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

• Status: Completed
• Trial end date: 2014-01-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

Criteria

Inclusion Criteria:

• Treatment naive

• Chronic, compensated HCV GT1 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 Human Immunodeficiency Virus (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 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