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Clinical trials for Craniosynostosis

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   44339   clinical trials with a EudraCT protocol, of which   7369   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: Craniosynostosis. Displaying page 1 of 1.
    EudraCT Number: 2015-000545-22 Sponsor Protocol Number: 2012/462. Start Date*: 2015-08-05
    Sponsor Name:Aarhus University hospital
    Full Title: Effects of Tranexamic Acid on on Intra- and Postoperative bleeding, Blood transfusion and Coagulation in Children Undergoing Craniosynostosis Surgery
    Medical condition: Bleeding during paediatric Craniosynostosis surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10049889 Craniosynostosis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001056-35 Sponsor Protocol Number: TXA Start Date*: 2014-11-24
    Sponsor Name:IRCCS Istituto Giannina Gaslini
    Full Title: The Effectiveness and Population Pharmacokinetics and Pharmacogenomics of a Reduced Dose of Tranexamic Acid for Craniosynostosis Surgery: A multicenter study. The TXA Study.
    Medical condition: craniosynostosis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10049889 Craniosynostosis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-005065-31 Sponsor Protocol Number: 9769 Start Date*: 2017-05-09
    Sponsor Name:University hospital of Montpellier
    Full Title: Comparison of preoperative hemoglobin after administration of epoetin alpha associated with oral martial supplementation vs intraveinous martial supplementation before craniosynostosis in children
    Medical condition: Craniosynostosis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002287-24 Sponsor Protocol Number: 201105-RCTTEG Start Date*: 2012-07-11
    Sponsor Name:Erasmus MC
    Full Title: Massive blood loss in children during multiple trauma or major surgery: Fibrinogen therapy for massive blood loss during elective surgery for craniosynostosis repair, a double blinded randomized c...
    Medical condition: massive blood loss in surgery for premature fusion of cranial sutures, massive blood loss in fused bones of the skull
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004866 10005645 Blood loss of (NOS) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-007406-11 Sponsor Protocol Number: ENB-002-08 Start Date*: 2009-02-25
    Sponsor Name:Enobia Canada Limited Partnership
    Full Title: A Multicenter, Open-Label Study of the Safety, Tolerability and Pharmacology of ENB-0040 (Enobia’s human recombinant tissue non-specific alkaline phosphatase fusion protein) in up to 6 Severely Aff...
    Medical condition: Infantile Hypophosphatasia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10049933 Hypophosphatasia PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-004972-74 Sponsor Protocol Number: 20160227 Start Date*: 2020-09-15
    Sponsor Name:Amgen Inc.
    Full Title: An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
    Medical condition: Osteogenesis imperfecta (OI) is a group of genetic skeletal disorders characterized by increased bone fragility, low bone mass , and increased bone turnover contributing to osteoporosis, fracture...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10031243 Osteogenesis imperfecta PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) GR (Completed) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000184-40 Sponsor Protocol Number: 20130173 Start Date*: 2014-09-11
    Sponsor Name:Amgen, Inc.
    Full Title: Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta
    Medical condition: Osteogenesis Imperfecta
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10031243 Osteogenesis imperfecta PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) ES (Completed) Outside EU/EEA BG (Completed) PL (Prematurely Ended) BE (Completed) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002803-81 Sponsor Protocol Number: TREX Start Date*: 2020-04-03
    Sponsor Name:IRCCS ISTITUTO GIANNINA GASLINI
    Full Title: Neurodevelopmental outcome after standard dose sevoflurane versus low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia in young children
    Medical condition: Children under the age of 2 years having surgery lasting at least 2 hours
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10018060 General anaesthesia PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-019850-42 Sponsor Protocol Number: ENB-010-10 Start Date*: 2011-03-04
    Sponsor Name:Alexion Pharma GmbH
    Full Title: An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase alfa (human recombinant tissue nonspecific alkaline phosphatase fusion protein) in Infants a...
    Medical condition: Hypophosphatasia is a rare inborn error of bone metabolism caused by inactivating mutations in the gene encoding the Tissue-nonspecific alkaline phosphatase isoenzyme. With deficiency of Tissue-...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10049933 Hypophosphatasia PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) IT (Completed) ES (Completed) FR (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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