A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with
 Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C
 infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid
 viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in
 the placebo group, when each is administered concomitantly with pegylated interferon
 (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated
 compared with placebo, when each is administered concomitantly with peg-IFN α-2a and
 ribavirin for 28 days.
Inclusion Criteria:

 -  Has chronic genotype 1 Hepatitis C infection

 Exclusion Criteria:

 -  Has not tolerated previous course of peg-IFN and ribavirin

 -  Has HIV

 -  Has Hepatitis B

 -  Has a history of clinically significant medical condition that may interfere with the
 study (e.g., stroke or chronic seizures or major neurological disorder) or is
 contraindicated for treatment with peg-IFN and ribavirin