NCT03379506

Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)

A Phase IIb Clinical Study to Assess the Pharmacokinetics, Safety, and Efficacy of the Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Participants Aged 3 to Less Than 18 Years With Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	EBR/GZR FDC Tablet	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.
DRUG	Placebo	Placebo tablet matched to EBR/GZR FDC tablet.
DRUG	Grazoprevir Oral Granules	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.
DRUG	Elbasvir Oral Granules	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.

Timeline

• Start date: 2018-01-25
• Primary completion: 2019-10-28
• Completion: 2020-07-23
• First posted: 2017-12-20
• Last updated: 2023-05-31
• Results posted: 2020-08-17

Locations

15 sites across 4 countries: United States, Germany, Poland, Sweden

Regulatory

• FDA-regulated drug study