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Clinical trials for Biliary injury

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   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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    19 result(s) found for: Biliary injury. Displaying page 1 of 1.
    EudraCT Number: 2008-004762-83 Sponsor Protocol Number: BILISCOPIN Start Date*: 2008-10-15
    Sponsor Name:AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
    Full Title: Evaluation of the diagnostic efficacy of the CT cholangiography performed by administering an intra-venous contrast medium with biliary excretion (Biliscopin) in patients with malignancies of the b...
    Medical condition: Patients with obstructive jaundice due to a biliary malignancy (Klatskin tumor, tumor of the middle or distal bile ducts or Galbladder tumors) Patients with post-cholecistectomy iatrogenic lesions ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10062883 LLT
    9.1 10004665 LLT
    9.1 10061008 LLT
    9.1 10004647 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-001424-12 Sponsor Protocol Number: 747-201 Start Date*: 2009-04-21
    Sponsor Name:Intercept Pharmaceuticals
    Full Title: A Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary Cirrhosis
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10019805 - Hepatobiliary disorders 10004661 Biliary cirrhosis primary PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) ES (Completed) AT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-001425-10 Sponsor Protocol Number: 747-202 Start Date*: 2008-10-13
    Sponsor Name:Intercept Pharmaceuticals
    Full Title: A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis
    Medical condition: Primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004661 Biliary cirrhosis primary PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) AT (Completed) NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-000145-12 Sponsor Protocol Number: 5997 Start Date*: 2012-08-15
    Sponsor Name:The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: Rituximab for the Treatment of Fatigue in Primary Biliary Cirrhosis (PBC)
    Medical condition: Severe fatigue in Primary Biliary Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10019805 - Hepatobiliary disorders 10004661 Biliary cirrhosis primary PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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: 2012-001960-31 Sponsor Protocol Number: S54348 Start Date*: 2013-05-03
    Sponsor Name:UZ Leuven
    Full Title: Combined drug Approach to Prevent Ischemia-reperfusion injury during Transplantation of Livers (CAPITL): a first-in-men study
    Medical condition: Investigation of the ischemia-reperfusion injury in patients who will undergo a liver transplantation after receiving a drug combination/multifactorial modulation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    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: 2012-003213-34 Sponsor Protocol Number: CH2012-001 Start Date*: 2012-11-13
    Sponsor Name:ISTITUTO CLINICO HUMANITAS
    Full Title: MEthylprednisoloneNacinHepatIcResections “MENHIR”
    Medical condition: patients candidate to liver resection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    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: 2018-001698-25 Sponsor Protocol Number: LIVERHOPE_EFFICACY Start Date*: 2018-07-24
    Sponsor Name:IDIBAPS
    Full Title: Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical t...
    Medical condition: Patients with decompensated cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10009209 Cirrhosis bilary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) IT (Completed)
    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: 2022-001634-10 Sponsor Protocol Number: SARO.21.001 Start Date*: 2023-01-23
    Sponsor Name:Zydus Therapeutics Inc.
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis.
    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: ES (Prematurely Ended) IS (Trial now transitioned)
    Trial results: (No results available)
    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: 2016-002442-23 Sponsor Protocol Number: GS-US-428-4025 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 Sclerosing Cholangitis Without Cirrhosis
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002198-20 Sponsor Protocol Number: CLNKLPTXIII07AT17 Start Date*: 2018-11-28
    Sponsor Name:Dr. Franz Köhler Chemie GmbH
    Full Title: A Prospective, randomized, single blind, multicentre Phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in organ transplantation (kidney, liver and pan...
    Medical condition: patients who will undergo kidney, liver or kidney-pancreatic transplantation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004778-81 Sponsor Protocol Number: IMMUWHY Start Date*: 2019-10-29
    Sponsor Name:Institut für Klinische Krebsforschung IKF GmbH
    Full Title: A phase II study of immunotherapy with durvalumab (MEDI4736) or durvalumab and tremelimumab, both combined with Y-90 SIRT therapy in patients with advanced stage intrahepatic biliary tract cancer (...
    Medical condition: Intrahepatic Biliary Tract Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10008594 Cholangiocarcinoma non-resectable LLT
    20.0 100000004864 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001810-13 Sponsor Protocol Number: GSN000350 Start Date*: 2021-12-11
    Sponsor Name:Genkyotex Suisse SA
    Full Title: TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elev...
    Medical condition: Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
    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: HU (Completed) DE (Completed) AT (Completed) FR (Completed) ES (Prematurely Ended) PL (Completed) IT (Completed) GR (Completed) SE (Completed) CZ (Completed) BE (Completed)
    Trial results: View results
    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 (Completed)
    Trial results: View results
    EudraCT Number: 2012-002120-33 Sponsor Protocol Number: HLSCS01-11 Start Date*: 2013-12-06
    Sponsor Name:AZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA
    Full Title: Human Liver Stem Cells (HLSCs) in patients suffering from liver-based inborn metabolic diseases causing life-threatening neonatal onset of hyperammonemic encephalopathy
    Medical condition: neonatal hyperammonemic encephalopathy associated with inborn liver metabolic diseases
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10059521 Methylmalonic aciduria PT
    14.1 10010331 - Congenital, familial and genetic disorders 10058299 Argininosuccinate lyase deficiency PT
    14.1 10010331 - Congenital, familial and genetic disorders 10052450 Ornithine transcarbamoylase deficiency PT
    14.1 10010331 - Congenital, familial and genetic disorders 10058297 Carbamoyl phosphate synthetase deficiency PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: IT (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
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