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

NCT ID: NCT00629603

Last Updated: 2013-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-09-30

Brief Summary

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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

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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).

Conditions

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Fibrosis Chronic Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cytokine polymorphisms, HCV infection

Relate the fibrosis cytokine gene polymorphisms with disease severity of HCV-related chronic liver disease

Group Type EXPERIMENTAL

cytokine

Intervention Type GENETIC

polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease

cytokine polymorphisms

Intervention Type GENETIC

Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis

cytokine polymorphism

Intervention Type GENETIC

fibrosis-relating cytokine polymorphism

Interventions

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cytokine

polymorphisms of fibrosis-relating cytokine were measured to validate the effectiveness of fibrosis in HCV-related chronic liver disease

Intervention Type GENETIC

cytokine polymorphisms

Fibrosis-relating cytokine polymorphisms in hepatitis C virus-related chronic liver disease were measured to validate the degree of fibrosis

Intervention Type GENETIC

cytokine polymorphism

fibrosis-relating cytokine polymorphism

Intervention Type GENETIC

Other Intervention Names

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hepatitis C virus infection cytokine polymorphism fibrosis hepatitis C virus infection cytokine polymorphism fibrosis hepatitis C virus infection cytoline polymorphism fibrosis

Eligibility Criteria

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Inclusion Criteria

* Patients with anti-HCV positive

Exclusion Criteria

* Anti-HCV-negative patients
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Fa,Tsai (1)

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Fa Tsai, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine

Locations

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Kaohsiung Medical University Chung-Ho Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUH-IRB-950347

Identifier Type: -

Identifier Source: org_study_id

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