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Clinical trials for Bile acid synthesis

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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    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).

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    13 result(s) found for: Bile acid synthesis. Displaying page 1 of 1.
    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: 2011-004491-10 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: 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: 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: 2017-001762-13 Sponsor Protocol Number: 747-401 Start Date*: 2018-08-01
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepa...
    Medical condition: Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) BE (Completed) HU (Prematurely Ended) EE (Prematurely Ended) LT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-002575-17 Sponsor Protocol Number: 747-213 Start Date*: 2019-07-25
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects w...
    Medical condition: Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) FR (Trial now transitioned) SE (Completed) ES (Restarted) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) SK (Prematurely Ended) DE (Trial now transitioned) CZ (Trial now transitioned) LT (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) PL (Completed) AT (Completed) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-005558-21 Sponsor Protocol Number: LUM001-401 Start Date*: 2015-03-25
    Sponsor Name:Lumena Pharmaceuticals LLC
    Full Title: A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Primary Sclerosing Cholan...
    Medical condition: Primary sclerosing cholangitis (PSC) is a chronic cholestatic liver disease of unknown aetiology. PSC is characterized by inflammation and fibrosis of the intra- and extrahepatic biliary tree re...
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-005346-38 Sponsor Protocol Number: LUM001-302 Start Date*: 2013-06-11
    Sponsor Name:Lumena Pharmaceuticals, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN THE TREATMENT OF CHOLESTAT...
    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 cholestasi...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-001241-20 Sponsor Protocol Number: 747-214 Start Date*: 2022-11-23
    Sponsor Name:INTERCEPT PHARMACEUTICALS INC.
    Full Title: A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in S...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-000482-36 Sponsor Protocol Number: LUM001-201 Start Date*: 2013-07-08
    Sponsor Name:Lumena Pharmaceuticals, Inc.
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA)...
    Medical condition: Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead ...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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: 2019-004941-34 Sponsor Protocol Number: GFT505B-319-1 Start Date*: 2020-10-09
    Sponsor Name:IPSEN Pharma SAS
    Full Title: A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Ina...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10034176 PBC LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
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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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