At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C and a Phase III, Randomized Placebo-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of the Combination Regimen of MK-5172 and MK-8742 in Japanese Subjects With Chronic Hepatitis C
In Brief
A Phase 3 clinical trial evaluating Grazoprevir, Elbasvir, and 2 other interventions for Hepatitis C. Completed, enrolled 399 participants.
Detailed 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.
Study Details
Timeline
Interventions
One or two 50 mg tablets (depending on randomization) taken orally once daily for 12 weeks.
One 50 mg tablet taken orally once daily for 12 weeks.
One tablet of placebo matched to grazoprevir, taken orally once daily for 12 weeks.
One tablet of placebo matched to elbasvir, taken orally once daily for 12 weeks.