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A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naïve Patient...

Update Il y a 4 ans
Reference: EUCTR2008-000149-72

A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naïve Patients With Chronic Hepatitis C Infection

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Extract

To evaluate the activity, as measured by the proportion of patients achieving RVR (undetectable viral load at Week 4), and the safety and tolerability, as assessed by review of the accumulated safety data, of MK-7009 compared with placebo when each are administered concomitantly with peg-IFN and ribavirin for 28 days in treatment-naïve patients with chronic HCV genotype 1 infection with pre-treatment HCV RNA of at least 4 x 10e5 IU/mL.

Inclusion criteria

  • Chronic Hepatitis C Infection

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