Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jung-Fa,Tsai (1), Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00629603
First received: February 26, 2008
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Fibrosis
Chronic Liver Disease
Genetic: cytokine
Genetic: cytokine polymorphisms
Genetic: cytokine polymorphism

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Polymorphisms of Fibrosis-Relating Genes on Outcome of HCV-Related Chronic Liver Disease

Resource links provided by NLM:


Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • cytokine gene polymorphism on disease severity [ Time Frame: years ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cytokine polymorphisms, HCV infection
Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease
Genetic: cytokine
polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease
Other Names:
  • hepatitis C virus infection
  • cytokine polymorphism
  • fibrosis
Genetic: cytokine polymorphisms
Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis
Other Names:
  • hepatitis C virus infection
  • cytokine polymorphism
  • fibrosis
Genetic: cytokine polymorphism
fibrosis-relating cytokine polymorphism
Other Names:
  • hepatitis C virus infection
  • cytoline polymorphism
  • fibrosis

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with anti-HCV positive

Exclusion Criteria:

  • Anti-HCV-negative patients
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00629603

Locations
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Medical University Chung-Ho Hospital
Kaohsiung, Taiwan, 807
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Principal Investigator: Jung-Fa Tsai, M.D., Ph.D. Professor of Medicine
  More Information

No publications provided

Responsible Party: Jung-Fa,Tsai (1), Professor of Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT00629603     History of Changes
Other Study ID Numbers: KMUH-IRB-950347
Study First Received: February 26, 2008
Last Updated: April 17, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
hepatitis C virus infection
chronic liver disease
fibrosis-related cytokine

Additional relevant MeSH terms:
Fibrosis
Liver Diseases
Pathologic Processes
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014