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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 3 of 4.
    EudraCT Number: 2011-004681-15 Sponsor Protocol Number: KIMCL_TS_2011-09 Start Date*: 2011-11-09
    Sponsor Name:Medizinische Universität Graz
    Full Title: Effects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis
    Medical condition: Up to 67% of PBC patients have an incomplete biochemical response to UDCA and remain at increased risk for progression to cirrhosis and liver-related death. In this study we will prospectively exam...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002996-91 Sponsor Protocol Number: CB8025-21629 Start Date*: 2017-02-21
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an in...
    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: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-003910-16 Sponsor Protocol Number: CB8025-31731 Start Date*: 2018-02-08
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
    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: GB (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    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: 2016-002442-23 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: 2015-004028-69 Sponsor Protocol Number: IRIBIL Start Date*: 2016-12-01
    Sponsor Name:Goethe-Universität Frankfurt, PD Fabian Finkelmeier
    Full Title: 5-Fluorouracil (5-FU), folinic acid and irinotecan (FOLFIRI) versus 5-FU and folinic acid as second-line chemotherapy in patients with biliary tract cancer (IRIBIL): a randomized open-label phase 2...
    Medical condition: biliary tract cancer not amedable for curative resection with progressive disease after first-line chematherapy with gemcitabine and cisplatin
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002802-30 Sponsor Protocol Number: GS-US-337-0124 Start Date*: 2014-03-12
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who ha...
    Medical condition: Chronic Genotype 1 and Genotype 4 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) IT (Completed) AT (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-003365-34 Sponsor Protocol Number: I4V-MC-JAIV Start Date*: 2019-05-02
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadeq...
    Medical condition: Primary Biliary Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10008604 Cholangitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-000633-39 Sponsor Protocol Number: FEC-TH Start Date*: 2012-05-21
    Sponsor Name:Fundación para la Formación e Investigación Sanitaria
    Full Title: Extracorporeal photopheresis in liver transplantation. Clinical trial phase I/II safety and efficacy in patients with progressive withdrawal of immunosuppression.
    Medical condition: Liver transplantation more than 2 years of evolution to complications of immunosuppression.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003310-24 Sponsor Protocol Number: UDCAPSCSURV Start Date*: 2015-10-09
    Sponsor Name:Sahlgrenska Academy
    Full Title: A Phase 3, Open-label, Randomized, Prospective Clinical Trial Evaluating the Efficacy of Stratified Treatment with Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy ...
    Medical condition: Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-018034-11 Sponsor Protocol Number: 2010vanco.psc Start Date*: 2013-04-29
    Sponsor Name:Karolinska Institutet
    Full Title: Open pilot study of treatment with vancomycin to children and adolescents with primary sclerosing cholangitis
    Medical condition: Primary Sclerosing Cholangitis (PSC) is a progressive disease of the biliary system which might lead to increased risk of cholangiocancer. PSC constitutes a common indication for adult liver transp...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005508-42 Sponsor Protocol Number: P05216 Start Date*: 2008-08-27
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008912 Chronic hepatitis C LLT
    9.1 10019744 Hepatitis C PT
    9.1 10021881 Infections and infestations SOC
    9.1 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) PT (Prematurely Ended) ES (Completed) NL (Completed) IT (Completed) BE (Completed) DE (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-001438-27 Sponsor Protocol Number: 48885 Start Date*: 2015-08-19
    Sponsor Name:Academic Medical Center
    Full Title: The effect of bezafibrate on cholestatic itch
    Medical condition: Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing) ES (Completed)
    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: 2020-002605-25 Sponsor Protocol Number: AIO-HEP-0120 Start Date*: 2021-03-24
    Sponsor Name:AIO-Studien-gGmbH
    Full Title: Neoadjuvant Bintrafusp alfa in patients with resectable biliary tract cancer (NEOBIL)
    Medical condition: Treatment-naive subjects with a diagnosis of resectable biliary tract cancer, confirmed by histopathology
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004593 Bile duct cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004597 Bile duct cancer resectable LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004598 Bile duct carcinoma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007289 Carcinoma bile duct LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004601 Bile duct carcinoma resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-004760-39 Sponsor Protocol Number: P05685 Start Date*: 2009-04-03
    Sponsor Name:Schering Plough Research Institute, A Division of Schering Corporation
    Full Title: A phase 3 safety and efficacy study of boceprevir in combination with peginterferon alfa-2a and ribavirin in subjects with chronic hepatitis C genotype 1 who failed prior treatment with peginterfer...
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008912 Chronic hepatitis C LLT
    9.1 10019744 Hepatitis C PT
    9.1 10021881 Infections and infestations SOC
    9.1 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-003367-19 Sponsor Protocol Number: NUC-5/PSC Start Date*: 2017-09-28
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis
    Medical condition: Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and ...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) LT (Completed) FI (Trial now transitioned) CZ (Prematurely Ended) BE (Completed) DK (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) SE (Completed) NO (Trial now transitioned) PL (Trial now transitioned) IE (Prematurely Ended) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005151-42 Sponsor Protocol Number: P05101 Start Date*: 2008-08-28
    Sponsor Name:Schering Plough Research Institute, A Division of Schering Corporation
    Full Title: A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    9.1 10008912 Chronic hepatitis C LLT
    9.1 10019744 Hepatitis C PT
    9.1 10021881 Infections and infestations SOC
    9.1 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) PT (Prematurely Ended) ES (Completed) IT (Completed) BE (Completed) DE (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-004864-38 Sponsor Protocol Number: P05411 Start Date*: 2009-10-02
    Sponsor Name:Schering Plough Research Institute, A Division of Schering Corporation
    Full Title: A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    13.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    13.1 10021881 - Infections and infestations 10019744 Hepatitis C PT
    13.1 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) BE (Completed) FR (Completed) PT (Completed) IT (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-005089-12 Sponsor Protocol Number: TRO19622 CL E Q 1159-1 Start Date*: 2008-02-05
    Sponsor Name:TROPHOS
    Full Title: Study title: Double-blind vs Placebo, Randomized, Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 500 mg QD for One Month in Patients with Non-Alcoholi...
    Medical condition: - Non Alcoholic Steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10053219 Non-alcoholic steatohepatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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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