Pharmacogenomic Research in Korean Patients With Hepatitis C

Pharmacogenomic Research for Prediction of Drug Response in Korean Patients With Hepatitis C

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01453244

Enrollment

373

Registered

2011-10-17

Start date

2011-07-31

Completion date

2013-03-31

Last updated

2013-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C, Pharmacogenomics, IL28B, ITPA

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Sustained virological response (SVR)	24 weeks after the end of treatment	Undetectable HCV RNA in serum ( \<15 IU/ml ) 24 weeks after the end of treatment

Secondary

Measure	Time frame	Description
Anemia	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.

Countries

South Korea

Outcome results