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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier:
NCT00322179
First received: May 4, 2006
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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
Chronic Hepatitis C
Obesity

Study Type: Observational
Official Title: Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Palo Alto Institute for Research and Education, Inc:

Enrollment: 22
Study Start Date: November 2005
Study Completion Date: November 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00322179

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Palo Alto Institute for Research and Education, Inc
Hoffmann-La Roche
Investigators
Principal Investigator: Ramsey Cheung, MD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: Stephen J. Rossi, PharmD, Roche Laboratories
ClinicalTrials.gov Identifier: NCT00322179     History of Changes
Other Study ID Numbers: CHR0036, PEG215
Study First Received: May 4, 2006
Last Updated: April 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Palo Alto Institute for Research and Education, Inc:
Microarray Analysis
Obesity
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Obesity
Body Weight
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Nutrition Disorders
Overnutrition
Overweight
Picornaviridae Infections
RNA Virus Infections
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014