Pharmacogenomic Research in Korean Patients With Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453244
• Other study ID #: 11-037
• Status: Completed
• Phase: N/A
• First received: October 13, 2011
• Last updated: May 30, 2013
• Start date: July 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Inje University	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR)	Undetectable HCV RNA in serum ( <15 IU/ml ) 24 weeks after the end of treatment	24 weeks after the end of treatment	No
Secondary	Anemia	a reduction in Hemoglobin of >3.0 g/dL; a reduction in Hemoglobin levels to 10.0g/dL.	4 weeks after start of treatment	Yes