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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 is a Phase 3 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 479 participants.

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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.

Interventions

  • BIOLOGICAL Andexanet

Trial Details

FieldValue
Enrollment Target 479 participants
Start Date 2015-04-10
Est. Completion 2020-09-24
Phase Phase 3

Sponsor

Alexion Pharmaceuticals

162 total trials

What the Registry Record Tells You About NCT02329327

The ClinicalTrials.gov registry entry for NCT02329327 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 479 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Andexanet is the first listed.

NCT02329327 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.