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
NCT ID: NCT02510300
Last Updated: 2023-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
461 participants
OBSERVATIONAL
2015-10-21
2023-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Sofosbuvir (SOF)
Exposure of interest for participants who received a SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Parent or legal guardian able to provide written informed consent OR individual is able to provide written informed consent prior to any study procedures and willing to comply with study requirements as determined by institutional review board (IRB)/independent ethics committee(IEC)/local requirements and Investigator's discretion.
* Individual is able to provide written assent, if they have the ability to read and write, as determined by IRB/IEC/local requirements and Investigator's discretion
Exclusion Criteria
* History of clinically-significant illness or any other major medical disorder that may interfere with the individual's follow-up, assessments or compliance with the protocol.
3 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles, Div. of Research Immunology/BMT
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Louisville School of Medicine
Louisville, Kentucky, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States
Saint Louis University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai Medical Center
New York, New York, United States
UNC Pediatrics/NC Children's Hospital
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
West Virginia University Children's Hospital
Morgantown, West Virginia, United States
John Hunter Children's Hospital (JHCH)
New Lambton Heights, New South Wales, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Cliniques Universitaires Saint- LUC UCL
Brussels, , Belgium
Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
Berlin, , Germany
Helios Klinikum Wuppertal
Wuppertal, , Germany
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer
Florence, , Italy
Polo Universitario - L'Azienda Ospedaliera Luigi Sacco
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliero-Universitaria di Padova
Padua, , Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, , Italy
Auckland Clinical Studies
Auckland, , New Zealand
Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego
Bydgoszcz, , Poland
MED. POLONIA Sp. z.o.o.
Poznan, , Poland
Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology
Moscow, , Russia
Federal Government Institution "Republican Clinical Infectious Hospital"
Saint Petersburg, , Russia
Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency
Saint Petersburg, , Russia
Ltd Medical Company "Hepatolog"
Tolyatti, , Russia
Birmingham Childrens Hospital NHS Trust
Birmingham, , United Kingdom
Royal Hospital for Sick Children Glasgow
Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
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References
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Gonzalez-Peralta RP, Wen JW, Hardikar W, Karnsakul WW, Whitworth S, Lin CH, Indolfi G, Rosenthal P, Balistreri W, Schwarz KB, Honegger JR, Zhang X, Svarovskaia EC, Suri V, Kersey K, Leung DH. Long-term efficacy and safety of sofosbuvir-based direct-acting antiviral regimens in paediatric patients with hepatitis C virus infection: an international registry study. Lancet Child Adolesc Health. 2025 Apr;9(4):248-254. doi: 10.1016/S2352-4642(25)00028-8.
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2014-004674-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-334-1113
Identifier Type: -
Identifier Source: org_study_id
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