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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 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 216 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03022981
The ClinicalTrials.gov registry entry for NCT03022981 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SOF/VEL is the first listed.
NCT03022981 reports 0 study locations.
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.
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