Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

Completed

• Conditions: Chronic Hepatitis C; Obesity

• Registration Number: NCT00322179
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-05-04
• Study First Submitted QC: 2006-05-04
• Study First Posted: 2006-05-05
• Primary Completion: 2007-11
• Study Completion: 2008-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• obese (weight > 85kg and BMI>30) or non-obese patients (<75kg and BMI <25) with chronic Hepatitis C
• Chronic Hepatitis C infection with documented HCV RNA
• Body habitat either as obese or non-obese as defined above
• Currently not under IFN therapy
• Non-African American

Exclusion Criteria

• Body habitat neither obese or non-obese as defined for the purpose of this study
• Unable to give consent
• On immunomodulatory agents such as prednisone
• Active infection other than Hepatitis C
• Co-infection with HBV or HIV
• Active or excessive alcohol use
• Other cause of chronic Hepatitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States