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Clinical trials for Chenodeoxycholic acid

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   44334   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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    13 result(s) found for: Chenodeoxycholic acid. Displaying page 1 of 1.
    EudraCT Number: 2021-003823-14 Sponsor Protocol Number: CDCA-PK Start Date*: 2021-11-16
    Sponsor Name:Amsterdam UMC
    Full Title: Pharmacokinetic cross-over study of compounded chenodeoxycholic acid.
    Medical condition: CTXCT
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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: 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: 2016-004692-53 Sponsor Protocol Number: SJ-434 Start Date*: 2017-03-01
    Sponsor Name:Zealand University Hospital Køge
    Full Title: Changes in bile acid homeostasis and stool habits after cholecystectomy
    Medical condition: Post cholecystectomy bile acid diarrhoea/malabsorption
    Disease: Version SOC Term Classification Code Term Level
    19.1 10017947 - Gastrointestinal disorders 10069703 Bile acid malabsorption PT
    19.1 10042613 - Surgical and medical procedures 10008611 Cholecystectomy PT
    19.1 10017947 - Gastrointestinal disorders 10066557 Chronic diarrhoea LLT
    19.1 10019805 - Hepatobiliary disorders 10057229 Post cholecystectomy syndrome PT
    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: 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: 2010-023241-29 Sponsor Protocol Number: 747-204 Start Date*: 2011-02-10
    Sponsor Name:Intercept Pharmaceuticals Inc
    Full Title: A Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Obeticholic Acid (INT-747) for the Treatment of Portal Hypertension (PESTO)
    Medical condition: Portal Hypertension in Patients with Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10036200 Portal hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-013348-35 Sponsor Protocol Number: 7915 Start Date*: 2009-08-04
    Sponsor Name:University Medical Center Utrecht
    Full Title: (Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease.
    Medical condition: Patients with quiescent Crohn’s colitis, defined as a Crohn’s Disease Activity Index <150 ; non-IBD patients will serve as disease controls.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011400 Crohn's colitis LLT
    9.1 10011401 Crohn's disease LLT
    9.1 10011402 Crohn's disease (colon) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    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: 2011-000813-37 Sponsor Protocol Number: OCABSGS Start Date*: 2012-05-16
    Sponsor Name:Sahlgrenska Academy
    Full Title: Effects of obeticholic acid on hepatic fatty acid/triglyceride metabolism and hepatobiliary detoxification/elimination in morbidly obese and gallstone patients.
    Medical condition: Fatty liver disease, morbid obesity, gallstone disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10029530 Non-alcoholic fatty liver LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003609-41 Sponsor Protocol Number: 3545 Start Date*: 2016-05-27
    Sponsor Name:King's College London [...]
    1. King's College London
    2. Guy's and St Thomas' NHS Foundation Trust
    Full Title: The renoprotective effects of Ursodeoxycholic acid in patients with type 1 diabetes and albuminuria
    Medical condition: Type 1 diabetes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-002225-30 Sponsor Protocol Number: 69HCL18_0957 Start Date*: 2019-07-18
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Impact of low protein diet supplemented with ketoanalogues on uremic toxins production and glucose metabolism in chronic kidney disease_KETO GUT study
    Medical condition: chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10076412 Chronic kidney disease stage 5 LLT
    20.0 100000004857 10076411 Chronic kidney disease stage 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    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
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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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