Back to resultsPolymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
Primary Purpose
Fibrosis, Chronic Liver Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cytokine
cytokine polymorphisms
cytokine polymorphism
Sponsored by
About this trial
This is an interventional basic science trial for Fibrosis focused on measuring hepatitis C virus infection, chronic liver disease, fibrosis-related cytokine
Eligibility Criteria
Inclusion Criteria:
- Patients with anti-HCV positive
Exclusion Criteria:
- Anti-HCV-negative patients
Sites / Locations
- Kaohsiung Medical University Chung-Ho Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cytokine polymorphisms, HCV infection
Arm Description
Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease
Outcomes
Primary Outcome Measures
cytokine gene polymorphism on disease severity
Secondary Outcome Measures
Full Information
NCT ID
NCT00629603
First Posted
February 26, 2008
Last Updated
April 17, 2013
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00629603
Brief Title
Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
Official Title
Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hepatitis C virus (HCV) infection causes different disease spectrum ranging from minimal progressive liver disease to cirrhosis or hepatocellular carcinoma. Evidence indicates that host genetic factor may play a role in determining disease progression. It is known that many cytokine polymorphisms affect disease progressin via increasing hepatic fibrosis that are key factors in progressing liver injury. By combinations of fibrosis-relating gene polymorphisms, this study aims to identify patients with high risk for progressive liver disease. These patients need intensive therapy to decrease morbidity and mortality of chronic HCV-related liver disease.
Detailed Description
Determination of the following fibrosis-relating gene polymorphisms in HCV-related chronic liver disease and HCC will be performed: TNF-α , TNF-β, Factor V Leiden, TGF-β1, PDGF-B gene, Angiotensinogen (AT),Angiotensin converting enzyme (ACE), microsomal epoxide hydrolase (mEH) and glutathione-S-transferase (GST).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis, Chronic Liver Disease
Keywords
hepatitis C virus infection, chronic liver disease, fibrosis-related cytokine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cytokine polymorphisms, HCV infection
Arm Type
Experimental
Arm Description
Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease
Intervention Type
Genetic
Intervention Name(s)
cytokine
Other Intervention Name(s)
hepatitis C virus infection, cytokine polymorphism, fibrosis
Intervention Description
polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease
Intervention Type
Genetic
Intervention Name(s)
cytokine polymorphisms
Other Intervention Name(s)
hepatitis C virus infection, cytokine polymorphism, fibrosis
Intervention Description
Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis
Intervention Type
Genetic
Intervention Name(s)
cytokine polymorphism
Other Intervention Name(s)
hepatitis C virus infection, cytoline polymorphism, fibrosis
Intervention Description
fibrosis-relating cytokine polymorphism
Primary Outcome Measure Information:
Title
cytokine gene polymorphism on disease severity
Time Frame
years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with anti-HCV positive
Exclusion Criteria:
Anti-HCV-negative patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Fa Tsai, M.D., Ph.D.
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease
We'll reach out to this number within 24 hrs