A Study of Different Doses of MK-5172 Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038 AM1)



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:December 2012
End Date:January 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase II Randomized, Dose Ranging, Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of Different Doses of MK-5172 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection


This is a study designed to compare the safety and efficacy of 3 different doses of MK-5172
combined with pegylated interferon alfa-2b (PegIFN-2b) and ribavirin (RBV) in
treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants
will receive 12 weeks of treatment with MK-5172 combined with PegIFN-2b and RBV, and
depending on response at Week 4 may go on to receive an additional 12 weeks of treatment
with PegIFN-2b and RBV.


Inclusion Criteria:

- Treatment naive

- Chronic, compensated HCV GT 1 infection

- Absence (no medical history or physical findings) of ascites, bleeding esophageal
varices, hepatic encephalopathy, or other signs or symptoms of advanced liver
disease, or cirrhosis

- No evidence of cirrhosis or hepatocellular carcinoma by biopsy or noninvasive testing
(e.g. FibroScan and/or FibroTest)

- Must agree to use two acceptable methods of birth control from at least 2 weeks prior
to first dose and continue until at least 6 months after last dose of study drug, or
longer if dictated by local regulations

Exclusion Criteria:

- Non-GT1 HCV infection, including a mixed GT infection (with a non-GT1) or a
non-typeable genotype.

- Documented to be HIV positive or co-infected with hepatitis B virus

- Hepatocellular carcinoma (HCC) or under evaluation for HCC

- Participating in or has participated in a study with an investigational compound or
device within 30 days of signing informed consent

- Diabetic and/or hypertensive with clinically significant ocular examination findings

- Current or history of central nervous system (CNS) trauma, seizure disorder, stroke
or transient ischemic attack

- Chronic pulmonary disease

- Current or history of any clinically significant cardiac abnormalities/dysfunction

- Active clinical gout within the last year

- History of gastric surgery or history of malabsorption disorders

- Active or suspected malignancy, or a history of malignancy, within the last 5 years
(except adequately treated carcinoma in situ and basal cell carcinoma of the skin)

- Pregnant, lactating, expecting to conceive or donate eggs or male participant
planning to impregnate or provide sperm donation or with a female partner who is
pregnant

- Current moderate or severe depression or history of depression associated with
hospitalization, electroconvulsive therapy, or severe disruption of daily functions,
or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric
disorders

- Evidence or history of chronic hepatitis not caused by HCV
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