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Clinical trials for Cyanotic heart 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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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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    9 result(s) found for: Cyanotic heart disease. Displaying page 1 of 1.
    EudraCT Number: 2006-000946-38 Sponsor Protocol Number: EFC5314 Start Date*: 2007-01-24
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: International randomized double blind clinical study evaluating the efficacy and safety of clopidogrel 0.2mg/kg once daily versus placebo in neonates and infants with cyanotic congenital heart dise...
    Medical condition: Neonates or infants (age less than or equal to 92 days at the time of randomization) with systemic to pulmonary arterial shunt for palliation of cyanotic congenital heart disease.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019273 Heart disease congenital LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) FI (Completed) SE (Completed) DK (Completed) PT (Completed) FR (Completed) HU (Completed) IT (Completed) NL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-004999-53 Sponsor Protocol Number: LTS10916 Start Date*: 2009-02-06
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: Long-term safety study in patients included in CLARINET study with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt and for whom the shunt is still in place at...
    Medical condition: Patients at one year of age who are included in CLARINET, with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt, and for whom the shunt is still in place.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019273 Heart disease congenital LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) ES (Completed) BE (Completed) DE (Completed) FR (Completed) IT (Completed) GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-000390-31 Sponsor Protocol Number: HyperHAES-PÄD-CARDIO-02 Start Date*: 2007-10-30
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Application of hypertonic hyperoncotic solutions for improvement of cardiac output after open heart surgery in children - monocentric, randomised, placebo controlled, double-blind clinical trial (p...
    Medical condition: Children after open-heart surgery for congenital cardiac disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019273 Heart disease congenital LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019713-21 Sponsor Protocol Number: CS/2007/2678 Start Date*: 2010-06-17
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: A RANDOMISED CONTROLLED TRIAL TO COMPARE NORMOXIC VERSUS STANDARD CARDIOPULMONARY BYPASS IN CYANOTIC CHILDREN UNDERGOING CARDIAC SURGERY
    Medical condition: The study investigates reoxygenation injury in cyanotic paediatric patients undergoing on-pump cardiac surgery. The types of heart condition being investigated result in chronic low blood oxygen sa...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10010395 Congenital cardiac malpositions and transpositions HLT
    12.1 10010397 Congenital cardiac structural defects NEC HLT
    12.1 10010396 Congenital cardiac septal defect NOS LLT
    12.1 10062326 Congenital cardiac septal defect LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-001759-38 Sponsor Protocol Number: K675 Start Date*: 2019-12-04
    Sponsor Name:Ruprecht-Karls University Heidelberg Medical Faculty, University Hospital represented in law by its commercial director
    Full Title: Pharmacokinetics of a microdosed cocktail containing rivaroxaban, apixaban and edoxaban in children with congenital heart defects
    Medical condition: 20 children with non-cyanotic congenital heart defects especially atrial septal defects (ASD) and ventricular septal defects (VSD) in admitted to the paediatric cardiology wards will be included. T...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000221-39 Sponsor Protocol Number: M15-539 Start Date*: 2017-12-14
    Sponsor Name:AbbVie Inc
    Full Title: A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infectio...
    Medical condition: Severe Respiratory Syncytial Virus (RSV) Infection
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-005996-11 Sponsor Protocol Number: MK-1654-007 Start Date*: 2021-08-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for S...
    Medical condition: Prevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10066742 Respiratory syncytial virus infection prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) DE (Trial now transitioned) FI (Trial now transitioned) Outside EU/EEA HU (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004527-42 Sponsor Protocol Number: W10-664 Start Date*: 2015-02-03
    Sponsor Name:Abbott Laboratories LLC
    Full Title: A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis® in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation.
    Medical condition: Severe Respiratory Syncytial Virus Infection (RSV)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-004915-38 Sponsor Protocol Number: V114-017 Start Date*: 2018-10-04
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparatorcontrolled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six M...
    Medical condition: Pneumococcal disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    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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