Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

January 26, 2017

Primary Completion Date

November 19, 2019

Study Completion Date

February 26, 2020

Conditions
Hepatitis C Virus Infection
Interventions
DRUG

SOF/VEL

SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)

DRUG

SOF/VEL

SOF/VEL FDC 200/50 mg oral granules

Trial Locations (27)

1200

Cliniques Universitaires Saint Luc, Brussels

10029

Mount Sinai Medical Center, New York

19104

The Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins University (JHU) - The Johns Hopkins Hospital (JHH), Baltimore

30322

Emory Children's Center, Atlanta

32610

University of Florida Shands Medical, Gainesville

32803

Florida Gastroenterology Care for Children, Orlando

37232

Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S. Orsola - Malpighi, Bologna

40202

Kosair Charities Pediatric Clinical Research Unit, Louisville

43205

Nationwide Children's Hospital- The Ohio State University (OSU), Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

50139

Azienda Ospedaliera Universitaria Meyer, Florence

64108

Children's Mercy Hospital, Kansas City

71013

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine, Houston

80045

Children's Hospital of Colorado, Aurora

90027

Children's Hospital Los Angeles, Los Angeles

94158

University of California, San Francisco, San Francisco

98105

Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

68198-5331

Children's Hospital & Medical Center, Omaha

LS1 3EX

The Leeds Teaching Hospitals NHS Trust, Leeds

SE5 9RS

King's College Hospital NHS Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY