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)
Condition: Chronic Hepatitis C (CHC)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Grazoprevir; pegylated interferon alfa-2b; Ribavirin; Placebo
Intervention description: Grazoprevir tablet, orally, once per day at assigned dose; 1.5 mcg/kg/week, administered as a weekly subcutaneous (SC) injection; Ribavirin capsule, orally, twice daily, at a dose of 800 to 1400 mg based on participant weight; Placebo to match grazoprevir tablets to maintain dose blinding
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Grazoprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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