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Clinical trials for Biliary atresia

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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    8 result(s) found for: Biliary atresia. Displaying page 1 of 1.
    EudraCT Number: 2014-004693-42 Sponsor Protocol Number: 747-206 Start Date*: 2015-06-29
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: A Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia
    Medical condition: Biliary atresia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10004653 Biliary atresia LLT
    20.1 100000004850 10004654 Biliary atresia, congenital LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended) NL (Prematurely Ended) BE (Prematurely Ended) FI (Prematurely Ended) FR (Prematurely Ended) PL (Prematurely Ended) ES (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003807-37 Sponsor Protocol Number: A4250-011 Start Date*: 2020-07-29
    Sponsor Name:Albireo AB
    Full Title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD)
    Medical condition: Biliary Atresia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10004653 Biliary atresia LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) DE (Ongoing) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000974-22 Sponsor Protocol Number: MRX-701 Start Date*: 2021-01-29
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Biliary Atresia after Hepatoportoenterostomy
    Medical condition: Biliary atresia (BA) is a rare, inflammatory condition of the biliary tree that presents in the first weeks of life and leads to bile duct obstruction and consequent liver injury, fibrosis and cirr...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10004653 Biliary atresia LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) PL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-014886-21 Sponsor Protocol Number: BA_BICG_UMCG_1 Start Date*: 2010-01-26
    Sponsor Name:University Medical Centre Groningen
    Full Title: Intraoperative bile duct visualisation in children with biliary atresia using a fluorescence camera system: a pilot study
    Medical condition: Biliary atresia
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002755-42 Sponsor Protocol Number: MRX-800 Start Date*: 2020-03-16
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Partic...
    Medical condition: Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease including, but not limited to, Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Choles...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    20.0 10010331 - Congenital, familial and genetic disorders 10004653 Biliary atresia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) PL (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-001157-32 Sponsor Protocol Number: A4250-003 Start Date*: 2015-05-13
    Sponsor Name:Albireo AB
    Full Title: An exploratory Phase II Study to demonstrate the Safety and Efficacy of A4250 in Children with Cholestatic Pruritus
    Medical condition: Patients wih Cholestatic Pruritus
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-000633-39 Sponsor Protocol Number: FEC-TH Start Date*: 2012-05-21
    Sponsor Name:Fundación para la Formación e Investigación Sanitaria
    Full Title: Extracorporeal photopheresis in liver transplantation. Clinical trial phase I/II safety and efficacy in patients with progressive withdrawal of immunosuppression.
    Medical condition: Liver transplantation more than 2 years of evolution to complications of immunosuppression.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002822-21 Sponsor Protocol Number: ARCHIE001 Start Date*: 2013-10-10
    Sponsor Name:University of Oxford
    Full Title: The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (ARCHIE): a double-blind randomised placebo-controlled trial
    Medical condition: Influenza or influenza-like illness
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (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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