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Clinical trials for Cholic 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
  • 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   44337   clinical trials with a EudraCT protocol, of which   7367   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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    11 result(s) found for: Cholic acid. Displaying page 1 of 1.
    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: 2011-004259-38 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: 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: 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)
    EudraCT Number: 2010-022046-25 Sponsor Protocol Number: Zellweger Start Date*: Information not available in EudraCT
    Sponsor Name:Department of Pediatric Gastroenterology, Academic Medical Centre
    Full Title: Cholic acid treatment in Peroxisomal Biogenesis Disorders (Zellweger spectrum): biochemical and clinical effects.
    Medical condition: Peroxisomal biogenesis disorder Synonym: Zellweger spectrum disorder This syndrome encompasses a spectrum of severity in symptoms Previously the disorder was subdivided into three disorders based...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053706 Zellweger syndrome LLT
    12.1 10038275 Refsum's disease LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-005919-24 Sponsor Protocol Number: C/399/2002 Start Date*: 2006-07-19
    Sponsor Name:Dr. Falk Pharma Portugal
    Full Title: Randomized, multicenter, double blind, placebo controlled trial, for the evaluation of the efficacy and tolerability of ursodeoxycholic acid on the dissolution of cholesterol gallstones (<15mm) aft...
    Medical condition: Randomized multicenter double blind, placebo controlled trial, for the evaluation of the efficacy and tolerability of UDCA on the dissolution of cholesterol gallstones (<15mm) after 18 months of th...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    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: 2016-003817-80 Sponsor Protocol Number: GFT505B-216-1 Start Date*: 2017-05-22
    Sponsor Name:Genfit SA
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients Wit...
    Medical condition: Primary biliary cholangitis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004871 10034176 PBC LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    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: 2005-003625-46 Sponsor Protocol Number: SCG01SII Start Date*: 2006-03-28
    Sponsor Name:ITALCHIMICI SPA
    Full Title: EFFICACY OF ORAL SODIUM CROMOGLICATE IN THE IRRITABLE BOWEL SYNDROME: A DOUBLE BLIND PLACEBO CONTROLLED MULTICENTRE RANDOMISED STUDY
    Medical condition: IRRITABLE BOWEL SYNDROME
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) CZ (Completed) SK (Completed) PL (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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