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Clinical trials for Andexanet alfa

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    3 result(s) found for: Andexanet alfa. Displaying page 1 of 1.
    EudraCT Number: 2015-001785-26 Sponsor Protocol Number: 14-505 Start Date*: 2016-02-15
    Sponsor Name:Portola Pharmaceuticals, Inc.
    Full Title: Prospective, Open-label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor who Have Acute Major Bleeding (ANNEXA-4).
    Medical condition: Uncontrolled bleeding in patients who have taken either a direct factor Xa inhibitor (novel oral anticoagulants) or an indirect factor Xa inhibitor (low molecular weight heparins).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000022097 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed) BE (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-000374-21 Sponsor Protocol Number: 19-515 Start Date*: 2020-08-17
    Sponsor Name:Alexion Pharmaceuticals, Inc
    Full Title: PROSPECTIVE, OPEN-LABEL STUDY OF ANDEXANET ALFA IN PATIENTS RECEIVING A FACTOR XA INHIBITOR WHO REQUIRE URGENT SURGERY (ANNEXA-S)
    Medical condition: Need for FXa inhibitor reversal in patients undergoing urgent surgery.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002620-17 Sponsor Protocol Number: 18-513 Start Date*: 2019-01-08
    Sponsor Name:Portola Pharmaceuticals, Inc
    Full Title: A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR
    Medical condition: Oral FXa inhibitor-treated patients with acute intracranial bleeding.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10075279 Anticoagulant reversal therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) BE (Completed) NL (Completed) ES (Prematurely Ended) GR (Completed) CZ (Completed) LV (Completed) FI (Prematurely Ended) NO (Prematurely Ended) LT (Prematurely Ended) PL (Completed) PT (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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