Flag of the European Union EU Clinical Trials Register Help

Clinical trials for 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   43861   clinical trials with a EudraCT protocol, of which   7284   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    66 result(s) found for: Cholestasis. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2008-001323-64 Sponsor Protocol Number: 7/2008/O/Sper Start Date*: 2008-03-12
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: PHASE III DOUBLE BLIND PLACEBO CONTROLLED RANDOMIZED STUDY ON THE EFFICACY OF URSODEOXYCHOLIC ACID FOR THE TREATMENT OF INTRAHEPATIC CHOLESTASIS OF PREGNANCY
    Medical condition: INTRAHEPATIC CHOLESTASIS OF PREGNANCY
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049055 Cholestasis of pregnancy LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-002717-39 Sponsor Protocol Number: 07OB004 Start Date*: 2008-03-13
    Sponsor Name:University of Nottingham
    Full Title: Pilot study for a trial of ursodeoxycholic acid (UDCA) and/or early delivery for obstetric cholestasis
    Medical condition: Obstetric cholestasis (OC) is a serious problem in pregnancy. It affects about 1 in 150 pregnancies, about 4500 women per year in the UK. Affected women develop severe itching and sometimes jaundic...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049055 Cholestasis of pregnancy LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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: 2008-008689-11 Sponsor Protocol Number: 3/15.12.2008 Start Date*: Information not available in EudraCT
    Sponsor Name:Children's Memorial Health Institute
    Full Title: Efficacy and safety of omega – 3 based lipid solution (Omegaven) in comparison with Lipofundin LCT/MCT in reducing cholestasis in children on parenteral nutrition – randomized double – blind clinic...
    Medical condition: Parenteral nutrition associated liver disease (PNALD) MedDRA LLT: total parenteral nutrition MedDRA PT: parenteral nutrition MedDRA LLT: liver cholestasis MedDRA PT: cholestasis
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: (No results available)
    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 (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    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 (Ongoing)
    Trial results: View results
    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: 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 (Ongoing) BE (Ongoing) ES (Prematurely Ended) IT (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    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: 2019-003395-39 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 (Ongoing) GB (GB - no longer in EU/EEA) BE (Ongoing) PL (Ongoing) FR (Ongoing) HU (Ongoing) AT (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    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: 2013-003833-14 Sponsor Protocol Number: LUM001-501 Start Date*: 2014-01-30
    Sponsor Name:Mirum Pharmaceuticals, Inc.
    Full Title: OPEN LABEL STUDY OF THE EFFICACY AND LONG TERM SAFETY OF LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN THE TREATMENT OF CHOLESTATIC LIVER DISEASE IN PEDIATRIC PATIE...
    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 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-004011-44 Sponsor Protocol Number: UofATURRIFIC Start Date*: 2020-05-20
    Sponsor Name:The University of Adelaide
    Full Title: A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruri...
    Medical condition: Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FI (Ongoing) GB (GB - no longer in EU/EEA) SE (Ongoing)
    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: 2018-001171-20 Sponsor Protocol Number: CB8025-31735 Start Date*: 2018-11-23
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intole...
    Medical condition: Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cho...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Temporarily Halted) HU (Prematurely Ended) DE (Prematurely Ended) FR (Prematurely Ended) AT (Prematurely Ended) PL (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) BE (Completed) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000680-26 Sponsor Protocol Number: Taurine05 Start Date*: 2005-06-27
    Sponsor Name:North west London Hospital Trust
    Full Title: A randomised double blind controlled crossover trial of intravenous taurine supplementation in parenteral nutrition as an effective treatment for reducing hepatobiliary complications in chronic int...
    Medical condition: Complications of intravenous nutrition include cholestatic liver disease. This is one of the main causes of death during long-term home parenteral nutrition (HPN) and a study in 2000 found that 65%...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-003990-10 Sponsor Protocol Number: PHOCCC04-01 Start Date*: 2005-01-18
    Sponsor Name:Axcan Pharma Inc. (Axcan Pharma International B.V. is a subsidiary of Axcan Pharma Inc.)
    Full Title: Multicenter, open-label, randomised, controlled phase III clinical study of the efficacy and safety of photodynamic therapy using porfimer sodium for injection as palliative treatment for unresecta...
    Medical condition: Unresectable Cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    7.0 10008593 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004348-27 Sponsor Protocol Number: CB8025-32048 Start Date*: 2021-07-07
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an In...
    Medical condition: Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (c...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) FR (Completed) PL (Completed) NL (Completed) IT (Ongoing) AT (Completed) DK (Completed) RO (Ongoing)
    Trial results: (No results available)
    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
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 25 21:36:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA