Pharmacogenomic Research in Korean Patients With Hepatitis C

Sponsor
Inje University (Other)
Overall Status
Completed
CT.gov ID
NCT01453244
Collaborator
(none)
373
1
20
18.6

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    373 participants
    Observational Model:
    Cohort
    Official Title:
    Pharmacogenomic Research for Prediction of Drug Response in Korean Patients With Hepatitis C
    Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Mar 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    SVR group

    A patients who achieved SVR (sustained virologic response)

    non-SVR group

    A patients who not achieved SVR (sustained virologic response)

    Outcome Measures

    Primary Outcome Measures

    1. Sustained virological response (SVR) [24 weeks after the end of treatment]

      Undetectable HCV RNA in serum ( <15 IU/ml ) 24 weeks after the end of treatment

    Secondary Outcome Measures

    1. Anemia [4 weeks after start of treatment]

      a reduction in Hemoglobin of >3.0 g/dL a reduction in Hemoglobin levels to 10.0g/dL.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Hepatitis C virus infected patients
    Exclusion Criteria:
    • Patients who infected Hepatitis B virus or Human immunodeficiency virus

    • HCV infected patients previously treated with antiviral drugs

    • Patients had a history of autoimmune hemolytic anemia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inje University Busan Korea, Republic of 633-165

    Sponsors and Collaborators

    • Inje University

    Investigators

    • Principal Investigator: Jae-Gook Shin, M.D, phD, Inje University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jae-Gook Shin, Jae-Gook Shin, Inje University
    ClinicalTrials.gov Identifier:
    NCT01453244
    Other Study ID Numbers:
    • 11-037
    First Posted:
    Oct 17, 2011
    Last Update Posted:
    Jun 3, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by Jae-Gook Shin, Jae-Gook Shin, Inje University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 3, 2013