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

PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

January 25, 2018

Primary Completion Date

October 28, 2019

Study Completion Date

July 23, 2020

Conditions
HCV Infection
Interventions
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.

Trial Locations (15)

15224

Children's Hospital of Pittsburgh ( Site 0024), Pittsburgh

30329

Children's Center for Advanced Pediatrics ( Site 0204), Atlanta

30625

Medizinische Hochschule Hannover Kinderklinik K10 ( Site 0105), Hanover

32803

Florida Hospital ( Site 0006), Orlando

42283

Helios Klinikum Wuppertal GmbH ( Site 0104), Wuppertal

45229

Cincinnati Children's Hospital Medical Center ( Site 0003), Cincinnati

78215

American Research Corporation ( Site 0200), San Antonio

82319

Klinikum Starnberg ( Site 0107), Starnberg

94158

University of California San Francisco ( Site 0020), San Francisco

98105

Children's Hospital and Regional Medical Center ( Site 0017), Seattle

02115

Children's Hospital Boston ( Site 0009), Boston

85-030

WSOZ im.T.Browicza w Bydgoszczy ( Site 0800), Bydgoszcz

91-347

Wojewodzki Specjalistyczny Szpital im. dr W. Bieganskiego w Lodzi ( Site 0810), Lodz

60-693

MED-POLONIA Sp. z o.o. ( Site 0808), Poznan

141 86

Karolinska Universitetssjukhuset Huddinge. ( Site 0062), Stockholm

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03379506 - Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079) | Biotech Hunter | Biotech Hunter