Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Hepatitis C, Chronic

Treatments

Drug: ribavirin

Drug: vaniprevir

Drug: Placebo to vaniprevir

Biological: Peg-IFN

Study type

Interventional

Funder types

Industry

Identifiers

NCT01370642

7009-043

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. 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 arms is superior to the percentage of participants achieving SVR24 in the control arm.

Enrollment

294 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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.
IFN treatment naive
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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

294 participants in 3 patient groups

Vaniprevir 12 Week Arm

Experimental group

Description:

Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.

Treatment:

Biological: Peg-IFN

Drug: ribavirin

Drug: vaniprevir

Drug: Placebo to vaniprevir

Vaniprevir 24 Week Arm

Experimental group

Description:

Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.

Treatment:

Biological: Peg-IFN

Drug: ribavirin