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
Stopped early
Conditions studied: Hepatitis C Virus Infection
In brief
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.
Key facts
- Study ID
- NCT02510300
- Run by
- Gilead Sciences
- People needed
- 461
- Starts
- 2015-10-21
- Expected to finish
- 2023-01-06
- Last updated by the study team
- 2023-01-27
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Phoenix Children's Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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