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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00629486
Other study ID # KMUH-IRB-950181
Secondary ID
Status Completed
Phase N/A
First received February 26, 2008
Last updated April 17, 2013
Start date January 2007
Est. completion date May 2008

Study information

Verified date April 2013
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.


Description:

Hepatitis B virus (HBV)infection is the major risk factor for chronic liver disease and hepatocellular carcinoma (HCC). Host immunogenetic factors contribute to HBV-associated liver damage and/or carcinogenesis. Variant cytokine alleles, including tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β), might contribute to interindividual difference in inflammatory responses and account for heterogeneous disease outcome of infectious disease.

By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- HBsAg-positive patients

Exclusion Criteria:

- HBsAg-negative patients

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Genetic:
Polymorphism of IL-1 beta and TNF-alpha
To analyze the role of polymorphisms of IL-1beta and TNF-alpha gene on risk of hepatitis B-related chronic liver disease and hepatocellular carcinoma

Locations

Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Hospital Kaohsiung
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary cytokine polymorphisms increase risk for hepatocellular carcinoma years No
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