Pharmacogenomic Research in Korean Patients With Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01453244
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : June 3, 2013
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University

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
Chronic Hepatitis C

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 : July 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Sustained virological response (SVR) [ Time Frame: 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 [ Time Frame: 4 weeks after start of treatment ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Jae-Gook Shin, Inje University Identifier: NCT01453244     History of Changes
Other Study ID Numbers: 11-037
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Jae-Gook Shin, Inje University:
Chronic hepatitis C

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