Pharmacogenomic Research in Korean Patients With Hepatitis C
This study is currently recruiting participants.
Verified September 2012 by Inje University
Sponsor:
Inje University
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01453244
First received: October 13, 2011
Last updated: September 20, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
- a reduction in Hemoglobin of >3.0 g/dL
- a reduction in Hemoglobin levels to 10.0g/dL.
Biospecimen Retention: Samples With DNA
DNA extracted from blood
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | October 2012 |
| 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
Contacts
| Contact: Jae-Gook Shin, MD, PhD | +82-51-890-6709 | phshinjg@inje.ac.kr |
Locations
| Korea, Republic of | |
| Inje University | Recruiting |
| Busan, Korea, Republic of, 633-165 | |
| Contact: Jae-Gook Shin, M.D, phD 82-51-890-6709 phshinjg@inje.ac.kr | |
| Principal Investigator: Jae-Gook Shin, M.D, PhD | |
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: | September 20, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Inje University:
|
Chronic hepatitis C Pharmacogenomics IL28B ITPA |
Additional relevant MeSH terms:
|
Hepatitis C Hepatitis C, Chronic Hepatitis Hepatitis A Hepatitis, 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 May 21, 2013