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Clinical trials for Kawasaki syndrome

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   44366   clinical trials with a EudraCT protocol, of which   7389   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    4 result(s) found for: Kawasaki syndrome. Displaying page 1 of 1.
    EudraCT Number: 2015-003763-11 Sponsor Protocol Number: CACZ885D2208 Start Date*: 2016-06-15
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 12-week, open-label, parallel-cohort study to evaluate the efficacy, safety and tolerability of canakinumab in pediatric IVIG-naïve or refractory patients with active Kawasaki disease
    Medical condition: Active Kawasaki disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 10047065 - Vascular disorders 10023320 Kawasaki's disease PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) BE (Completed) DE (Prematurely Ended) NL (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-002715-41 Sponsor Protocol Number: P130934 Start Date*: 2015-08-11
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: KAWAKINRA study, "A phase IIa multicenter trial to assess the efficacy and safety of Anakinra in patients with intraveinous immunoglobulin-resistant Kawasaki disease"
    Medical condition: Anakinra treatment is expected to reduce the early and long term mortality of patients with Kawasaki Disease (KD), by a rapid and sustained effect on vascular inflammation
    Disease: Version SOC Term Classification Code Term Level
    17.1 10047065 - Vascular disorders 10023320 Kawasaki's disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001247-39 Sponsor Protocol Number: CV185-362 Start Date*: 2017-04-24
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart ...
    Medical condition: Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019273 Heart disease congenital PT
    20.0 10007541 - Cardiac disorders 10007636 Cardiomyopathy PT
    20.0 10007541 - Cardiac disorders 10019276 Heart disease, unspecified LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    20.0 10047065 - Vascular disorders 10023320 Kawasaki's disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) FI (Completed) AT (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003194-22 Sponsor Protocol Number: APHP200009 Start Date*: Information not available in EudraCT
    Sponsor Name:Assistance Publique – Hôpitaux de Paris (AP-HP)
    Full Title: A RANDOMIZED PHASE III MULTICENTER TRIAL COMPARING THE EFFICACY AND SAFETY OF ANAKINRA VERSUS INTRAVENOUS IMMUNOGLOBULIN (IVIG) RETREATMENT, IN PATIENTS WITH KAWASAKI DISEASE WHO FAILED TO RESPOND ...
    Medical condition: Anakinra treatment is expected to reduce the early and long-term mortality of patients with Kawasaki Disease (KD), by a rapid and sustained effect on vascular inflammation.
    Disease:
    Population Age: Infants and toddlers, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
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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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