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Clinical trials for Idarucizumab

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    2 result(s) found for: Idarucizumab. Displaying page 1 of 1.
    EudraCT Number: 2015-002177-37 Sponsor Protocol Number: 1321.7 Start Date*: 2016-06-01
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilat...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10066899 Venous thromboembolism LLT
    18.1 100000004865 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) LT (Completed) CZ (Completed) IT (Completed) DE (Completed) Outside EU/EEA GR (Completed) HU (Completed) BE (Completed) ES (Prematurely Ended) BG (Completed) AT (Completed) FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-004813-41 Sponsor Protocol Number: 1321.3 Start Date*: 2014-05-26
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Phase III case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated wtih dabigatran ...
    Medical condition: Hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10019524 Hemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IE (Completed) PT (Completed) SE (Completed) ES (Completed) FI (Completed) EE (Completed) LV (Prematurely Ended) CZ (Completed) IT (Completed) SK (Completed) NL (Completed) BE (Completed) AT (Completed) NO (Completed) DK (Completed) FR (Completed)
    Trial results: View results
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    Query did not match any studies.
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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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