Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EBR/GZR · 1 trial · 1 indication
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 ...
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EBR/GZR is a fixed-dose combination tablet of elbasvir (EBR) and grazoprevir (GZR) developed by Merck & Company, Inc. (ticker: MRK) for the treatment of hepatitis C virus (HCV) infection. It is a small molecule therapeutic in the infectious disease area and is also known as the EBR/GZR FDC Tablet.
EBR/GZR is being studied for the treatment of chronic hepatitis C virus (HCV) infection. The clinical program includes a Phase 2 trial in pediatric participants aged 3 years and older with chronic HCV infection. It is an investigational fixed-dose combination of elbasvir and grazoprevir.
EBR/GZR is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program evaluating the elbasvir and grazoprevir fixed-dose combination in hepatitis C infection.
EBR/GZR is in Phase 2 clinical development. The program includes one completed Phase 2 trial in pediatric participants with chronic hepatitis C infection. There are currently no active trials listed for this asset.
EBR/GZR has been evaluated in one completed Phase 2 trial, NCT03379506, titled Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079). The trial enrolled 57 participants across the United States, Germany, Poland, and Sweden, with participants aged 3 years and older.