NCT00629603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

2.7 years

First QC Date

February 26, 2008

Last Update Submit

April 17, 2013

Conditions

FibrosisChronic Liver Disease

Keywords

hepatitis C virus infectionchronic liver diseasefibrosis-related cytokine

Outcome Measures

Primary Outcomes (1)

  • cytokine gene polymorphism on disease severity

    years

Study Arms (1)

cytokine polymorphisms, HCV infection

EXPERIMENTAL

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

Genetic: cytokineGenetic: cytokine polymorphismsGenetic: cytokine polymorphism

Interventions

cytokineGENETIC

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
cytokine polymorphisms, HCV infection
cytokine polymorphismsGENETIC

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
cytokine polymorphisms, HCV infection
cytokine polymorphismGENETIC

fibrosis-relating cytokine polymorphism

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with anti-HCV positive

You may not qualify if:

  • Anti-HCV-negative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaohsiung Medical University Chung-Ho Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

Location

MeSH Terms

Conditions

FibrosisHepatitis C

Interventions

Cytokines

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Intercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Jung-Fa Tsai, M.D., Ph.D.

    Professor of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

January 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

TW(2)