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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
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.
University of California San Francisco ( Site 0020)
San Francisco, California, United States
Florida Hospital ( Site 0006)
Orlando, Florida, United States
Children's Center for Advanced Pediatrics ( Site 0204)
Atlanta, Georgia, United States
Children's Hospital Boston ( Site 0009)
Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center ( Site 0003)
Cincinnati, Ohio, United States
Children's Hospital of Pittsburgh ( Site 0024)
Pittsburgh, Pennsylvania, United States
American Research Corporation ( Site 0200)
San Antonio, Texas, United States
Children's Hospital and Regional Medical Center ( Site 0017)
Seattle, Washington, United States
Medizinische Hochschule Hannover Kinderklinik K10 ( Site 0105)
Hanover, Germany
Klinikum Starnberg ( Site 0107)
Starnberg, Germany
...and 5 more locations
Area Under the Plasma Concentration-Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of EBR at Steady State
The AUC0-24hr of EBR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Maximum Plasma Concentration (Cmax) of EBR
The Cmax of EBR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Steady State Predose Drug Concentration (Ctrough) of EBR
The Ctrough of EBR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
Time frame: Week 4: Predose
Apparent Clearance (CL/F) of EBR at Steady State
The CL/F of EBR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
AUC0-24hr of GZR at Steady State
The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Cmax of GZR
The Cmax of GZR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Ctrough of GZR
The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
Time frame: Week 4: Predose
CL/F of GZR at Steady State
The CL/F of GZR at steady state (Week 4) was determined in each cohort.
Time frame: Week 4: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Percentage of Participants With ≥1 Adverse Event (AE)
The percentage of participants with ≥1 AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 36 weeks
Percentage of Participants Discontinuing Study Treatment Due to an AE
The percentage of participants discontinuing study therapy due to an AE is reported in each cohort. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)
The percentage of participants achieving SVR12, defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks after completing study therapy, was determined in each cohort.
Time frame: Week 24
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