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



Status:Enrolling by invitation
Conditions:Infectious Disease, Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - Any
Updated:3/15/2019
Start Date:October 21, 2015
End Date:September 2027

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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

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.


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.
We found this trial at
27
sites
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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801 Seventh Avenue
Fort Worth, Texas 76104
682-885-7491
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Fort Worth, TX
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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New York, NY
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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130 Mason Farm Road
Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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4650 Sunset Boulevard
Los Angeles, California 90027
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Louisville, Kentucky 40202
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1 Medical Center Drive
Morgantown, West Virginia 26506
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Nashville, TN
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Orlando, FL
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Saint Louis, Missouri 63130
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San Antonio, Texas 78215
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San Francisco, California 94143
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Westmead, New South Wales
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