Microarray Analysis of IFN-Induced Gene Expression in Obe... | NCT00322179

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

NCT00322179

Sponsor

Palo Alto Veterans Institute for Research

Status

Completed

Last Update Posted

Mar 4, 2020Actual

Enrollment

22Actual

Phase

Not provided

Conditions

Chronic Hepatitis C
Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PEG215

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2008Actual

First Submitted Date

May 4, 2006

First Submission Date that Met QC Criteria

May 4, 2006

First Posted Date

May 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2020

Last Update Posted Date

Mar 4, 2020Actual

Name	Class
Hoffmann-La Roche	INDUSTRY

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ramsey Cheung, MD	VA Palo Alto Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Palo Alto Health Care System		Palo Alto	California	94304	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12939590	Background	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.
7904252	Background	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.

ID	Term
D019698	Hepatitis C, Chronic
D009765	Obesity

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Label	Type	Description	Intervention Names
Obese
Non-Obese