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Clinical trials for Kawasaki Disease

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    9 result(s) found for: Kawasaki Disease. 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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002783-27 Sponsor Protocol Number: KAWA2019-1962 Start Date*: 2020-03-04
    Sponsor Name:Amsterdam University Medical Center
    Full Title: A 12-month, open-label, parallel-cohort study to evaluate the efficacy, safety and tolerability of Canakinumab in Kawasaki disease
    Medical condition: Active Kawasaki disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10047065 - Vascular disorders 10023320 Kawasaki's disease PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004433-17 Sponsor Protocol Number: 124210 Start Date*: 2020-02-18
    Sponsor Name:MRC CTU at UCL
    Full Title: Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary arte...
    Medical condition: Kawasaki Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10047065 - Vascular disorders 10023320 Kawasaki's disease PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Ongoing) EE (Ongoing) SE (Ongoing) FI (Ongoing) ES (Ongoing) DE (Ongoing) NL (Ongoing) IT (Ongoing) AT (Ongoing) CZ (Ongoing)
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-001841-14 Sponsor Protocol Number: PICOLO Start Date*: 2005-01-10
    Sponsor Name:SANOFI-SYNTHELABO
    Full Title: Dose-ranging pharmacodynamic assessment of platelet aggregation inhibition with clopidogrel in children of Blalock-Taussig shunt age categories (neonates and infants/toddlers)
    Medical condition: neonates or infants/toddlers at risk of thrombosis
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) BE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-002615-25 Sponsor Protocol Number: GE-262-001 Start Date*: 2020-03-27
    Sponsor Name:GE Healthcare Ltd.
    Full Title: An Open-label, Single-dose, Safety and Pharmacokinetic Study of Regadenoson in Paediatric Patients
    Medical condition: Patients who need to undergo a clinically indicated pharmacologic stress perfusion CMR test and who are considered fit for a pharmacological stress perfusion CMR by the investigator. The pharmacolo...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004848 10028603 Myocardial perfusion scan LLT
    20.0 100000004848 10065141 Vascular diagnostic procedure LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Ongoing) IT (Ongoing) GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000475-90 Sponsor Protocol Number: DU176b-C-U313 Start Date*: 2018-03-27
    Sponsor Name:Daiichi Sankyo Inc
    Full Title: AN OPEN-LABEL, RANDOMISED, PARALLEL-GROUP, MULTICENTRE, OBSERVATIONAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF EDOXABAN TOSYLATE IN CHILDREN FROM 38 WEEKS GESTATIONAL AGE TO LESS THAN 18 YEARS OF A...
    Medical condition: thromboembolism
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10043566 Thromboembolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) DE (Completed) ES (Completed) AT (Completed) FR (Completed) PL (Completed) HR (Ongoing) IT (Ongoing)
    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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