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

Not Applicable

Completed

• Conditions: Fibrosis; Chronic Liver Disease
• Interventions: Genetic: cytokine; Genetic: cytokine polymorphisms; Genetic: cytokine polymorphism

• Registration Number: NCT00629603
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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).

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients with anti-HCV positive

Exclusion Criteria

• Anti-HCV-negative patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cytokine polymorphisms, HCV infection	cytokine	Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease
cytokine polymorphisms, HCV infection	cytokine polymorphisms	Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease
cytokine polymorphisms, HCV infection	cytokine polymorphism	Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease

Primary Outcome Measures

Name	Time	Method
cytokine gene polymorphism on disease severity	years

Trial Locations

Locations (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Medical University Chung-Ho Hospital; 🇨🇳 Kaohsiung, Taiwan