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Pharmacogenomic Research in Korean Patients With Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01453244
First received: October 13, 2011
Last updated: May 30, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Chronic Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Pharmacogenomic Research for Prediction of Drug Response in Korean Patients With Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inje University:

Primary Outcome Measures:
  • Sustained virological response (SVR) [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
    Undetectable HCV RNA in serum ( <15 IU/ml ) 24 weeks after the end of treatment


Secondary Outcome Measures:
  • Anemia [ Time Frame: 4 weeks after start of treatment ] [ Designated as safety issue: Yes ]
    1. a reduction in Hemoglobin of >3.0 g/dL
    2. a reduction in Hemoglobin levels to 10.0g/dL.


Biospecimen Retention:   Samples With DNA

DNA extracted from blood


Enrollment: 373
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
SVR group
A patients who achieved SVR (sustained virologic response)
non-SVR group
A patients who not achieved SVR (sustained virologic response)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Korean patients with chronic hepatitis C

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453244

Locations
Korea, Republic of
Inje University
Busan, Korea, Republic of, 633-165
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Jae-Gook Shin, M.D, phD Inje University
  More Information

No publications provided

Responsible Party: Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier: NCT01453244     History of Changes
Other Study ID Numbers: 11-037
Study First Received: October 13, 2011
Last Updated: May 30, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:
Chronic hepatitis C
Pharmacogenomics
IL28B
ITPA

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on June 18, 2013