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A Phase II Randomised, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK 7009 when administered concomitantly with Pegylated Interferon and Ribavi...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-012000-10

A Phase II Randomised, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK 7009 when administered concomitantly with Pegylated Interferon and Ribavirin in treatment- naive patients with chronic genotype I Hepatitis C Virus Infection

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Extrait

To evaluate the antiviral activity of the MK-7009 b.i.d. treatment regimens with 24 weeks of total duration (treatment regimens 1 to 4) as compared with placebo in combination with 48 weeks of peg-IFN and RBV (hereafter referred to as the control regimen), as assessed by the proportion of patients achieving undetectable HCV RNA 24 weeks after the end of all study therapy (Sustained Viral Response 24 [SVR24]). To evaluate the safety and tolerability of the MK-7009 treatment regimens as compared with the control regimen, as assessed by review of the accumulated safety data.

Critère d'inclusion

  • Chronic Hepatitis C Infection

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