Genetic Polymorphisms of Interleukin-10 and TNF-α on Outc... | NCT00630006

Studies
Genetic Polymorphisms of Interleukin-10 and TNF-α on Outcome of HCV-Related Chronic Liver Disease

NCT00630006

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Unknown status

Last Update Posted

Mar 6, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Hepatitis C Virus Infection
Chronic Liver Disease

Interventions

TNF-alpha and IL-10

Countries

Taiwan

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

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Mar 5, 2008

First Posted Date

Mar 6, 2008Estimated

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 5, 2008

Last Update Posted Date

Mar 6, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The prognosis of chronic hepatitis C virus (HCV)infeciton varies from minimal progressive disease to cirrhosis or hepatocellular carcinoma. Host genetic factors contribute to disease severity. It is known that cytokine gene (including tumor necrosis factor-alpha (TNF-alpha) and interleukin-10 (IL-10) polymorphism affect disease prognosis.This study aims to assess the effect of TNF-alpha and IL-10, and their interaction,on prognosis of HCV-related chronic liver disease

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
TNF-alpha and IL-10	Genetic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cytokine gene polymorphism		years

Secondary Outcomes

Measure	Description	Time Frame
cytokine gene polymorphism on severity of disease		years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anti-HCV-positive patients

Exclusion Criteria:

Anti-HCV-negative patients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jen-Eing Jeng, M.D.	Contact	886-7-3121101	7223	jejeng@cc.kmu.edu.tw

Overall Officials

Name	Affiliation	Role
Jen-Eing Jeng, M.D.	Assistant Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Medical University Chung-Ho Memorial Hospital	Recruiting	Kaohsiung City	Kaohsiung	807	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014409	Tumor Necrosis Factor-alpha
D016753	Interleukin-10

Ancestor Terms

ID	Term
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D015846	Monokines

Browse Leaves

Not provided

Browse Branches

Not provided