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Clinical trials for Neonatal cholestasis

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   44344   clinical trials with a EudraCT protocol, of which   7373   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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    17 result(s) found for: Neonatal cholestasis. Displaying page 1 of 1.
    EudraCT Number: 2011-005456-33 Sponsor Protocol Number: Start Date*: 2012-01-26
    Sponsor Name:Med. Univ. Wien, Universitätsklinik für Kinder- und Jugendheilkunde
    Full Title: PREVENTING CHOLESTASIS IN PREMATURE INFANTS USING SMOFLIPID
    Medical condition: • To compare a mixed parenteral lipid emulsion containing fish oil (SMOFlipid®) with a soybean oil based lipid emulsion (Intralipid®) for its effect on the occurrence of parenteral nutrition associ...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004478-41 Sponsor Protocol Number: LCC001 Start Date*: 2015-03-10
    Sponsor Name:King's College London [...]
    1. King's College London
    2. Guy's and St Thomas' NHS Foundation Trust
    Full Title: Phase III trial in IntrahepaTic CHolestasis of pregnancy (ICP) to Evaluate urSodeoxycholic acid (UDCA) in improving perinatal outcomes
    Medical condition: Intrahepatic Cholestasis of pregnancy
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004871 10008638 Cholestasis intrahepatic LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004628-40 Sponsor Protocol Number: MRX-801 Start Date*: 2021-01-29
    Sponsor Name:Mirum Pharmaceuticals Inc
    Full Title: Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis ...
    Medical condition: Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome
    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
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000906-20 Sponsor Protocol Number: LUM001-601 Start Date*: 2015-05-13
    Sponsor Name:Shire Human Genetic Therapies Inc
    Full Title: An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Alagille Syndrome (ALGS) ...
    Medical condition: Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    17.1 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001211-22 Sponsor Protocol Number: MRX-502 Start Date*: 2019-10-29
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: MRX-502: Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis ...
    Medical condition: Progressive Familial Intrahepatic Cholestasis (PFIC) In patients with progressive familial intrahepatic cholestasis (PFIC), impairment of the egress of bile acids from the liver leads to cholestasi...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) HU (Completed) PL (Completed) AT (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002325-38 Sponsor Protocol Number: A4250-008 Start Date*: Information not available in EudraCT
    Sponsor Name:Albireo AB
    Full Title: An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 2)
    Medical condition: Progressive Familial Intrahepatic Cholestasis Types 1 and 2
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) SE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) BE (Completed) ES (Prematurely Ended) IT (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003395-39 Sponsor Protocol Number: MRX-503 Start Date*: 2020-02-14
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: MRX-503: An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis (PFIC)
    Medical condition: In patients with progressive familial intrahepatic cholestasis (PFIC), impairment of the egress of bile acids from the liver leads to cholestasis, hepatocellular injury and damage, and progressive ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) PL (Completed) FR (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005373-43 Sponsor Protocol Number: LUM001-304 Start Date*: 2014-08-05
    Sponsor Name:Lumena Pharmaceuticals Inc
    Full Title: Long-Term, Open-Label Study with a Double-Blind, Placebo Controlled, Randomized Drug Withdrawal Period of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients wit...
    Medical condition: Alagille Syndrome
    Disease: Version SOC Term Classification Code Term Level
    17.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) PL (Completed) BE (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-004528-36 Sponsor Protocol Number: CAC-002-01 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: An open-label, single center, non-randomized, continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis.
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2011-004259-38 Sponsor Protocol Number: CAC-91-10-10 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: Investigation in the Pathogenesis of Liver Disease in Patients with Inborn Errors of bile Acid Metabolism
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-003832-54 Sponsor Protocol Number: LUM001-303 Start Date*: 2013-11-28
    Sponsor Name:Mirum Pharmaceuticals, Inc.
    Full Title: A MULTICENTRE EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND DURABILITY OF THE THERAPEUTIC EFFECT OF LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTI), IN THE TREATME...
    Medical condition: Alagille syndrome (ALGS). This is an example of cholestatic liver disease in children. In patients with Alagille syndrome, impairment of the egress of bile acids from the liver leads to cholestasis...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002338-21 Sponsor Protocol Number: A4250-005 Start Date*: Information not available in EudraCT
    Sponsor Name:Albireo AB
    Full Title: A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children with Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)
    Medical condition: Progressive Familial Intrahepatic Cholestasis Types 1 and 2
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) FR (Completed) GB (Completed) NL (Completed) ES (Completed) BE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004011-28 Sponsor Protocol Number: A4250-012 Start Date*: 2021-01-26
    Sponsor Name:Albireo AB
    Full Title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT)
    Medical condition: Alagille Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) NL (Completed) BE (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000996-36 Sponsor Protocol Number: A4250-015 Start Date*: 2021-10-14
    Sponsor Name:Albireo AB
    Full Title: An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)
    Medical condition: Alagille Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned)
    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: 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: 2018-004946-41 Sponsor Protocol Number: SP-PP18 Start Date*: 2019-09-12
    Sponsor Name:Dr. Virgilio P. Carnielli,
    Full Title: Personalized versus standard parenteral nutrition for preterm infants with a birth weight greater than 1250 grams: a phase IV randomized clinical trial
    Medical condition: Growth of preterm infants with a birth weight greater than 1250g on parenteral nutrition.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) IT (Completed)
    Trial results: (No results available)
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