Efficacy and Safety of MK-3682 With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)



Status:Active, not recruiting
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/26/2017
Start Date:May 3, 2016
End Date:October 20, 2017

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A Phase II, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682 + MK-8408 in Subjects With Chronic HCV Genotype 1, 2, 3, 4, 5 or 6 Infection

The study is a single-center, multiple-arm investigation of co-administration of MK-3682 450
mg and Ruzasvir (MK-8408) 60 mg in participants with chronic Hepatitis C Virus (HCV)
Genotype (GT)1, GT2, GT3, GT4, GT5, or GT6. The impact of the study treatment regimen on
Sustained Virologic Response (SVR)12 (undetectable HCV ribonucleic acid [RNA] 12 weeks after
ending study treatment) for each HCV Genotype will be evaluated in cirrhotic participants
and non-cirrhotic participants.


Inclusion Criteria:

- Has Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the time of screening

- Has documented chronic HCV Genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 with no
evidence of non-typeable or mixed GT infection

- Is otherwise healthy as determined by the medical history, physical examination,
electrocardiogram (ECG), and clinical laboratory measurements performed at the time
of screening

- Has absence of cirrhosis or has compensated cirrhosis

- Is HCV treatment-naïve or has experienced virologic failure after completing a prior
interferon-containing regimen

- Is of non-childbearing potential or agrees to avoid becoming pregnant or impregnating
a partner beginning at least 2 weeks prior to administration of the initial dose of
study drug and for 14 days after the last dose of study drug

- For human immunodeficiency virus (HIV) co-infected participants: is not currently on
antiretroviral therapy (ART) and has no plans to initiate ART treatment while
participating in this study Or has well-controlled HIV on ART

Exclusion Criteria:

- Is mentally or legally incapacitated, has significant emotional problems (at
screening or expected during the study) or has a history of a clinically significant
psychiatric disorder that would interfere with the study procedures.

- Has evidence of decompensated liver disease manifested by the presence of or history
of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other
signs or symptoms of advanced liver disease

- Is Child-Pugh Class B or C or has a Pugh-Turcotte (CPT) score >6 if cirrhotic

- Is co-infected with Hepatitis B Virus

- Has a history of opportunistic infection in the preceding 6 months prior to screening
if co-infected with HIV

- Has a history of malignancy ≤5 years prior to study start (except for adequately
treated basal cell or squamous cell skin cancer or in situ cervical cancer or
carcinoma in situ) or is under evaluation for other active or suspected malignancy

- Has cirrhosis and liver imaging within 6 months prior to study start showing evidence
of hepatocellular carcinoma (HCC) or is under evaluation for HCC

- Is taking any medications or herbal supplements restricted by the study entry
criteria in the period from ≤2 weeks prior to study start through 2 weeks after the
last dose of study drug

- Has clinically-relevant drug or alcohol abuse within 12 months of study start

- Has participated in any clinical study of an investigational product within 30 days
prior to the first dose of study drug

- Is female and is pregnant or breastfeeding, or expecting to conceive or donate eggs
from at least 2 weeks prior to study start and 14 days after the last dose of study
drug

- Is male and is expecting to donate sperm from at least 2 weeks prior to Day 1 until
14 days after the last dose of study drug

- Has or has had any of the following: organ transplants (including hematopoietic stem
cell transplants) other than cornea and hair; poor venous access; history of gastric
surgery; or history of malabsorption disorders

- Has any cardiac abnormalities/dysfunction including but not limited to: unstable
angina; unstable congestive heart failure; or unstable arrhythmia

- Has a history of a medical/surgical condition that resulted in hospitalization within
3 months prior to study start, other than for minor elective procedures

- Has any medical condition requiring, or likely to require, chronic systemic
administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other
immunosuppressant drugs during the study

- Has evidence of history of chronic hepatitis not caused by HCV
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