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A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

NCT05926349 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-10-26

No results posted yet for this study

Summary

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

Conditions

  • Urgent Surgery

Interventions

DRUG

Andexanet alfa

Andexanet is a recombinant version of human FXa

DRUG

Usual Care

As per the label of the chosen usual care product(s) and/or usual care standards.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2027-01-05
Completion
2027-09-07
FDA Drug
Yes

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Entities

Companies

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 NCT05926349 on ClinicalTrials.gov