A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials

TerminatedOBSERVATIONAL
Enrollment

461

Participants

Timeline

Start Date

October 21, 2015

Primary Completion Date

January 6, 2023

Study Completion Date

January 6, 2023

Conditions
Hepatitis C Virus Infection
Interventions
DRUG

Sofosbuvir (SOF)

Exposure of interest for participants who received a SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

DRUG

Ledipasvir/Sofosbuvir (LDV/SOF)

Exposure of interest for participants who received a LDV/SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

DRUG

Sofosbuvir/Velpatasvir (SOF/VEL)

Exposure of interest for participants who received a SOF/VEL-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

DRUG

Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)

Exposure of interest for participants who received a SOF/VEL/VOX-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

Trial Locations (51)

1010

Auckland Clinical Studies, Auckland

1200

Cliniques Universitaires Saint- LUC UCL, Brussels

2145

The Children's Hospital at Westmead, Westmead

2305

John Hunter Children's Hospital (JHCH), New Lambton Heights

3052

The Royal Children's Hospital, Parkville

10029

Mount Sinai Medical Center, New York

10126

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino, Torino

13353

Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum, Berlin

19104

The Children's Hospital of Philadelphia, Philadelphia

20010

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

20157

Polo Universitario - L'Azienda Ospedaliera Luigi Sacco, Milan

21287

Johns Hopkins University School of Medicine, Baltimore

26506

West Virginia University Children's Hospital, Morgantown

27599

UNC Pediatrics/NC Children's Hospital, Chapel Hill

30322

Children's Healthcare of Atlanta at Egleston, Atlanta

32610

University of Florida, Gainesville

32803

AdventHealth Orlando, Orlando

35128

Azienda Ospedaliero-Universitaria di Padova, Padua

37232

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

40138

Policlinico Sant'Orsola Malpighi, Bologna

40202

University of Louisville School of Medicine, Louisville

42283

Helios Klinikum Wuppertal, Wuppertal

43205

Nationwide Children's Hospital, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

50139

Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer, Florence

63104

Saint Louis University School of Medicine, St Louis

64108

Children's Mercy Hospital and Clinics, Kansas City

68198

University of Nebraska Medical Center, Omaha

71013

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

75235

Children's Medical Center Dallas, Dallas

76104

Cook Children's Health Care System, Fort Worth

77030

Texas Children's Hospital, Houston

78215

Texas Liver Institute, San Antonio

80045

Children's Hospital of Colorado, Aurora

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

85016

Phoenix Children's Hospital, Phoenix

90027

Children's Hospital Los Angeles, Div. of Research Immunology/BMT, Los Angeles

94158

University of California San Francisco, San Francisco

98105

Seattle Children's Hospital, Seattle

111123

Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology, Moscow

196645

"Federal Government Institution Republican Clinical Infectious Hospital", Saint Petersburg

197022

Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency, Saint Petersburg

445009

"Ltd Medical Company Hepatolog", Tolyatti

02115

Boston Children's Hospital, Boston

85-030

Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego, Bydgoszcz

60-693

MED. POLONIA Sp. z.o.o., Poznan

B4 6NH

Birmingham Childrens Hospital NHS Trust, Birmingham

G3 8SJ

Royal Hospital for Sick Children Glasgow, Glasgow

LS9 7TF

Leeds Teaching Hospitals NHS Trust, Leeds

SE5 9RS

King's College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY