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Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor XA Inhibitor Who Have Acute Major Bleeding (Annexa-4), Amendment 6 - Annexa-4

Trial Profile

Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor XA Inhibitor Who Have Acute Major Bleeding (Annexa-4), Amendment 6 - Annexa-4

Status: Completed
Phase of Trial: Phase III/IV

Latest Information Update: 03 Nov 2023

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At a glance

  • Drugs Andexanet alfa (Primary)
  • Indications Gastrointestinal haemorrhage; Haemorrhage; Intracranial haemorrhages
  • Focus Registrational; Therapeutic Use
  • Acronyms ANNEXA-4
  • Sponsors Alexion AstraZeneca Rare Disease
  • Most Recent Events

    • 20 Feb 2023 Results of final analysis published in the Circulation
    • 10 Feb 2023 Results(n=305) assessing Intracranial Hemorrhage Volume Expansion In Patients Receiving Factor Xa Inhibitors In The Annexa-4 Trial presented at the International Stroke Conference 2023
    • 29 Mar 2022 According to a AstraZeneca media release, Ondexxya (andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from this trial.
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