Clinical Trial Results:
A Phase IIb, randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including PegIFNα-2a and ribavirin in HCV genotype 1 infected subjects who failed to respond or relapsed following at least 1 course of PegIFNα-2a/b and RBV therapy.
Summary
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EudraCT number |
2009-010590-20 |
Trial protocol |
BE DE PT AT GB FR |
Global completion date |
17 Aug 2011
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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 |
28 Jul 2016
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First version publication date |
28 Jul 2016
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Other versions |
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Summary report(s) |
TMC435-TIDP16-C206 (2009-010590-20)_ct.gov 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.