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
Public ClinicalTrials.gov record NCT02510300. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02510300
- Recruitment status
- Terminated
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 461 participants
Conditions and interventions
Conditions
Interventions
- Sofosbuvir (SOF) Drug
- Ledipasvir/Sofosbuvir (LDV/SOF) Drug
- Sofosbuvir/Velpatasvir (SOF/VEL) Drug
- Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Drug
Drug
Eligibility (public fields only)
- Age range
- 3 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 21, 2015 (Actual)
- Primary completion
- Jan 6, 2023 (Actual)
- Completion
- Jan 6, 2023 (Actual)
- Last update posted
- Jan 27, 2023
2015 – 2023
United States locations
- U.S. sites
- 27
- U.S. states
- 20
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Children's Hospital Los Angeles, Div. of Research Immunology/BMT | Los Angeles | California | 90027 | — |
| University of California San Francisco | San Francisco | California | 94158 | — |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Louisville School of Medicine | Louisville | Kentucky | 40202 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64108 | — |
| Saint Louis University School of Medicine | St Louis | Missouri | 63104 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| 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 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | — |
| Cook Children's Health Care System | Fort Worth | Texas | 76104 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| West Virginia University Children's Hospital | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02510300, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2023 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02510300 live on ClinicalTrials.gov.