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
- Conditions
- Hepatitis C Virus Infection
- Registration Number
- NCT02510300
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 461
- 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
Key
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Children's Hospital Los Angeles, Div. of Research Immunology/BMT
🇺🇸Los Angeles, California, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency
🇷🇺Saint Petersburg, Russian Federation
Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Children's Healthcare of Atlanta at Egleston
🇺🇸Atlanta, Georgia, United States
Saint Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer
🇮🇹Firenze, Italy
Ltd Medical Company "Hepatolog"
🇷🇺Tolyatti, Russian Federation
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
West Virginia University Children's Hospital
🇺🇸Morgantown, West Virginia, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Cook Children's Health Care System
🇺🇸Fort Worth, Texas, United States
Cliniques Universitaires Saint- LUC UCL
🇧🇪Brussels, Belgium
Helios Klinikum Wuppertal
🇩🇪Wuppertal, Germany
Polo Universitario - L'Azienda Ospedaliera Luigi Sacco
🇮🇹Milano, Italy
Azienda Ospedaliero-Universitaria di Padova
🇮🇹Padova, Italy
Auckland Clinical Studies
🇳🇿Auckland, New Zealand
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego
🇵🇱Bydgoszcz, Poland
The Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
MED. POLONIA Sp. z.o.o.
🇵🇱Poznan, Poland
Policlinico Sant'Orsola Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Birmingham Childrens Hospital NHS Trust
🇬🇧Birmingham, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
John Hunter Children's Hospital (JHCH)
🇦🇺New Lambton Heights, New South Wales, Australia
Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology
🇷🇺Moscow, Russian Federation
Federal Government Institution "Republican Clinical Infectious Hospital"
🇷🇺Saint-Petersburg, Russian Federation
Royal Hospital for Sick Children Glasgow
🇬🇧Glasgow, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
University of California San Francisco
🇺🇸San Francisco, California, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Children's Hospital of Colorado
🇺🇸Aurora, Colorado, United States
UNC Pediatrics/NC Children's Hospital
🇺🇸Chapel Hill, North Carolina, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
University of Florida
🇺🇸Gainesville, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Children's Mercy Hospital and Clinics
🇺🇸Kansas City, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States