Genetic Polymorphisms of TNF-α Promoter and HBV Genotype on Outcome of HBV-Related Chronic Liver Disease
Primary Purpose
Chronic Liver Disease, Hepatocellular Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TNF-alpha and HBV genotype
TNF-alpha and HBV genotypes
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Liver Disease
Eligibility Criteria
Inclusion Criteria:
- HBV-positive patients
Exclusion Criteria:
- HBV-negative patients
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Outcomes
Primary Outcome Measures
cytokine gene polymorphism
Secondary Outcome Measures
cytokine gene polymorohism on severity of disease
Full Information
NCT ID
NCT00629668
First Posted
February 26, 2008
Last Updated
March 5, 2008
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00629668
Brief Title
Genetic Polymorphisms of TNF-α Promoter and HBV Genotype on Outcome of HBV-Related Chronic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The prognosis of Hepatitis B virus (HBV)infection varies from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma (HCC).Both viral and host genetic factors contribute to disease severity. Cytokine gene polymorphism has been regarded affecting prognosis of disease. By detecting HBV genotyping and tumor necrosis factor-alpha polymorphism, this study aime to assess their effects and interaction on disease severity of HBV-related chronic liver disease and HCC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease, Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
TNF-alpha and HBV genotype
Intervention Type
Other
Intervention Name(s)
TNF-alpha and HBV genotypes
Primary Outcome Measure Information:
Title
cytokine gene polymorphism
Time Frame
years
Secondary Outcome Measure Information:
Title
cytokine gene polymorohism on severity of disease
Time Frame
years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
HBV-positive patients
Exclusion Criteria:
HBV-negative patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jen-Eing Jeng, M.D.
Organizational Affiliation
Assistant Professor of Clinical Laboratory
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jen-Eing Jeng, M.D.
Phone
886-7-3121101
Ext
7223
Email
jejeng @cc.kmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Jen-Eing Jeng, M.D.
12. IPD Sharing Statement
Learn more about this trial
Genetic Polymorphisms of TNF-α Promoter and HBV Genotype on Outcome of HBV-Related Chronic Liver Disease
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