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 |
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.
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
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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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
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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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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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
Los Angeles, California 90027
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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111 Michigan Ave NW
Washington, District of Columbia
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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