A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)
Completed
Merck Sharp & Dohme Corp.
Phase 2
2013-02-07
This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with
elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained
Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the
treatment arms.
Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)
Completed
Merck Sharp & Dohme Corp.
Phase 2
2013-10-01
This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of
grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or
ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype
(GT) 2, 4, 5, and 6 hepatitis C infection.
In Part A there is no randomization or stratification; all GT2 participants will be assigned
to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants
with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with
stratification by genotype.
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
Completed
Merck Sharp & Dohme Corp.
Phase 1
2013-09-06
Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of
combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic
(PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with
end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal
impairment. Both groups were compared to healthy matched controls.
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