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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
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Ramsey Cheung, Palo Alto Veterans Institute for Research

Tracking Information
First Submitted Date May 4, 2006
First Posted Date May 5, 2006
Last Update Posted Date March 4, 2020
Study Start Date November 2005
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C
Official Title Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
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
Condition
  • Chronic Hepatitis C
  • Obesity
Intervention Not Provided
Study Groups/Cohorts
  • Obese
  • Non-Obese
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 6, 2009)
22
Original Enrollment
 (submitted: May 4, 2006)
20
Actual Study Completion Date November 2008
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00322179
Other Study ID Numbers CHR0036ARG
PEG215
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ramsey Cheung, Palo Alto Veterans Institute for Research
Study Sponsor Palo Alto Veterans Institute for Research
Collaborators Hoffmann-La Roche
Investigators
Principal Investigator: Ramsey Cheung, MD VA Palo Alto Health Care System
PRS Account Palo Alto Veterans Institute for Research
Verification Date March 2020