We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacogenomic Research in Korean Patients With Hepatitis C

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01453244
First Posted: October 17, 2011
Last Update Posted: June 3, 2013
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.
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
  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 Jae-Gook Shin, Inje University:

Primary Outcome Measures:
  • 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:
  • 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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier: NCT01453244     History of Changes
Other Study ID Numbers: 11-037
First Submitted: October 13, 2011
First Posted: October 17, 2011
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Jae-Gook Shin, Inje University:
Chronic hepatitis C
Pharmacogenomics
IL28B
ITPA

Additional relevant MeSH terms:
Hepatitis
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