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 |
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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