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Clinical trials for Biliary cirrhosis

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    69 result(s) found for: Biliary cirrhosis. Displaying page 2 of 4.
    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: 2005-001454-24 Sponsor Protocol Number: IPSS B025-L Start Date*: 2005-06-08
    Sponsor Name:RIEMSER Arzneimittel AG
    Full Title: An Open Labelled, Clinical Phase II Study With Oral Cis-U-Hydroxy-L-Proline (CHP) in 45 Patients With: - Chronic viral hepatitis - Chronic alcoholic liver diseases without cirrhosis - Compens...
    Medical condition: Chronic viral hepatitis, Chronic alcoholic liver diseases without cirrhosis, Compensated alcoholic liver cirrhosis, Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    1.1 10019805 SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed)
    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: 2013-002416-27 Sponsor Protocol Number: INFECIR2 Start Date*: 2013-10-23
    Sponsor Name:Fundacio Clinic per a la recerca biomedica
    Full Title: Albumin administration in the prevention of hepatorenal syndrome and death in patients with cirrhosis, bacterial infections other than spontaneous bacterial peritonitis and high risk of hospital mo...
    Medical condition: Patients with advanced cirrhosis (serum creatinine > 1.2 mg/dl, serum sodium < 130 mEq/l and/or serum bilirubin > 4 mg/dl), signs of systemic inflammation and urinary infection, pneumonia, skin/sof...
    Disease: Version SOC Term Classification Code Term Level
    16.0 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    16.0 10019805 - Hepatobiliary disorders 10008954 Chronic liver disease and cirrhosis LLT
    16.0 10019805 - Hepatobiliary disorders 10019641 Hepatic cirrhosis PT
    16.0 10019805 - Hepatobiliary disorders 10064704 Decompensated cirrhosis LLT
    16.0 10019805 - Hepatobiliary disorders 10009213 Cirrhosis of liver LLT
    16.0 10019805 - Hepatobiliary disorders 10009211 Cirrhosis liver LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) ES (Ongoing) IT (Prematurely Ended) BE (Prematurely Ended) DE (Prematurely Ended) AT (Prematurely Ended) DK (Prematurely Ended) IE (Prematurely Ended) GB (Prematurely Ended) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-001326-26 Sponsor Protocol Number: NI-0801-03 Start Date*: 2011-05-27
    Sponsor Name:NovImmune S.A.
    Full Title: PIANO. Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI-0801, a fully human anti-CXCL10 monoclonal antibody. An open label single arm study to investigate the safety and eff...
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended)
    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)
    EudraCT Number: 2011-004728-36 Sponsor Protocol Number: 747-301 Start Date*: 2012-03-30
    Sponsor Name:Intercept Pharmaceuticals, Inc.
    Full Title: A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) NL (Completed) DE (Completed) SE (Completed) AT (Completed) ES (Completed) GB (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-003528-62 Sponsor Protocol Number: EDP305-201 Start Date*: 2018-12-05
    Sponsor Name:Enanta Pharmaceuticals, Inc.
    Full Title: A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis...
    Medical condition: Primary Biliary Cholangitis (PBC)
    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: DE (Completed) GB (Completed) BE (Completed) ES (Completed) AT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000963-15 Sponsor Protocol Number: MATCH0.1 Start Date*: 2016-01-19
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: MAcrophage Therapy for Liver Cirrhosis (MATCH)
    Medical condition: Liver Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10024667 Liver cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    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 (Completed) AT (Completed) DK (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-000974-22 Sponsor Protocol Number: MRX-701 Start Date*: 2021-01-29
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Biliary Atresia after Hepatoportoenterostomy
    Medical condition: Biliary atresia (BA) is a rare, inflammatory condition of the biliary tree that presents in the first weeks of life and leads to bile duct obstruction and consequent liver injury, fibrosis and cirr...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10004653 Biliary atresia LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) PL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-002160-28 Sponsor Protocol Number: hepatology_MT_2005-05 Start Date*: 2005-09-23
    Sponsor Name:Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology
    Full Title: Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis
    Medical condition: Reduction of cardiovascular risk may become key for the management of PBC. Therefore information on safety and efficacy (lipid-lowering effects) of statins in chronic cholestatic disorders is essen...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    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: 2014-005012-42 Sponsor Protocol Number: 747-302 Start Date*: 2016-01-05
    Sponsor Name:Intercept Pharmaceuticals Inc.
    Full Title: A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT S...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Prematurely Ended) AT (Prematurely Ended) BE (Completed) DK (Prematurely Ended) FI (Prematurely Ended) GB (GB - no longer in EU/EEA) EE (Prematurely Ended) ES (Prematurely Ended) NL (Prematurely Ended) FR (Ongoing) DE (Completed) BG (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-001260-36 Sponsor Protocol Number: MEN-TOS Start Date*: 2008-03-04
    Sponsor Name:AZIENDA OSPEDALIERA POLICLINICO DI MODENA
    Full Title: Terapia PEG-Interferone alfa 2B+Ribavirina versus terapia PEG-Interferone alfa 2B + Ribavirina+ Terapia ormonale sostitutiva (TOS) nella prevenzione della progressione della fibrosi epatica nell’ep...
    Medical condition: Women in post-menopause with Chronic HCV positive hepatitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004070-42 Sponsor Protocol Number: A4250PBCpruritus Start Date*: 2014-12-09
    Sponsor Name:Sahlgrenska Academy
    Full Title: An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacy and Safety of A4250 in Patients with Primary Biliary Cirrhosis and Cholestatic Pruritus
    Medical condition: Primary biliary cirrhosis complicated by cholestatic pruritus.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002443-42 Sponsor Protocol Number: GS-US-427-4024 Start Date*: 2017-01-09
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Biliary Cholangitis Without Cirrhosis
    Medical condition: Primary Biliary Cholangitis
    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: GB (Completed) AT (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: 2006-004419-24 Sponsor Protocol Number: RHMMED0687 Start Date*: 2007-03-16
    Sponsor Name:Southampton University Hospitals Trust (R&D)
    Full Title: The Use of Sulfasalazine as an Anti-fibrotic in Acute Alcoholic Hepatitis
    Medical condition: Acute Alcoholic Hepatitis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2008-003766-26 Sponsor Protocol Number: 25-12-59 Start Date*: 2009-10-12
    Sponsor Name:Southampton University Hospitals NHS Trust
    Full Title: The effects of purified n-3 fatty acids on serum biomarkers and cardiovascular risk markers in a randomized placebo controlled trial in patients with non alcoholic fatty liver disease
    Medical condition: Non alcoholic fatty liver disease (NAFLD). This fatty liver disease may progress to a chronic condition that sometimes deteriorates further to cirrhosis and even liver carcinoma. To date there is n...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10031743 Other chronic nonalcoholic liver disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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