Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)

• Status: Completed
• Trial end date: 2016-06-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.

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

Details

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

Criteria

Inclusion Criteria:

• has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease

• has cirrhosis or is non-cirrhotic

• is human immunodeficiency virus (HIV) coinfected or not infected with HIV

• is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception

Exclusion Criteria:

• has evidence of decompensated liver disease

• is coinfected with hepatitis B

• has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

• has hepatocellular carcinoma (HCC) or is under evaluation for HCC

• has clinically-relevant drug or alcohol abuse within 12 months of screening