Other clinical trials
This is a study of the safety and efficacy of MK-5172 in combination with MK-8742 ±
ribavirin (RBV). Description:
Part A is being done in treatment-naïve (TN), genotype 1 (GT1), interferon eligible,
non-cirrhotic (N-C) participants with chronic hepatitis C (CHC). Participants will be
assigned randomly to 1 of 2 treatment arms in which they will receive MK-5172 100 mg once
daily (QD) + MK-8742 20 mg or 50 mg QD and twice daily (BID) RBV, or to a treatment arm in
which they will receive MK-5172 100 mg QD + MK-8742 50 mg QD without RBV. Treatment will
last 12 weeks.
In Part B, participants with hepatitis C virus (HCV) GT1 and HCV ribonucleic acid (RNA)
levels of =10,000 IU/mL will be randomly assigned to a study arm, based on absence or
presence of cirrhosis (C), whether they are TN or had poor response to previous antiviral
therapy (null responders [NR]), or whether co-infected with human immunodeficiency virus
(HIV); these participants will receive MK-5172 in combination with MK-8742 50 mg ± RBV.
Treatment will last 8 to 18 weeks dependent on arm assignment.
In Part C, TN, N-C participants with HCV GT1b and HCV RNA levels of =10,000 IU/mL will be
randomly assigned to receive MK-5172 in combination with MK-8742 50mg ± RBV. Treatment will
last 8 weeks. Eligibility:
Age: 18 Years - N/A
Inclusion criteria: All participants - CHC genotype 1 virus infection - Female participants of childbearing potential or male participant with female partners of childbearing potential, must use two acceptable methods of birth control from =2 weeks prior to Day 1 until =6 months after last dose of study drug, or longer if dictated by local regulations Part A - 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 advanced fibrosis, cirrhosis and/or hepatocellular carcinoma by biopsy or noninvasive testing (FibroScan and/or FibroTest) Parts B & C - Treatment naïve with or without cirrhosis, or - Prior treatment failure to Peg-IFN/Ribavirin with or without cirrhosis, or - Co-infected with human immunodeficiency virus (HIV) without cirrhosis -Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease - Liver disease staging assessment by liver biopsy or noninvasive testing (FibroScan and/or FibroTest)
Exclusion criteria: All participants: - Non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype - Evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC - Currently participating or participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study - Diabetic and/or hypertensive with clinically significant ocular examination findings - History of depression associated with hospitalization for depression, electroconvulsive therapy, or resulting in prolonged absence from work and/or significant disruption of daily functions - Suicidal or homicidal ideations and/or attempt, or history of severe psychiatric disorders - Clinical diagnosis of substance abuse - Current history of seizure disorder, stroke, or transient ischemic attack - Immunologically mediated disease - Chronic pulmonary disease - Clinically significant cardiac abnormalities/dysfunction - Active clinical gout within the last year - Hemoglobinopathy or myelodysplastic syndromes - History of organ transplants including hematopoietic stem cell transplants - Poor venous access - Indwelling venous catheter - History of gastric surgery or malabsorption disorders - Severe concurrent disease - Evidence of active or suspected malignancy, or a history of malignancy, =5 years before - Pregnant, lactating, expecting to conceive or donate eggs - Male participant with pregnant female partner - Member/family member of the investigational study or sponsor staff directly involved with this study - Evidence or history of chronic hepatitis not caused by HCV Part A - Not treatment-naïve - Documented to be HIV positive - Taking or planning to take significant inducers or inhibitors of CYP3A4 substrates or herbal supplements 2 weeks prior to start of study medications Parts B & C - Previously received any HCV direct-acting antivirals - Requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial - For participants diagnosed with diabetes mellitus, documented HbA1c >8.5% Outcome:
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