Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)

• Status: Completed
• Trial end date: 2017-04-10
• Target enrollment: 0
• Participant gender: All

Summary

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 percentage of participants receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to the historical reference rate of 73%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir

Criteria

Inclusion Criteria:

• Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection

• Meets clinical criteria for presence or absence of cirrhosis based on liver disease staging assessment

• 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 participant