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NCT02510300
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
trial testing Sofosbuvir (SOF) in Hepatitis C Virus Infection in 461 participants. Terminated before completion.
6 January 2023
Quick facts
| Lead sponsor | Gilead Sciences |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 461 |
| Start date | 21 October 2015 |
| Primary completion | 6 January 2023 |
| Estimated completion | 6 January 2023 |
| Sites | 51 locations across Italy, New Zealand, Russia, Belgium, United Kingdom, Germany, Poland, Australia |
Drugs / interventions tested
- Sofosbuvir (SOF) — full drug profile →
- Ledipasvir/Sofosbuvir (LDV/SOF) — full drug profile →
- Sofosbuvir/Velpatasvir (SOF/VEL) — full drug profile →
- Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)
Conditions studied
- Hepatitis C Virus Infection — all drugs for Hepatitis C Virus Infection →
Sponsor
Gilead Sciences — full company profile →
Who can join
3 and older, any sex, with Hepatitis C Virus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Updated Clinical Guidelines on the Management of Hepatitis C Infection in Children.
Jarasvaraparn C, Hartley C, Karnsakul W. · · 2024 · cited 6× · PMID 38392918 · DOI 10.3390/pathogens13020180 -
Long-term efficacy and safety of sofosbuvir-based direct-acting antiviral regimens in paediatric patients with hepatitis C virus infection: an international registry study.
Gonzalez-Peralta RP, Wen JW, Hardikar W, Karnsakul WW, et al · · 2025 · cited 3× · PMID 40113366 · DOI 10.1016/s2352-4642(25)00028-8 -
[Use of sofosbuvir-based regimens in the treatment of adolescents and children with chronic hepatitis C].
He S, Wang XY, Han QY, Liu ZW. · · 2021 · PMID 33548971 · DOI 10.3760/cma.j.cn501113-20190606-00199
Verify or expand the search:
- PubMed search for NCT02510300
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sofosbuvir (SOF)
Trials testing the same drug.
- NCT02421211 — A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consist · Phase 2 · completed
Other recruiting trials for Hepatitis C Virus Infection
Currently open trials in the same condition.
- NCT06870019 — Hepatitis C Tracker Study · NA · recruiting
- NCT06463912 — Screening for Hepatitis c in People Who Inject Drugs in Armenia-Colombia · recruiting
- NCT06718530 — Characterization of Immune Genotypes and Antibody Profiles to Foster the discoVERY of diagnosticbioMARKERS of Liver Canc · recruiting
- NCT06155006 — Adult Screening for Hepatitis c and Linkage to Treatment in Hospitals in Colombia · recruiting
- NCT06431945 — Early Detection of HCV in Injection Drug Users · recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
- NCT07115368 — Study of GS-1219 in Participants With HIV-1 · Phase 1 · terminated
- NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
- NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain · completed
- NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated · Phase 2, PHASE3 · terminated
- NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02510300 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
- Last refreshed: 27 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02510300.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing