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NCT03661528 · ClinicalTrials.gov registry record · Phase 4

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

A Phase 4 study, sponsored by Alexion Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
530
Enrollment target

NCT03661528 is a Phase 4 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 530 participants.

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The verdict

NCT03661528, a Phase 4 study, has completed, sponsored by Alexion Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
530 participants
Enrollment target

Study Summary

Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant

Interventions

  • DRUG Usual Care
  • DRUG andexanet alfa

Trial Details

FieldValue
Enrollment Target 530 participants
Start Date 2019-06-06
Est. Completion 2023-08-09
Phase Phase 4

Sponsor

Alexion Pharmaceuticals

162 total trials

What the Registry Record Tells You About NCT03661528

The ClinicalTrials.gov registry entry for NCT03661528 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 530 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 2 interventions - of which Usual Care is the first listed.

NCT03661528 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03661528 about?

NCT03661528 is a clinical study titled "Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor". Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant

What is the current status of trial NCT03661528?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 530 participants. The study started on 2019-06-06. Estimated completion is 2023-08-09.

What interventions are being tested in trial NCT03661528?

The interventions under investigation include: Usual Care (DRUG), andexanet alfa (DRUG).

Who is sponsoring clinical trial NCT03661528?

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.