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 Houston Texas

Houston, Texas

from

Houston, TX