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
  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:


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 April 17, 2014