Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03379506 | Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079) | PHASE2 | COMPLETED | 57 | — | — | Jan 25, 2018 | Jul 23, 2020 | May 31, 2023 | 15 | United States, Germany +2 |
The AUC0-24hr of EBR at steady state (Week 4) was determined in each cohort.
The Cmax of EBR at steady state (Week 4) was determined in each cohort.
The Ctrough of EBR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
The CL/F of EBR at steady state (Week 4) was determined in each cohort.
The AUC0-24hr of GZR at steady state (Week 4) was determined in each cohort.
The Cmax of GZR at steady state (Week 4) was determined in each cohort.
The Ctrough of GZR at steady state (Week 4) was determined at steady state prior to dosing in each cohort.
The CL/F of GZR at steady state (Week 4) was determined in each cohort.
| Arm | Type | Description |
|---|---|---|
| EBR/GZR | EXPERIMENTAL | Pediatric participants receive EBR/GZR as either FDC tablets or oral granules once daily for 12 weeks. A 24-week follow-up period will follow the 12-week treatment regimen. |
| Name | Type | Description |
|---|---|---|
| EBR/GZR FDC Tablet | DRUG | 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 | DRUG | Placebo tablet matched to EBR/GZR FDC tablet. |
| Grazoprevir Oral Granules | DRUG | 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. |
| Elbasvir Oral Granules | DRUG | 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. |
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 ...