Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)
Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
 given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin
 (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous
 therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage
 of participants achieving sustained virologic response 24 weeks after completion of all study
 therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is
 greater than 20% (historical data of standard of care treatment).
Inclusion Criteria:

 -  Japanese participant diagnosed with compensated CHC GT 1

 -  Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other
 signs or symptoms of advanced liver disease

 -  Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN)
 with or without use of ribavirin, but failed to respond to the prior treatment
 (relapse or breakthrough)

 -  No evidence of cirrhosis

 Exclusion Criteria:

 -  Co-infection with human immunodeficiency virus (HIV)

 -  Positive hepatitis B surface antigen or other evidence of active hepatitis B infection

 -  Any other condition that is contraindicated or for which caution is required for
 treatment with peg-IFN or RBV

 -  Any condition or pre-study laboratory abnormality, or history of any illness, that, in
 the opinion of the investigator, might confound the results of the study or pose
 additional risk in administering the study drugs, peg-IFN and RBV, to the participant