Efficacy and Safety of Combination MK-5172 + MK-8742 + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:October 2013
End Date:November 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase II Clinical Trial to Study the Efficacy and Safety of a Combination Regimen of MK-5172 and MK-8742 With Ribavirin (RBV) in Subjects With Chronic Hepatitis C Genotype 2 Infection

This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of
MK-5172 (a second-generation protease inhibitor) used in combination with/or without 50 mg
of MK-8742 (an NS54A inhibitor) and/or ribavirin (RBV) in treating non-cirrhotic
treatment-naïve (TN) participants with chronic genotype (GT) 2, 4, 5, and 6 hepatitis C
infection.


Inclusion Criteria:

Parts A and B:

- Body weight ≥50 kg (111 lbs) and ≤ 125 kg (275 lbs)

- Has absence of cirrhosis

- Agrees to use two acceptable methods of birth control from at least 2 weeks prior to
Day 1 and continue until at least 6 months after last dose of study drug, or longer
if dictated by local regulations (for female subject who is of childbearing potential
or male subject with female sexual partner who is of childbearing potential).

Part A only:

- Has chronic HCV GT2 infection

Part B only:

- Has chronic HCV GT2, GT4, GT5, or GT6 infection

Exclusion Criteria:

Parts A and B:

- Is not treatment naïve (participant has had previous treatment with any interferon,
RBV, approved or experimental direct acting antiviral(s), or other investigational
therapies for HCV)

- Is determined to be coinfected with hepatitis B virus (HBsAg positive) or HIV

- Has evidence of, or is under evaluation for, hepatocellular carcinoma (HCC)

- Has a clinical diagnosis of substance abuse including the following specified drugs
within specified timeframes: Alcohol, intravenous drugs, inhalational, psychotropics,
narcotics, cocaine use, prescription or over-the-counter drugs (within 1 year of the
screening visit), is receiving opiate agonist substitution therapy (within 1 year of
screening visit), or excessive historic marijuana use

- Has evidence of active or suspected malignancy, or a history of malignancy, within
the last 5 years

- Female participant who is pregnant, lactating, expecting to conceive or donate eggs,
or is of childbearing potential and unwilling to commit to two methods of birth
control throughout treatment and after the completion of all treatment, or male
participant who is planning to impregnate or provide sperm donation or has a female
sexual partner of childbearing potential and is unwilling to commit to using a two
methods of birth control throughout treatment and after the completion of all
treatment

- Has evidence or history of chronic hepatitis not caused by HCV, including but not
limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and
autoimmune hepatitis.

- Has uncontrolled diabetes (documented HbA1c >8.5%)

Part A only:

- Has non GT2 HCV infection

Part B only:

- Has HCV infection with a genotype other than GT2, GT4, GT5 or GT6
We found this trial at
8
sites
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New Orleans, LA
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