Pharmacogenomic Research in Korean Patients With Hepatitis C

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

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:

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)
SVR group
A patients who achieved SVR (sustained virologic response)
non-SVR group
A patients who not achieved SVR (sustained virologic response)


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

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
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Please refer to this study by its identifier: NCT01453244

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

Responsible Party: Jae-Gook Shin, Inje University 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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on May 23, 2016