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Hepatitis C Virus InfectionNCT02510300

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

An observational study of Hepatitis C Virus Infection, run by Gilead Sciences at 51 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 3 years and older
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
Sofosbuvir (SOF), Ledipasvir/Sofosbuvir (LDV/SOF) and Sofosbuvir/Velpatasvir (SOF/VEL)
How many people
461 participants
Where
51 sitesin 9 countries
Study dates
21 Oct 2015to 6 Jan 2023
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

51 sites in 9 countries.

51 sites in 9 countries

United States27 sites

  • Children's Healthcare of Atlanta at Egleston

    Atlanta, Georgia, 30322

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • UNC Pediatrics/NC Children's Hospital

    Chapel Hill, North Carolina, 27599

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Children's Medical Center Dallas

    Dallas, Texas, 75235

  • Cook Children's Health Care System

    Fort Worth, Texas, 76104

  • University of Florida

    Gainesville, Florida, 32610

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Children's Mercy Hospital and Clinics

    Kansas City, Missouri, 64108

  • Children's Hospital Los Angeles, Div. of Research Immunology/BMT

    Los Angeles, California, 90027

  • University of Louisville School of Medicine

    Louisville, Kentucky, 40202

  • West Virginia University Children's Hospital

    Morgantown, West Virginia, 26506

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    Nashville, Tennessee, 37232

  • Mount Sinai Medical Center

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • Texas Liver Institute

    San Antonio, Texas, 78215

  • University of California San Francisco

    San Francisco, California, 94158

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Saint Louis University School of Medicine

    St Louis, Missouri, 63104

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Italy7 sites

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer

    Florence, 50139

  • Polo Universitario - L'Azienda Ospedaliera Luigi Sacco

    Milan, 20157

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Ospedaliero-Universitaria di Padova

    Padova, 35128

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

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

    Torino, 10126

Other trials in Italy

Russia4 sites

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

    Moscow, 111123

  • Federal Government Institution "Republican Clinical Infectious Hospital"

    Saint Petersburg, 196645

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

    Saint Petersburg, 197022

  • Ltd Medical Company "Hepatolog"

    Tolyatti, 445009

Other trials in Russia

United Kingdom4 sites

  • Birmingham Childrens Hospital NHS Trust

    Birmingham, B4 6NH

  • Royal Hospital for Sick Children Glasgow

    Glasgow, G3 8SJ

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • King's College Hospital

    London, SE5 9RS

Other trials in United Kingdom

Australia3 sites

  • John Hunter Children's Hospital (JHCH)

    New Lambton Heights, New South Wales, 2305

  • The Royal Children's Hospital

    Parkville, Victoria, 3052

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Germany2 sites

  • Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum

    Berlin, 13353

  • Helios Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

Poland2 sites

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

    Bydgoszcz, 85-030

  • MED. POLONIA Sp. z.o.o.

    Poznan, 60-693

Other trials in Poland

Belgium1 site

  • Cliniques Universitaires Saint- LUC UCL

    Brussels, 1200

Other trials in Belgium

New Zealand1 site

  • Auckland Clinical Studies

    Auckland, 1010

Other trials in New Zealand

About this study

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

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.

Being tested
Sofosbuvir (SOF), Ledipasvir/Sofosbuvir (LDV/SOF), Sofosbuvir/Velpatasvir (SOF/VEL), Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sofosbuvir (SOF)Drug

    Also called Sovaldi®, GS-7977, PSI-7977

    Exposure of interest for participants who received a SOF-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

  • Ledipasvir/Sofosbuvir (LDV/SOF)Drug

    Also called Harvoni®, GS-5885/GS-7977

    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)Drug

    Also called Epclusa®, GS-7977/GS-5816

    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)Drug

    Also called Vosevi®, GS-7977/GS-5816/GS-9857

    Exposure of interest for participants who received a SOF/VEL/VOX-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Growth data as measured by body height

    Measured: Up to 5 years

  2. Growth data as measured by body weight

    Measured: Up to 5 years

  3. Development as measured by Tanner Pubertal Stage Assessment

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2015 (estimated)
  2. Study start21 Oct 2015
  3. Primary completion6 Jan 2023
  4. Study completion6 Jan 2023

Why it stopped: The study stopped early because the study objectives were met.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
461 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02510300
Sponsor's protocol ID
GS-US-334-1113
Other IDs
2014-004674-42, 2014
Status last verified
Jan 2023
First submitted
27 Jul 2015
Last updated
27 Jan 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

Publications

  • Gonzalez-Peralta RP, Wen JW, Hardikar W, Karnsakul WW, Whitworth S, Lin CH, Indolfi G, Rosenthal P, Balistreri W, Schwarz KB, Honegger JR, Zhang X, Svarovskaia EC, Suri V, Kersey K, Leung DH. Long-term efficacy and safety of sofosbuvir-based direct-acting antiviral regimens in paediatric patients with hepatitis C virus infection: an international registry study. Lancet Child Adolesc Health. 2025 Apr;9(4):248-254. doi: 10.1016/S2352-4642(25)00028-8.

    PubMed 40113366

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C Virus Infection, run by Gilead Sciences at 51 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Italy, Russia, United Kingdom, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study stopped early because the study objectives were met.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Growth data as measured by body height (time frame: Up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02510300, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.

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