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

January 25, 2023 updated by: Gilead Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
461

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • John Hunter Children's Hospital (JHCH)
      • Westmead, New South Wales, Australia, 2145
        • The Children's Hospital at Westmead
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • The Royal Children's Hospital
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint- LUC UCL
  • Germany
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
      • Wuppertal, Germany, 42283
        • Helios Klinikum Wuppertal
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sant'Orsola Malpighi
      • Firenze, Italy, 50139
        • Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer
      • Milano, Italy, 20157
        • Polo Universitario - L'Azienda Ospedaliera Luigi Sacco
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Padova, Italy, 35128
        • Azienda Ospedaliero-Universitaria di Padova
      • Torino, Italy, 10126
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Ospedale Casa Sollievo della Sofferenza
  • New Zealand
      • Auckland, New Zealand, 1010
        • Auckland Clinical Studies
  • Poland
      • Bydgoszcz, Poland, 85-030
        • Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego
      • Poznan, Poland, 60-693
        • MED. POLONIA Sp. z.o.o.
  • Russian Federation
      • Moscow, Russian Federation, 111123
        • Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology
      • Saint Petersburg, Russian Federation, 197022
        • Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency
      • Saint-Petersburg, Russian Federation, 196645
        • Federal Government Institution "Republican Clinical Infectious Hospital"
      • Tolyatti, Russian Federation, 445009
        • Ltd Medical Company "Hepatolog"
  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Birmingham Childrens Hospital NHS Trust
      • Glasgow, United Kingdom, G3 8SJ
        • Royal Hospital for Sick Children Glasgow
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles, Div. of Research Immunology/BMT
      • San Francisco, California, United States, 94158
        • University of California San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital of Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta at Egleston
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School Of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital and Clinics
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Pediatrics/NC Children's Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Monroe Carell Jr. Children's Hospital at Vanderbilt
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center Dallas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Health Care System
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • San Antonio, Texas, United States, 78215
        • Texas Liver Institute
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Growth data as measured by body height
Time Frame: Up to 5 years
Up to 5 years
Growth data as measured by body weight
Time Frame: Up to 5 years
Up to 5 years
Development as measured by Tanner Pubertal Stage Assessment
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-334-1113
  • 2014-004674-42 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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/

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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