Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
Status:
Completed
Trial end date:
2020-07-23
Target enrollment:
Participant gender:
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.