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NCT03330457 · ClinicalTrials.gov registry record · Phase 2
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing
A Phase 2 study, sponsored by Portola Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT03330457: Clinical Trial Phase 2 study, sponsored by Portola Pharmaceuticals.
NCT03330457 is a Phase 2 study that was terminated before completion, run by Portola Pharmaceuticals. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03330457, a Phase 2 study, was terminated before completion, sponsored by Portola Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, single center study in healthy volunteers dosed to steady state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and tolerability of andexanet vs. placebo (3) Determine the PK properties of andexanet and betrixaban (4) Determine the PD properties of betrixaban before, during, and after receiving andexanet or placebo and (5) Investigate the immunogenicity of andexanet in the presence of betrixaban.
Primary Outcome
Change in Anti-Fxa Activity from baseline to end of bolus
Interventions
- BIOLOGICAL Andexanet alfa (bolus)
- DRUG Betrixaban 80 mg PO QD
- BIOLOGICAL Andexanet alfa (infusion IV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-08-06 |
| Est. Completion | 2016-02-22 |
| Phase | Phase 2 |
Why NCT03330457 stopped before completion
NCT03330457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Andexanet alfa (bolus) is the first listed.
NCT03330457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03330457 about?
NCT03330457 is a clinical study titled "A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing". This is a randomized, double-blind, single center study in healthy volunteers dosed to steady state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and tolerability of andexanet...
What is the current status of trial NCT03330457?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2015-08-06. Estimated completion is 2016-02-22.
What interventions are being tested in trial NCT03330457?
The interventions under investigation include: Andexanet alfa (bolus) (BIOLOGICAL), Betrixaban 80 mg PO QD (DRUG), Andexanet alfa (infusion IV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03330457?
This trial is sponsored by Portola Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03330457's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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