Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Grazoprevir; Boceprevir; Placebo for Grazoprevir; Placebo for Boceprevir; Peg-interferon alfa-2b; Ribavirin
Intervention description: Orally once daily in AM. Blinded or open-label depending on treatment arm.; Four 200 mg capsules orally three times daily.; Orally once daily in AM.; Four capsules orally three times daily.; 1.5 μg/kg/week subcutaneous injection.; 300 mg to 700 mg orally twice daily.
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: 368.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir
      (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin
      (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has previously documented chronic hepatitis C genotype 1 (CHC GT 1) infection

          -  Has hepatitis C virus (HCV) ribonucleic acid (RNA value) ≥10,000 IU/mL

          -  Body weight ≥40 kg (88 lbs) and ≤125 kg (275 lbs)

          -  Absence (no medical history or physical findings) of ascites, bleeding esophageal
             varices, hepatic encephalopathy, or other signs and symptoms of decompensated liver
             disease

          -  Had a liver biopsy within 3 years of screening or between screening and Day 1 with
             histology consistent with CHC and no evidence of cirrhosis or hepatocellular carcinoma
             or no other cause for chronic liver disease (for participants with compensated
             cirrhosis, any liver biopsy demonstrating cirrhosis regardless of length of time since
             biopsy)

          -  Female of childbearing potential or a male with female sexual partner who is of
             childbearing potential agrees 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 participants with compensated cirrhosis, evidence of cirrhosis without evidence of
             hepatocellular carcinoma (confirmed by ultrasound within 4 weeks prior)

        Exclusion Criteria:

          -  Is pregnant, breastfeeding, or plans to become pregnant or donate eggs

          -  Is human immunodeficiency virus (HIV) positive or known to be co-infected with
             hepatitis B virus

          -  Has received prior approved or investigational treatment for hepatitis C

          -  Has evidence of hepatocellular carcinoma or is under evaluation for hepatocellular
             carcinoma

          -  For participants with compensated cirrhosis: alphafetoprotein level of ≥100 ng/mL

          -  Has evidence of active or suspected malignancy, or a history of malignancy, within the
             last 5 years

          -  Has evidence or history of chronic hepatitis not caused by HCV

          -  Is diabetic and/or hypertensive with clinically significant ocular examination
             findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or
             any other clinically significant abnormality

          -  Has any known medical condition that could interfere with participation in and
             completion of the study

          -  Pre-existing psychiatric condition including but not limited to moderate or severe
             depression, suicidal or homicidal ideation or attempt, schizophrenia, psychosis,
             bipolar disorder, post traumatic stress disorder, or mania

          -  Is currently participating or has participated in a study with an investigational
             compound or device within 30 days of signing informed consent

          -  Member or family member of study staff