NCT00630006

Brief Summary

The prognosis of chronic hepatitis C virus (HCV)infeciton varies from minimal progressive disease to cirrhosis or hepatocellular carcinoma. Host genetic factors contribute to disease severity. It is known that cytokine gene (including tumor necrosis factor-alpha (TNF-alpha) and interleukin-10 (IL-10) polymorphism affect disease prognosis.This study aims to assess the effect of TNF-alpha and IL-10, and their interaction,on prognosis of HCV-related chronic liver disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

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
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 6, 2008

Status Verified

July 1, 2007

First QC Date

February 26, 2008

Last Update Submit

March 5, 2008

Conditions

Hepatitis C Virus InfectionChronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • cytokine gene polymorphism

    years

Secondary Outcomes (1)

  • cytokine gene polymorphism on severity of disease

    years

Interventions

TNF-alpha and IL-10GENETIC

Eligibility Criteria

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

You may qualify if:

  • Anti-HCV-positive patients

You may not qualify if:

  • Anti-HCV-negative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Tumor Necrosis Factor-alphaInterleukin-10

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesMonokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTumor Necrosis FactorsBlood ProteinsProteinsBiological FactorsInterleukins

Study Officials

  • Jen-Eing Jeng, M.D.

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jen-Eing Jeng, M.D.

CONTACT

886-7-3121101jejeng@cc.kmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 6, 2008

Study Start

January 1, 2007

Study Completion

December 1, 2008

Last Updated

March 6, 2008

Record last verified: 2007-07

Locations

TW(3)