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Clinical trials for Bile acids

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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  • 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   44335   clinical trials with a EudraCT protocol, of which   7366   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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    84 result(s) found for: Bile acids. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    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: 2018-003575-34 Sponsor Protocol Number: 301084 Start Date*: 2018-11-29
    Sponsor Name:Professor, Ph.d. MD. Filip Krag Knop
    Full Title: Treatment of bile acid malabsorption with liraglutid
    Medical condition: Bile acid malabsoprtion is a disease in which there is a large spill-over of bileacids to the larger intestines. This causes watery diarrheas and abdominal symptoms.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10080051 Bile acid diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002512-27 Sponsor Protocol Number: NL44774.068.13 Start Date*: 2013-11-25
    Sponsor Name:Maastricht University
    Full Title: The role of bile acids in human brown adipose tissue metabolism
    Medical condition: Healthy subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002762-12 Sponsor Protocol Number: SJ-674 Start Date*: 2021-12-07
    Sponsor Name:Zealand University Hospital
    Full Title: The prevalence of bile acid diarrhéa and the effect of budesonid on the bile acid homeostasis in patients with microscopic colitis
    Medical condition: Microscopic colitis Bile acid diarrhea
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-003777-28 Sponsor Protocol Number: OBADIAH1 Start Date*: 2012-04-26
    Sponsor Name:Imperial College London and Imperial College Healthcare NHS Trust
    Full Title: Obeticholic acid treatment in patients with bile acid diarrhoea: an open-label, pilot study of mechanisms, safety and symptom response.
    Medical condition: Bile acid diarrhoea (also known as bile acid malabsorption)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-004491-10 Sponsor Protocol Number: CAC-001-01 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: An Open-Label, Single-Center, Nonrandomized Study to Compare the Therapeutic Efficacy of To Be Marketed (TBM) Cholic Acid Capsules with that of the Currently Used (CU) Formulation of Cholic Acid Ca...
    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: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2006-003712-22 Sponsor Protocol Number: URT-14/BIO Start Date*: 2006-10-23
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers
    Medical condition: Primary Biliary Cirrhosis Stage I-III
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001452-22 Sponsor Protocol Number: SJ-641 Start Date*: 2018-08-29
    Sponsor Name:Zealand University Hospital
    Full Title: Treatment effect of colesevelam for bile acid diarrhoea
    Medical condition: Bile acid diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10069703 Bile acid malabsorption PT
    20.1 10017947 - Gastrointestinal disorders 10066557 Chronic diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-001054-84 Sponsor Protocol Number: 2004/W/GI/02 Start Date*: 2005-02-16
    Sponsor Name:NHS Lothian- University Hospitals Division
    Full Title: A comparison of the efficacy of dietary hydroxypropylcellulose and questran as therapeutic agents in bile acid induced diarrhoea
    Medical condition: these patients will have bile acid induced diarrhoea identified by an increased serum 7a-OH-cholestenone. and will have a history of one of 1. ileal resection 2. idiopathic bile acid diarrhoea.3. ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002217-22 Sponsor Protocol Number: SJ-546 Start Date*: 2016-09-02
    Sponsor Name:Sjællands University Hospital, Køge
    Full Title: Validation of stimulated ∆FGF19 for diagnosing bile acid diarrhoea
    Medical condition: Bile acid malabsorption / bile acid diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    19.1 10017947 - Gastrointestinal disorders 10069703 Bile acid malabsorption PT
    19.1 10017947 - Gastrointestinal disorders 10066557 Chronic diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2005-005843-24 Sponsor Protocol Number: RIFA+UDCA Start Date*: 2006-02-23
    Sponsor Name:Hanns-Ulrich Marschall
    Full Title: Studie på effekten av rifampicin och ursodeoxycholsyra på gallipider och deras transport och avgiftning hos patienter med kolesterolgallstenar.
    Medical condition: Gallstone disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000667-74 Sponsor Protocol Number: CV006 Start Date*: 2021-11-30
    Sponsor Name:Medisch Centrum Leeuwarden BV
    Full Title: The effect of bile acid binding with colesevelam on postprandial glucose concentrations in patients after RYGB and cholecystectomy : a meal test study
    Medical condition: Post Bariatric Hypoglycemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10059038 Postprandial hypoglycemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002924-17 Sponsor Protocol Number: A3384-001 Start Date*: 2014-01-27
    Sponsor Name:Albireo AB
    Full Title: A double-blind, randomized, placebo-controlled, study to demonstrate the efficacy and safety of 250 mg or 1 g A3384 administered orally twice daily for two weeks to patients with Bile Acid Malabsor...
    Medical condition: Patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002965-67 Sponsor Protocol Number: 57877.018.016 Start Date*: 2017-07-07
    Sponsor Name:AMC
    Full Title: An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and ...
    Medical condition: Primary biliairy cholangitis (PBC) Non-alcoholic steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001531-32 Sponsor Protocol Number: Obadiah-2 Start Date*: 2019-12-20
    Sponsor Name:Imperial College Healthcare NHS Trust
    Full Title: OBADIAH-2: A randomised, double-blind, placebo-controlled trial of two doses of obeticholic acid and placebo in patients with primary bile acid diarrhoea
    Medical condition: Bile acid diarrhoea (also known as bile acid malabsorption)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10080051 Bile acid diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-001000-42 Sponsor Protocol Number: 1144/2020 Start Date*: 2020-07-09
    Sponsor Name:Medical University of Vienna
    Full Title: The relationship of cholesterol-lowering drugs with steroid HORMONEs, bile acids, vitamin D, the immune system and related diseases such as depression and osteoporosis
    Medical condition: Patients with a diagnosed hyperlipidemia treated with statins (with either simvastatin <=20 mg, atorvastatin <=10 mg or rosuvastatin <=10 mg - random allocation), or with atorvastatin >=40 mg or r...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    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: 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: 2019-001528-37 Sponsor Protocol Number: Cholzuur Start Date*: 2020-04-09
    Sponsor Name:Cbusinez
    Full Title: Long-term safety study of personalized magistral prepared cholic acid capsules in patients with bile acid synthesis defects
    Medical condition: Patients with phenotypically mild Zellweger Spectrum Disorder (ZSD) or a Single Enzyme Defect (SED) in bile acid synthesis.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
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