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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2011
End Date:January 2016

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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

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

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.

Inclusion Criteria:

- Have previously participated in a Phase II or Phase III study

- Must have received at least one dose of TMC435 in that study

- Has completed the last patient visit of the previous study

Exclusion Criteria:

- Must be currently enrolled or plan to enroll in another study with an investigational
drug or invasive investigational medical device

- Have received antiviral or immunomodulating treatment for hepatitis C virus (HCV)
between last visit previous study and this study
We found this trial at
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