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

Status:	Recruiting
Conditions:	Hepatitis, Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	7/11/2015
Start Date:	October 2014
End Date:	June 2016
Contact:	Toll Free Number
Phone:	1-888-577-8839

A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic HCV GT1, GT4 and GT6 Infection With Inherited Blood Disorders With and Without HIV Co-Infection

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%.

Inclusion Criteria:

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

- Has cirrhosis or is non-cirrhotic

- 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

We found this trial at

sites

Clinical Trial Facility in New York New York

New York, New York 10032

from

New York, NY