A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Grazoprevir; Ribavirin
Intervention description: Grazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment; Ribavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight
Intervention MeSH terms: Ribavirin; Grazoprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare two different durations of treatment with grazoprevir (MK-5172) in
      combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible
      interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic
      hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic, compensated HCV GT 1 hepatitis C

          -  IL28B CC genotype

          -  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 and hepatocellular carcinoma by biopsy or noninvasive tests
             (FibroScan and/or FibroTest)

          -  Agree to use two acceptable methods of birth control from at least 2 weeks prior to
             Day 1 and continue until at least 6 months after last dose of study drug, or longer if
             dictated by local regulations (for female subject who is of childbearing potential or
             male subject with female sexual partner who is of childbearing potential)

        Exclusion Criteria:

          -  Non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a
             non-typeable genotype

          -  Previous treatment with any interferon, RBV, approved or experimental direct acting
             antiviral(s), or other investigational therapies for HCV

          -  Human immunodeficiency virus (HIV) positive or known to be co-infected with hepatitis
             B virus

          -  Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC

          -  Currently participating or has 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

          -  Diabetes and/or hypertension with clinically significant ocular examination findings

          -  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

          -  Clinical diagnosis of substance abuse

          -  Current or 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

          -  Poor venous access

          -  Indwelling venous catheter

          -  History of gastric surgery or malabsorption disorder

          -  Severe concurrent disease

          -  Evidence of active or suspected malignancy, or under evaluation for malignancy, or
             history of malignancy, within the last 5 years

          -  Pregnant, lactating, or expecting to conceive or donate eggs

          -  Male participant whose female partner is pregnant

          -  Member or a family member of the investigational study staff or sponsor staff directly
             involved with this study

          -  History of chronic hepatitis not caused by HCV