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Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery

NCT04233073 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-22

Study results available
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Summary

Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.

Conditions

  • Surgery

Interventions

DRUG

andexanet alfa

Andexanet is a recombinant version of human FXa

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-27
Primary Completion
2021-11-23
Completion
2022-01-25
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Israel
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233073 on ClinicalTrials.gov