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

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ClinicalTrials.gov Identifier: NCT00322179

Recruitment Status : Completed

First Posted : May 5, 2006

Last Update Posted : March 4, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by (Responsible Party):

Ramsey Cheung, Palo Alto Veterans Institute for Research

Study Description

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.

Condition or disease
Chronic Hepatitis C Obesity

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 Design

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Study Type :	Observational
Actual Enrollment :	22 participants
Observational Model:	Other
Time Perspective:	Other
Official Title:	Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C
Study Start Date :	November 2005
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genes and Gene Therapy Hepatitis Hepatitis A Hepatitis C

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Obese
Non-Obese

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322179

Locations

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

Sponsors and Collaborators

Palo Alto Veterans Institute for Research

Hoffmann-La Roche

Investigators

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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. doi: 10.1053/jhep.2003.50350.

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. doi: 10.1136/gut.34.12.1714.

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. doi: 10.1172/JCI15693.

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. doi: 10.1056/NEJMoa020047.

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. doi: 10.1053/jhep.2003.50105. Erratum In: Hepatology. 2003 Jun;37(6):1503.

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Responsible Party:	Ramsey Cheung, Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier:	NCT00322179
Other Study ID Numbers:	CHR0036ARG PEG215
First Posted:	May 5, 2006 Key Record Dates
Last Update Posted:	March 4, 2020
Last Verified:	March 2020

Keywords provided by Ramsey Cheung, Palo Alto Veterans Institute for Research:


Microarray Analysis Obesity Chronic Hepatitis C

Additional relevant MeSH terms:

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Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human	Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections

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