TMC435-TiDP16-C216 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

Update Il y a 4 ans
Reference: EUCTR2010-021174-11

Woman and Man

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Extract

The primary objective is to demonstrate the superiority of TMC435 versus placebo as part of a treatment regimen including peginterferon alpha-2a (PegIFNα-2a)/ribavirin (RBV) or PegIFNα-2b/RBV, with respect to the proportion of treatment-naïve genotype 1 HCV-infected subjects with sustained virologic response (SVR) 12 weeks after the planned end of treatment (SVR12).


Inclusion criteria

  • Hepatitis C Virus (HCV) in treatment naïve patients