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

March 2, 2020 updated by: Ramsey Cheung, Palo Alto Veterans Institute for Research

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Palo Alto, California, United States, 94304
    - VA Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Other

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Obese
Non-Obese

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

Hoffmann-La Roche

Investigators

Principal Investigator: Ramsey Cheung, MD, VA Palo Alto Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria