Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004674-42 | EudraCT Number |
Not provided
Not provided
Not provided
The study stopped early because the study objectives were met.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir (SOF) | Drug | 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 | 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 | 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 | Exposure of interest for participants who received a SOF/VEL/VOX-based regimen in previous Gilead-sponsored chronic hepatitis C infection trials |
| Measure | Description | Time Frame |
|---|---|---|
| Growth data as measured by body height | Up to 5 years | |
| Growth data as measured by body weight | Up to 5 years | |
| Development as measured by Tanner Pubertal Stage Assessment | Up to 5 years |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
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)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Children's Hospital Los Angeles, Div. of Research Immunology/BMT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40113366 | Derived | 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. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
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/
18 months after study completion
A secured external environment with username, password, and RSA code.
Not provided
Not provided
Not provided
Not provided
Blood samples
| Los Angeles |
| California |
| 90027 |
| United States |
| University of California San Francisco | San Francisco | California | 94158 | United States |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of Louisville School of Medicine | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64108 | United States |
| Saint Louis University School of Medicine | St Louis | Missouri | 63104 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| UNC Pediatrics/NC Children's Hospital | Chapel Hill | North Carolina | 27599 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Cook Children's Health Care System | Fort Worth | Texas | 76104 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| West Virginia University Children's Hospital | Morgantown | West Virginia | 26506 | United States |
| John Hunter Children's Hospital (JHCH) | New Lambton Heights | New South Wales | 2305 | Australia |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| The Royal Children's Hospital | Parkville | Victoria | 3052 | Australia |
| Cliniques Universitaires Saint- LUC UCL | Brussels | 1200 | Belgium |
| Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Helios Klinikum Wuppertal | Wuppertal | 42283 | Germany |
| Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia | 71013 | Italy |
| Policlinico Sant'Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliero Universitaria - Ospedale Pediatrico Meyer | Florence | 50139 | Italy |
| Polo Universitario - L'Azienda Ospedaliera Luigi Sacco | Milan | 20157 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| Azienda Ospedaliero-Universitaria di Padova | Padova | 35128 | Italy |
| Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Auckland Clinical Studies | Auckland | 1010 | New Zealand |
| Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza, Klinika Chorób Zakaźnych i Hepatologii Wieku Rozwojowego | Bydgoszcz | 85-030 | Poland |
| MED. POLONIA Sp. z.o.o. | Poznan | 60-693 | Poland |
| Federal Budget Institution of Science-Central Scientific and Research Institute of Epidemiology | Moscow | 111123 | Russia |
| Federal Government Institution "Republican Clinical Infectious Hospital" | Saint Petersburg | 196645 | Russia |
| Scientific-Research Institute of Children's Infections of Federal Medico- Biological Agency | Saint Petersburg | 197022 | Russia |
| Ltd Medical Company "Hepatolog" | Tolyatti | 445009 | Russia |
| Birmingham Childrens Hospital NHS Trust | Birmingham | B4 6NH | United Kingdom |
| Royal Hospital for Sick Children Glasgow | Glasgow | G3 8SJ | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C586541 | ledipasvir |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| C000604171 | velpatasvir |
| C000611331 | sofosbuvir-velpatasvir drug combination |
| C000654129 | sofosbuvir velpatasvir voxilaprevir drug combination |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
Not provided
Not provided