A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)

Merck Sharp & Dohme LLC90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hepatitis C

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants Achieving Rapid Viral Response

Rapid viral response (RVR) is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) at Week 4. Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The limit of quantification was 1.2 log IU/mL (15 IU/mL) and the limit of detection was \<1.2 log IU/mL, but with no specific value. The Data-As-Observed (DAO) approach was used to handle missing data.

Time frame: Week 4

Secondary Outcomes

Percentage of Participants Achieving a > or = 2-log10 Decrease in HCV RNA From Baseline to Week 4

Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.

Time frame: Baseline and Week 4

Percentage of Participants Achieving a > or = 3-log10 Decrease in HCV RNA From Baseline to Week 4

Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.

Time frame: Baseline and Week 4

Change From Baseline in HCV RNA in log10 at Week 4

Change from baseline in HCV RNA at Week 4 was calculated by subtracting Week 4 HCV RNA level from Baseline HCV RNA level. HCV RNA is measured as International Units per milliliter (IU/mL). Serum HCV RNA levels were measured using Roche COBAS TaqMan HCV Auto assay. The DAO approach was used to handle missing data.

Time frame: Baseline and Week 4

Number of Participants Who Experienced at Least One Adverse Event

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Time frame: Up to 6 weeks

Number of Participants Who Discontinued Study Drug Due to an Adverse Event

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Time frame: Up to 6 weeks