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3-year Follow-up Study in Patients Previously Treated With a TMC435 for the Treatment of Hepatitis C Virus (HCV) Infection

Hepatitis C Clinical Trial

Official title:
A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection

Clinical Trial Summary

The purpose of this study is to investigate TMC435 for the treatment of chronic hepatitis C virus (HCV) infection.

Clinical Trial Description

This is a 3-year follow-up study in patients who completed a previous Phase II or III study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each participant will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last planned visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01349465
Study type Interventional
Source Janssen R&D Ireland
Contact
Status Completed
Phase Phase 3
Start date July 2011
Completion date January 2016
View Details
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