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NCT02510300 Clinical Trial

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

Hepatitis C Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02510300
Other study ID # GS-US-334-1113
Secondary ID 2014-004674-42
Status Terminated
Phase
First received
Last updated
Start date October 21, 2015
Est. completion date January 6, 2023

Study information
Verified date January 2023
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 461
Est. completion date January 6, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sofosbuvir (SOF)
Exposure of interest for participants who received a SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
• Ledipasvir/Sofosbuvir (LDV/SOF)
Exposure of interest for participants who received a LDV/SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
• Sofosbuvir/Velpatasvir (SOF/VEL)
Exposure of interest for participants who received a SOF/VEL-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials
• Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)
Exposure of interest for participants who received a SOF/VEL/VOX-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

Locations
Country Name City State
Australia John Hunter Children's Hospital (JHCH) New Lambton Heights New South Wales
Australia The Royal Children's Hospital Parkville Victoria
Australia The Children's Hospital at Westmead Westmead New South Wales
Belgium Cliniques Universitaires Saint- LUC UCL Brussels
Germany Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum Berlin
Germany Helios Klinikum Wuppertal Wuppertal
Italy Policlinico Sant'Orsola Malpighi Bologna
Italy Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer Firenze
Italy Polo Universitario - L'Azienda Ospedaliera Luigi Sacco Milano
Italy Azienda Ospedaliera Universitaria Federico II Napoli
Italy Azienda Ospedaliero-Universitaria di Padova Padova
Italy Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Foggia
Italy Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino Torino
New Zealand Auckland Clinical Studies Auckland
Poland Wojewódzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza, Klinika Chorób Zakaznych i Hepatologii Wieku Rozwojowego Bydgoszcz
Poland MED. POLONIA Sp. z.o.o. Poznan
Russian Federation Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology Moscow
Russian Federation Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency Saint Petersburg
Russian Federation Federal Government Institution "Republican Clinical Infectious Hospital" Saint-Petersburg
Russian Federation Ltd Medical Company "Hepatolog" Tolyatti
United Kingdom Birmingham Childrens Hospital NHS Trust Birmingham
United Kingdom Royal Hospital for Sick Children Glasgow Glasgow
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom King's College Hospital London
United States Children's Healthcare of Atlanta at Egleston Atlanta Georgia
United States Children's Hospital of Colorado Aurora Colorado
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States Boston Children's Hospital Boston Massachusetts
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 Children's Medical Center Dallas Dallas Texas
United States Cook Children's Health Care System Fort Worth Texas
United States University of Florida Gainesville Florida
United States Texas Children's Hospital Houston Texas
United States Riley Hospital for Children Indianapolis Indiana
United States Children's Mercy Hospital and Clinics Kansas City Missouri
United States Children's Hospital Los Angeles, Div. of Research Immunology/BMT Los Angeles California
United States University of Louisville School of Medicine Louisville Kentucky
United States West Virginia University Children's Hospital Morgantown West Virginia
United States Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville Tennessee
United States Mount Sinai Medical Center New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States AdventHealth Orlando Orlando Florida
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States Saint Louis University School of Medicine Saint Louis Missouri
United States Texas Liver Institute San Antonio Texas
United States University of California San Francisco San Francisco California
United States Seattle Children's Hospital Seattle Washington
United States Children's National Medical Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Germany,  Italy,  New Zealand,  Poland,  Russian Federation,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Growth data as measured by body height Up to 5 years
Primary Growth data as measured by body weight Up to 5 years
Primary Development as measured by Tanner Pubertal Stage Assessment Up to 5 years
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