Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
This trial is active, not recruiting.
|Sponsor||Merck Sharp & Dohme Corp.|
|Start date||January 2015|
|End date||September 2016|
|Trial size||489 participants|
|Trial identifier||NCT02251990, 5172-067|
This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype (GT) 1, 4 or 6 infection. The primary hypothesis is that the proportion of participants receiving grazoprevir/elbasvir FDC in the immediate treatment arm achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy) will be superior to the reference rate of 73%.
|Intervention model||parallel assignment|
Proportion of participants achieving SVR12
time frame: Week 24
Number of participants experiencing an adverse event (AE)
time frame: Up to Week 14
Number of participants discontinuing from study therapy due to AEs
time frame: Up to Week 12
Proportion of participants achieving SVR 4 weeks after ending all study treatment (SVR4)
time frame: Week 16
Proportion of participants achieving SVR 24 weeks after ending all study treatment (SVR24)
time frame: Week 36
All participants at least 18 years old.
Inclusion Criteria: - Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection - Has or does not have cirrhosis of the liver - Is abstinent or uses acceptable method(s) of contraception Exclusion Criteria: - Has evidence of decompensated liver disease - Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV) - Shows evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC - Has a clinically-relevant drug or alcohol abuse within 12 months of screening - Is pregnant or breast-feeding - Has any condition or abnormality that might confound the results of the trial or pose an additional risk to the subject
|Official title||A Phase III Randomized Multinational Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects With Chronic HCV GT 1, GT 4 and GT 6 Infection|
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