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Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)

NCT02203149 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2018-09-24

Study results available
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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.

Conditions

  • Hepatitis C

Interventions

DRUG

Grazoprevir

One or two 50 mg tablets (depending on randomization) taken orally once daily for 12 weeks.

DRUG

Elbasvir

One 50 mg tablet taken orally once daily for 12 weeks.

DRUG

Placebo to Grazoprevir

One tablet of placebo matched to grazoprevir, taken orally once daily for 12 weeks.

DRUG

Placebo to Elbasvir

One tablet of placebo matched to elbasvir, taken orally once daily for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2015-10-02
Completion
2016-05-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203149 on ClinicalTrials.gov