Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)
Status:
Completed
Trial end date:
2016-05-16
Target enrollment:
Participant gender:
Summary
This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese
participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding
study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose
determined in Part I in combination with elbasvir. The primary study hypothesis is that the
percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who
achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be
greater than the reference rate of 75%. A separate study arm for cirrhotic participants will
also be included in Part II; these participants will receive grazoprevir at the determined
dose in combination with elbasvir.