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Sponsors and Collaborators: |
Palo Alto Institute for Research and Education, Inc Hoffmann-La Roche |
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Information provided by: | Palo Alto Institute for Research and Education, Inc |
ClinicalTrials.gov Identifier: | NCT00322179 |
The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in patients who are obese. However, it is not clear whether this is related to suboptimal dosing of the medication or alterated response in obese patients. Alterated immune response had been reported in obese patients. The goal of current study is to determine the immune response to interferon in obese compared to non-obese chronic hepatitis C in an tissue culture system.
Condition |
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Chronic Hepatitis C Obesity |
Study Type: | Observational |
Study Design: | Screening, Cross-Sectional, Defined Population, Prospective Study |
Official Title: | Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C |
Estimated Enrollment: | 20 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2006 |
To examine our hypothesis, we will incubate PBMC samples from obese and nonobese patients with IFN, followed by microarray analysis to compare the IFN response patterns in both groups of patients and to identify genes differentially regulated between these two groups. Identification of such genes will provide important insight to the mechanism of the antiviral effect of HCV. The identified genes will have the potential of serving as targets for pharmaceutical intervention aiming at enhancing the efficacy of IFN therapy for obese patients.
This is an open-label study. Ten obese and 10 nonobese patients with chronic hepatitis C will be recruited. For the purpose of this study, obese is defined as body weight >85 kg and BMI >30, and nonobese as body weight <75 kg and BMI<25.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ramsey Cheung, MD | 650-493-5000 ext 66482 | rcheung@stanford.edu |
United States, California | |
VA Palo Alto Health Care System | Recruiting |
Palo Alto, California, United States, 94304 | |
Principal Investigator: Ramsey Cheung, MD |
Principal Investigator: | Ramsey Cheung, MD | VA Palo Alto Health Care System |
Study ID Numbers: | CHR0036, PEG215 |
Study First Received: | May 4, 2006 |
Last Updated: | May 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00322179 |
Health Authority: | United States: Food and Drug Administration |
Microarray Analysis Obesity Chronic Hepatitis C |
Obesity Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Overweight Hepatitis Virus Diseases |
Body Weight Signs and Symptoms Digestive System Diseases Nutrition Disorders Overnutrition Hepatitis C Hepatitis C, Chronic |
RNA Virus Infections Flaviviridae Infections |