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NCT03346083 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Betrixaban in Pediatric Participants
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03346083: Clinical Trial Phase 1 study, sponsored by Alexion Pharmaceuticals.
NCT03346083 is a Phase 1 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03346083, a Phase 1 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This trial was a Phase 1, open-label, multicenter study of the pharmacokinetics (PK), pharmacodynamics (PD), and safety of a single dose of betrixaban in pediatric participants at risk of venous thromboembolism (VTE).
Primary Outcome
Following the Sponsor's decision to cease developing betrixaban, data for AUC(0-inf) were not collected.
Interventions
- DRUG Betrixaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2019-10-08 |
| Phase | Phase 1 |
Why NCT03346083 stopped before completion
NCT03346083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Betrixaban is the first listed.
NCT03346083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03346083 about?
NCT03346083 is a clinical study titled "Study Evaluating Betrixaban in Pediatric Participants". This trial was a Phase 1, open-label, multicenter study of the pharmacokinetics (PK), pharmacodynamics (PD), and safety of a single dose of betrixaban in pediatric participants at risk of venous thromboembolism (VTE).
What is the current status of trial NCT03346083?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-07-13. Estimated completion is 2019-10-08.
What interventions are being tested in trial NCT03346083?
The interventions under investigation include: Betrixaban (DRUG).
Who is sponsoring clinical trial NCT03346083?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03346083's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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