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

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C Obesity

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

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

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:

Bressler BL, Guindi M, Tomlinson G, Heathcote J. High body mass index is an independent risk factor for nonresponse to antiviral treatment in chronic hepatitis C. Hepatology. 2003 Sep;38(3):639-44.

Camps J, Crisostomo S, Garcia-Granero M, Riezu-Boj JI, Civeira MP, Prieto J. Prediction of the response of chronic hepatitis C to interferon alfa: a statistical analysis of pretreatment variables. Gut. 1993 Dec;34(12):1714-7.

Farooqi IS, Matarese G, Lord GM, Keogh JM, Lawrence E, Agwu C, Sanna V, Jebb SA, Perna F, Fontana S, Lechler RI, DePaoli AM, O'Rahilly S. Beneficial effects of leptin on obesity, T cell hyporesponsiveness, and neuroendocrine/metabolic dysfunction of human congenital leptin deficiency. J Clin Invest. 2002 Oct;110(8):1093-103.

Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82.

Ji X, Cheung R, Cooper S, Li Q, Greenberg HB, He XS. Interferon alfa regulated gene expression in patients initiating interferon treatment for chronic hepatitis C. Hepatology. 2003 Mar;37(3):610-21. Erratum in: Hepatology. 2003 Jun;37(6):1503.

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, Chronic
Hepatitis C
Obesity
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases

Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013