MedTrace Logo

Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya

NCT05898412 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 217

Last updated 2026-04-17

No results posted yet for this study

Summary

This is an observational retrospective database study of hospitalized patients treated with andexanet alfa in approximately 10 Dutch hospitals. Currently there is limited information on the patient characteristics and outcomes of patients who are treated with andexanet alfa in The Netherlands and how it is used. This is of interest for treating clinicians because there is a need for a patient profile, also due to the on par position of andexanet alfa with PCC in the Dutch national guideline.

Analysis of the data showed that 14 patients of the 218 patients included in the study (6.4%) experienced a thrombotic event (TE) within 30 days after treatment with andexanet alfa. The protocol was amended to allow for an in depth analysis of the 14 TE cases.

Conditions

Interventions

DRUG

Andexanet alfa

Patients treated with andexanet alfa

Sponsors & Collaborators

  • LOGEX Healthcare Analytics Amsterdam The Netherlands

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-06
Primary Completion
2025-11-25
Completion
2025-11-25

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
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 NCT05898412 on ClinicalTrials.gov