OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
3 years +
Sex
All
Healthy Volunteers
No
Age
3 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Hepatitis C Virus Infection
Gender
N/A
Date
October 2015 - January 2023
Study Type
Observational
Study Phase
Product
Sofosbuvir (SOF), Ledipasvir/Sofosbuvir (LDV/SOF), Sofosbuvir/Velpatasvir (SOF/VEL), Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)
Eligibility information
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (51)
Children's Hospital Los Angeles, Div. of Research Immunology/BMT
Los Angeles, California, United States, 90027
University of California San Francisco
San Francisco, California, United States, 94158
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
University of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
Saint Louis University School of Medicine
St Louis, Missouri, United States, 63104
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
UNC Pediatrics/NC Children's Hospital
Chapel Hill, North Carolina, United States, 27599
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104
Seattle Children's Hospital
Seattle, Washington, United States, 98105
West Virginia University Children's Hospital
Morgantown, West Virginia, United States, 26506
John Hunter Children's Hospital (JHCH)
New Lambton Heights, New South Wales, Australia, 2305
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
Berlin, Germany, 13353
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer
Florence, Italy, 50139
Polo Universitario - L'Azienda Ospedaliera Luigi Sacco
Milan, Italy, 20157
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego
Bydgoszcz, Poland, 85-030
Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology
Moscow, Russia, 111123
Federal Government Institution "Republican Clinical Infectious Hospital"
Saint Petersburg, Russia, 196645
Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency
Saint Petersburg, Russia, 197022
Birmingham Childrens Hospital NHS Trust
Birmingham, United Kingdom, B4 6NH
Royal Hospital for Sick Children Glasgow
Glasgow, United Kingdom, G3 8SJ
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