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NCT02510300 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Gilead Sciences.
- Terminated
- Registry status
- 461
- Enrollment target
NCT02510300: Clinical Trial study, sponsored by Gilead Sciences.
NCT02510300 is a clinical trial that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 461 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02510300 was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- 461 participants
- Enrollment target
Study 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. 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.
Interventions
- DRUG Sofosbuvir/Velpatasvir (SOF/VEL)
- DRUG Sofosbuvir (SOF)
- DRUG Ledipasvir/Sofosbuvir (LDV/SOF)
- DRUG Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 461 participants |
| Start Date | 2015-10-21 |
| Est. Completion | 2023-01-06 |
Why NCT02510300 stopped before completion
NCT02510300 is an observational study that tracks outcomes without assigning an intervention. The registered 461 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which Sofosbuvir/Velpatasvir (SOF/VEL) is the first listed.
NCT02510300 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02510300 about?
NCT02510300 is a clinical study titled "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". 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 sa...
What is the current status of trial NCT02510300?
This trial is currently terminated. The enrollment target is 461 participants. The study started on 2015-10-21. Estimated completion is 2023-01-06.
What interventions are being tested in trial NCT02510300?
The interventions under investigation include: Sofosbuvir/Velpatasvir (SOF/VEL) (DRUG), Sofosbuvir (SOF) (DRUG), Ledipasvir/Sofosbuvir (LDV/SOF) (DRUG), Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) (DRUG).
Who is sponsoring clinical trial NCT02510300?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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