, multi-center, randomized, placebo-controlled trial in subjects with histological evidence of >33% hepatic steatosis or NASH and chronic hepatitis C. Patients who have not been previously treated for hepatitis C (treatment naïve) will be enrolled
Condition | Intervention | Phase |
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Fatty Liver Hepatitis C |
Drug: Xenical vs Placebo, behavior modification, Pegasys, Copegus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 280 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | August 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hemoglobin values of <12 gm/dL for females and <13 gm/dL for males, WBC <3,000/ mm3,Neutrophil count < 1,500/mm3,Platelets <65,000/ mm3,Direct bilirubin within 20% of ULN,Indirect bilirubin(WNL, Albumin >3gm/dL, creatinine < 20% of ULN, TSH WNL,Alpha fetoprotein value < 100 ng/mL
Exclusion Criteria:
Contact: Stephen A Harrison, MD | 210-916-5553 | |
Contact: Karol Barstow, BSN RN CCRC | 210-916-5553 | karol.barstow@amedd.army.mil |
United States, Texas | |
Brooke Army Medical Center | Recruiting |
Ft. Sam Houston, Texas, United States, 78234 | |
Contact: Stephen A Harrison, MD 210-916-5553 | |
Contact: Karol Barstow, RN BSN CCRC 210-916-5553 karol.barstow@amedd.army.mil | |
Principal Investigator: Stephen A Harrison, MD | |
Sub-Investigator: Christopher Fincke, MD |
Principal Investigator: | Stephen A Harrison, MD | Brooke Army Medical Center |
Study ID Numbers: | C.2004.140 |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00207311 |
Health Authority: | United States: Federal Government |
Hepatitis C Fatty Liver NASH Steatohepatitis |
Interferon-alpha Liver Diseases Ribavirin Interferons Hepatitis, Viral, Human Fatty Liver Hepatitis |
Virus Diseases Orlistat Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a |
Anti-Infective Agents Anti-Obesity Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections |
Therapeutic Uses Enzyme Inhibitors Antiviral Agents Central Nervous System Agents Pharmacologic Actions |