Clinical Trial Results:
A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 vs. placebo as part of a treatment regimen including peginterferon alfa-2a and ribavirin in treatment-naïve, genotype 1 hepatitis C-infected subjects
Summary
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EudraCT number |
2010-020444-36 |
Trial protocol |
GB DE IT ES |
Global completion date |
29 Jan 2013
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Jul 2016
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First version publication date |
20 Mar 2015
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Other versions |
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Summary report(s) |
2010-020444-36_TMC435-TIDP16-C208 (CR017386)_Basic Results |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.