Study Details

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.

Participation Requirements

Age

3 Years +

Sex

ALL

Healthy Volunteers

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)

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

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, District of Columbia, United States, 20010

University of Florida

Gainesville, Florida, United States, 32610

AdventHealth Orlando

Orlando, Florida, United States, 32803

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

Saint Louis, Missouri, United States, 63104

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Mount Sinai Medical Center

New York, New York, United States, 10029

UNC Pediatrics/NC Children's Hospital

Chapel Hill, North Carolina, United States, 27599

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

Children's Medical Center Dallas

Dallas, Texas, United States, 75235

Cook Children's Health Care System

Fort Worth, Texas, United States, 76104

Texas Children's Hospital

Houston, Texas, United States, 77030

Texas Liver Institute

San Antonio, Texas, United States, 78215

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

The Royal Children's Hospital

Parkville, Victoria, Australia, 3052

Cliniques Universitaires Saint- LUC UCL

Brussels, Belgium, 1200

Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum

Berlin, Germany, 13353

Helios Klinikum Wuppertal

Wuppertal, Germany, 42283

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy, 71013

Policlinico Sant'Orsola Malpighi

Bologna, Italy, 40138

Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer

Firenze, Italy, 50139

Polo Universitario - L'Azienda Ospedaliera Luigi Sacco

Milano, Italy, 20157

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy, 80131

Azienda Ospedaliero-Universitaria di Padova

Padova, Italy, 35128

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy, 10126

Auckland Clinical Studies

Auckland, New Zealand, 1010

Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego

Bydgoszcz, Poland, 85-030

MED. POLONIA Sp. z.o.o.

Poznan, Poland, 60-693

Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology

Moscow, Russian Federation, 111123

Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency

Saint Petersburg, Russian Federation, 197022

Federal Government Institution "Republican Clinical Infectious Hospital"

Saint-Petersburg, Russian Federation, 196645

Ltd Medical Company "Hepatolog"

Tolyatti, Russian Federation, 445009

Birmingham Childrens Hospital NHS Trust

Birmingham, United Kingdom, B4 6NH

Royal Hospital for Sick Children Glasgow

Glasgow, United Kingdom, G3 8SJ

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom, LS9 7TF

King's College Hospital

London, United Kingdom, SE5 9RS

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

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