Pharmacogenomic Research in Korean Patients With Hepatitis C

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT01453244
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-17
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Inje University; 🇰🇷 Busan, Korea, Republic of