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NCT02329327 · ClinicalTrials.gov registry record · Phase 3
A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
A Phase 3 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 479
- Enrollment target
NCT02329327: Completed Phase 3 study, sponsored by Alexion Pharmaceuticals.
NCT02329327 is a Phase 3 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 479 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02329327, a Phase 3 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 479 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.
Primary Outcome
Anti-fXa activity was measured to assess the ability of andexanet to reverse the anticoagulant effect of FXa inhibitors. Baseline was defined as the last value obtained prior to the start of the andexanet bolus. The change from baseline was calculated as the reduction in anti-fXa activity from baseline to the on-treatment nadir (that is, the minimum value between end of bolus and end of infusion). Percent reduction was calculated as the ratio between the maximum change from baseline and the base
Interventions
- BIOLOGICAL Andexanet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2015-04-10 |
| Est. Completion | 2020-09-24 |
| Phase | Phase 3 |
What the finished NCT02329327 record still lists
NCT02329327 is an interventional study that assigns participants to a tested intervention. The registered 479 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Andexanet is the first listed.
NCT02329327 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02329327 about?
NCT02329327 is a clinical study titled "A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)". The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.
What is the current status of trial NCT02329327?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 479 participants. The study started on 2015-04-10. Estimated completion is 2020-09-24.
What interventions are being tested in trial NCT02329327?
The interventions under investigation include: Andexanet (BIOLOGICAL).
Who is sponsoring clinical trial NCT02329327?
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 NCT02329327's enrollment target sits among peer trials
479 804th of 2000 higher than 1,196 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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