Clinical trial NCT02510300: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-07-29
Enrollment: 461
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who 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 (DAA)

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.


Eligibility criteria: Key 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

Key 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.

Primary outcomes:
measure: Growth data as measured by body height
timeFrame: Up to 5 years
measure: Growth data as measured by body weight
timeFrame: Up to 5 years
measure: Development as measured by Tanner Pubertal Stage Assessment
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles, Div. of Research Immunology/BMT
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Louisville
country: United States
facility: University of Louisville School of Medicine
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital and Clinics
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Pediatrics/NC Children's Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Health Care System
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Children's Hospital
state: West Virginia
city: New Lambton Heights
country: Australia
facility: John Hunter Children's Hospital (JHCH)
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Parkville
country: Australia
facility: The Royal Children's Hospital
state: Victoria
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint- LUC UCL
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer
city: Milano
country: Italy
facility: Polo Universitario - L'Azienda Ospedaliera Luigi Sacco
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Padova
country: Italy
facility: Azienda Ospedaliero-Universitaria di Padova
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
city: Bydgoszcz
country: Poland
facility: Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego
city: Poznan
country: Poland
facility: MED. POLONIA Sp. z.o.o.
city: Moscow
country: Russian Federation
facility: Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology
city: Saint Petersburg
country: Russian Federation
facility: Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency
city: Saint-Petersburg
country: Russian Federation
facility: Federal Government Institution "Republican Clinical Infectious Hospital"
city: Tolyatti
country: Russian Federation
facility: Ltd Medical Company "Hepatolog"
city: Birmingham
country: United Kingdom
facility: Birmingham Childrens Hospital NHS Trust
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children Glasgow
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: