Study Stopped
The study stopped early because the study objectives were met.
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
A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
2 other identifiers
observational
461
9 countries
51
Brief Summary
This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry is to determine the long-term safety of anti-HCV regimens in the pediatric population. Secondary objectives of this Registry are to determine whether subsequent detection of HCV RNA in participants who relapse following sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection, and to characterize resistance mutations and the persistence of resistance mutations in pediatric participants who did not achieve SVR. Once enrolled, participants will be followed for up to 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedStudy Start
First participant enrolled
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2023
CompletedJanuary 27, 2023
January 1, 2023
7.2 years
July 27, 2015
January 25, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Growth data as measured by body height
Up to 5 years
Growth data as measured by body weight
Up to 5 years
Development as measured by Tanner Pubertal Stage Assessment
Up to 5 years
Interventions
Exposure of interest for participants who received a SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
Exposure of interest for participants who received a LDV/SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
Exposure of interest for participants who received a SOF/VEL-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
Exposure of interest for participants who received a SOF/VEL/VOX-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
Eligibility Criteria
Individuals who participated in a Gilead-sponsored chronic hepatitis C study as an adolescent or pediatric participant and received at least one Gilead HCV direct acting antiviral (DAA)
You may qualify if:
- Have previously participated in a Gilead-sponsored chronic hepatitis C study as an adolescent or pediatric participant and received at least one Gilead HCV direct acting antiviral
- 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
You may not qualify if:
- Individual is currently receiving or plans to initiate a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (51)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital Los Angeles, Div. of Research Immunology/BMT
Los Angeles, California, 90027, United States
University of California San Francisco
San Francisco, California, 94158, United States
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Louisville School of Medicine
Louisville, Kentucky, 40202, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
Saint Louis University School of Medicine
St Louis, Missouri, 63104, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
UNC Pediatrics/NC Children's Hospital
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Cook Children's Health Care System
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
West Virginia University Children's Hospital
Morgantown, West Virginia, 26506, United States
John Hunter Children's Hospital (JHCH)
New Lambton Heights, New South Wales, 2305, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
The Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Cliniques Universitaires Saint- LUC UCL
Brussels, 1200, Belgium
Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
Berlin, 13353, Germany
Helios Klinikum Wuppertal
Wuppertal, 42283, Germany
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer
Florence, 50139, Italy
Polo Universitario - L'Azienda Ospedaliera Luigi Sacco
Milan, 20157, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Azienda Ospedaliero-Universitaria di Padova
Padua, 35128, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Auckland Clinical Studies
Auckland, 1010, New Zealand
Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego
Bydgoszcz, 85-030, Poland
MED. POLONIA Sp. z.o.o.
Poznan, 60-693, Poland
Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology
Moscow, 111123, Russia
Federal Government Institution "Republican Clinical Infectious Hospital"
Saint Petersburg, 196645, Russia
Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency
Saint Petersburg, 197022, Russia
Ltd Medical Company "Hepatolog"
Tolyatti, 445009, Russia
Birmingham Childrens Hospital NHS Trust
Birmingham, B4 6NH, United Kingdom
Royal Hospital for Sick Children Glasgow
Glasgow, G3 8SJ, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Related Publications (1)
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.
PMID: 40113366DERIVED
Related Links
Biospecimen
Blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2015
First Posted
July 29, 2015
Study Start
October 21, 2015
Primary Completion
January 6, 2023
Study Completion
January 6, 2023
Last Updated
January 27, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/