A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

March 20, 2017

Primary Completion Date

May 21, 2020

Study Completion Date

September 12, 2022

Conditions
Hepatitis C Virus (HCV)
Interventions
DRUG

Glecaprevir/Pibrentasvir Adult Formulation

Co-formulated film-coated tablet (100 mg/40 mg)

DRUG

Glecaprevir + Pibrentasvir Pediatric Formulation

Film-coated pellets/granules (15.67%/8.25%) administered by mixing with a small amount (1-2 teaspoons) of a soft food vehicle, such as hazelnut spread, Greek yogurt, or peanut butter.

Trial Locations (38)

1200

Cliniques Universitaires Saint Luc /ID# 162173, Woluwe-Saint-Lambert

3000

UZ Leuven /ID# 162174, Leuven

10117

Charite Universitaetsmedizin Berlin /ID# 165186, Berlin

19104

Children's Hospital of Philadelphia /ID# 158003, Philadelphia

27514

UNC Health Care /ID# 157991, Chapel Hill

28046

Hospital Universitario La Paz /ID# 163283, Madrid

32803

Advent Health /ID# 166022, Orlando

37232

Monroe-Carell Jr. Children's H /ID# 169037, Nashville

42283

Helios Klinikum Wuppertal /ID# 165185, Wuppertal

45229

Cincinnati Childrens Hosp Med /ID# 158007, Cincinnati

46026

Hospital Universitario y Politecnico La Fe /ID# 163325, Valencia

46202

Indiana University /ID# 158001, Indianapolis

79106

Universitatsklinikum Freiburg /ID# 165187, Freiburg im Breisgau

80045

Childrens Hospital Colorado /ID# 157996, Aurora

94158

Univ of California San Francis /ID# 158002, San Francisco

109240

Federal State Budgetary Institution - Institute of Nutrition /ID# 163345, Moscow

119296

National Medical Scientific Centre of children health /ID# 163344, Moscow

197022

Scientific and Research Institute of pediatric infections /ID# 163343, Saint Petersburg

06106

CT Childrens Medical Ctr, US /ID# 158639, Hartford

32610-0272

UF Hepatology Research at CTRB /ID# 158008, Gainesville

02115

Boston Childrens Hospital /ID# 157988, Boston

02118

Boston Medical Center /ID# 157997, Boston

10032-3725

Columbia Univ Medical Center /ID# 158000, New York

15213-2583

Child Hosp of Pittsburgh,PA /ID# 158004, Pittsburgh

77030-3411

Baylor College of Medicine /ID# 157989, Houston

T3B 6A9

Alberta Children's Hospital /ID# 163449, Calgary

T6G 2X8

Stollery Children's Hospital /ID# 163450, Edmonton

M5G 1X8

Hospital for Sick Children /ID# 163448, Toronto

830-0011

Kurume University Hospital /ID# 165718, Kurume-shi

558-8558

Osaka General Medical Center /ID# 212745, Osaka

565-0871

Osaka University Hospital /ID# 165709, Suita-shi

113-8431

Juntendo University Hospital /ID# 212912, Bunkyo-ku

00912-3310

San Jorge Children Hospital /ID# 160850, San Juan

08950

Hospital Sant Joan de Deu /ID# 163282, Esplugues de Llobregat

08035

Hospital Universitario Vall d'Hebron /ID# 163323, Barcelona

B4 6NH

Birmingham Childrens Hospital /ID# 162718, Birmingham

G514TF

Queen Elizabeth University Hos /ID# 162719, Glasgow

SE5 9RS

King's College Hospital NHS /ID# 162717, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY