Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
Condition: HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis C, Chronic
Intervention: EBR/GZR FDC Tablet; Placebo; Grazoprevir Oral Granules; Elbasvir Oral Granules
Intervention description: Participants who are 12 to <18 years of age will receive oral FDC tablets with EBR 50 mg/GZR 100 mg once daily by mouth.; Placebo tablet matched to EBR/GZR FDC tablet.; Participants 3 to <12 years of age take grazoprevir granules 0.5 mg by mouth in a soft food vehicle at a dose not to exceed 50 mg.; Participants 3 to <12 years of age take elbasvir oral granules 1 mg by mouth in a soft food vehicle at a dose not to exceed 100 mg.
Intervention MeSH terms: Grazoprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of
      oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and
      grazoprevir [GZR] 100 mg) and EBR/GZR (varying doses) pediatric granules in pediatric
      hepatitis C virus (HCV)-infected participants who are 3 to <18 years of age. Within each age
      cohort (Cohort 1: 12 to <18 years of age; Cohort 2: 7 to <12 years of age; and Cohort 3: 3 to
      <7 years of age), a Mini Cohort of 7 participants will be enrolled first. For the oldest
      cohort (Cohort 1), the Mini Cohort will assess ability to swallow a placebo tablet prior to
      administering active FDC tablets; participants in Cohorts 2 and 3 will take pediatric
      granules instead of a tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has documented chronic HCV genotype (GT) 1 or GT4 infection

          -  Has the following liver disease staging assessment: absence of cirrhosis or
             compensated cirrhosis

          -  Has one of the following HCV treatment statuses:

          -  GT1 and GT4: treatment-naïve (TN), defined as no prior exposure to any interferon
             (IFN)-containing regimen, ribavirin (RBV), or other HCV-specific direct acting
             antiviral (DAA) agent

          -  GT1 only: treatment-experienced (TE) with no previous treatment with HCV specific DAA
             agents.

          -  If female is not pregnant, not breastfeeding, and is either not of childbearing
             potential or follows the contraceptive guidance during the treatment period and for at
             least 14 days after the last dose of study treatment.

        Exclusion Criteria:

          -  Has evidence of decompensated liver disease manifested by the presence of or history
             of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other
             signs or symptoms of advanced liver disease.

          -  Is cirrhotic AND has a Child-Turcotte-Pugh score >6, corresponding to a Child Class B
             or C.

          -  Is co-infected with Human Immunodeficiency Virus (HIV).

          -  Has evidence of past or present hepatitis B infection.

          -  Has a history of malignancy ≤5 years prior to signing informed consent or is under
             evaluation for other active or suspected malignancy.

          -  Female expects to conceive or donate eggs from Day 1 through at least 14 days after
             the last dose of study treatment or longer.

          -  Has any of the following conditions: organ transplants other than cornea and hair;
             poor venous access; history of gastric surgery or malabsorption disorders; any
             clinically significant cardiac abnormalities/dysfunction that may interfere with
             participant treatment, assessment, or compliance; any major medical condition which
             might interfere with participant treatment, assessment, or compliance; history of a
             medical/surgical condition that resulted in hospitalization within the 3 months prior
             to enrollment; medical/surgical conditions that may result in a need for
             hospitalization during the study duration; any medical condition requiring, or likely
             to require, chronic systemic administration of corticosteroids, tumor necrosis factor
             antagonists, or immunosuppressant drugs; life-threatening serious adverse event (SAE)
             during the screening period; history of chronic hepatitis not caused by HCV.

          -  If female has a positive urine pregnancy test within 24 hours before the first dose of
             study treatment.

          -  Is taking or plans to take prohibited medications, or is taking herbal supplements.

          -  Has had previous HCV direct acting antiviral (DAA) treatment.

          -  Is currently participating or has participated in a study with an investigational
             compound within prior 30 days

          -  Has significant emotional problems or a clinically significant psychiatric disorder
             that may interfere with participant treatment, assessment, or compliance with the
             protocol.

          -  Has clinically relevant drug or alcohol abuse within prior 12 months that may
             interfere with participant treatment, assessment, or compliance.