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CompletedNCT00629603Updated Apr 18, 2013

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

An interventional study of cytokine and cytokine polymorphisms in Fibrosis and Chronic Liver Disease, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 2 sites in Taiwan. Per ClinicalTrials.gov, last updated 2013-04-18.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Fibrosis
  • Chronic Liver Disease

Keywords

  • hepatitis C virus infection
  • chronic liver disease
  • fibrosis-related cytokine
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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 600 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with anti-HCV positive

Exclusion criteria

Exclusion Criteria:

  • Anti-HCV-negative patients
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Experimental
    cytokine polymorphisms, HCV infection

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

    Genetic: cytokine · Genetic: cytokine polymorphisms · Genetic: cytokine polymorphism

Interventions

  • Geneticcytokine

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

    Also known as: hepatitis C virus infection, cytokine polymorphism, fibrosis

  • Geneticcytokine polymorphisms

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

    Also known as: hepatitis C virus infection, cytokine polymorphism, fibrosis

  • Geneticcytokine polymorphism

    fibrosis-relating cytokine polymorphism

    Also known as: hepatitis C virus infection, cytoline polymorphism, fibrosis

06

What researchers measure

Primary outcomes

  1. cytokine gene polymorphism on disease severity

    Time frame: years

07

Study locations

2 sites
  • Kaohsiung Medical University Chung-Ho Hospital
    Kaohsiung, 807, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, 807, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00629603
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Jung-Fa,Tsai (1) (Professor of Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital) — Principal investigator
First posted
Mar 6, 2008
Start date
Jan 2007
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Apr 18, 2013

Study contacts

Jung-Fa Tsai, M.D., Ph.D.
principal investigator · Professor of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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