Clinical Trial Results:
Estudio en fase III, aleatorizado, doble ciego y controlado con placebo para investigar la eficacia, la seguridad y la tolerabilidad de TMC435 frente a placebo como parte de un régimen de tratamiento que incluye peginterferón alfa-2a (Pegasys®) y ribavirina (Copegus®) o peginterferón alfa-2b (PegIntron®) y ribavirina (Rebetol®) en sujetos infectados por el virus de la hepatitis C, genotipo 1, no tratados previamente.
A Phase III, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of TMC435 versus placebo as part of a treatment regimen including peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon alfa-2b (PegIntron®) and ribavirin (Rebetol®) in treatment-naïve, genotype 1, hepatitis C-infected subjects.
Summary
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EudraCT number |
2010-021174-11 |
Trial protocol |
ES DE PT BE SK AT PL BG |
Global completion date |
05 Feb 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 |
22 Jan 2015
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Other versions |
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Summary report(s) |
TMC435-TiDP-C216_2010-021174-11_Synopsis |
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.