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NCT03022981 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
NCT03022981: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT03022981 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 216 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03022981, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
Study Summary
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection. The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
Primary Outcome
AUCtau is defined as concentration of drug over time (the area under the concentration versus time curve over the dosing interval).
Interventions
- DRUG SOF/VEL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2017-01-26 |
| Est. Completion | 2020-02-26 |
| Phase | Phase 2 |
What the finished NCT03022981 record still lists
NCT03022981 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 1 intervention - of which SOF/VEL is the first listed.
NCT03022981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03022981 about?
NCT03022981 is a clinical study titled "Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection". This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic he...
What is the current status of trial NCT03022981?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2017-01-26. Estimated completion is 2020-02-26.
What interventions are being tested in trial NCT03022981?
The interventions under investigation include: SOF/VEL (DRUG).
Who is sponsoring clinical trial NCT03022981?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03022981's enrollment target sits among peer trials
216 286th of 2000 higher than 1,712 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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