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Clinical trials for Primary 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
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    The EU Clinical Trials Register currently displays   44336   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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    58 result(s) found for: Primary biliary cirrhosis. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2006-003712-22 Sponsor Protocol Number: URT-14/BIO Start Date*: 2006-10-23
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers
    Medical condition: Primary Biliary Cirrhosis Stage I-III
    Disease: Version SOC Term Classification Code Term Level
    12.1 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004040-70 Sponsor Protocol Number: BUC-56/PBC Start Date*: 2008-05-15
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsu...
    Medical condition: PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflamm...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) FR (Completed) AT (Completed) NL (Completed) FI (Completed) ES (Completed) HU (Completed) GB (Completed) LT (Completed) DK (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-002698-39 Sponsor Protocol Number: CB8025-21528 Start Date*: 2015-11-11
    Sponsor Name:CymaBay Therapeutics Inc.
    Full Title: A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response t...
    Medical condition: Primary Biliary Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000554-31 Sponsor Protocol Number: CNTO1275PBC2001 Start Date*: 2011-09-21
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an I...
    Medical condition: Primary Biliary Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001638-27 Sponsor Protocol Number: FFP104-001 Start Date*: 2014-10-15
    Sponsor Name:Fast Forward Pharmaceuticals, B.V.
    Full Title: A Phase I/II, Open Label, Multicenter, Pilot Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacodynamics of FFP104 in Subjects Previously Diagnosed with Primary Biliary Cirrhosi...
    Medical condition: Primary Biliary Cirrhosis (PBC)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (Completed)
    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: 2008-001524-31 Sponsor Protocol Number: URT-15/PBC Start Date*: 2008-08-26
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parame...
    Medical condition: Treatment of primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (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: 2006-006742-34 Sponsor Protocol Number: ezetimibe27 Start Date*: 2007-12-20
    Sponsor Name:Barts and The London NHS Trust
    Full Title: The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis.
    Medical condition: primary biliary cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005198-29 Sponsor Protocol Number: CB8025-31731-RE Start Date*: 2021-05-10
    Sponsor Name:CymaBay Therapeutics, Inc.
    Full Title: ASSURE: 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: DE (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) AT (Trial now transitioned) CZ (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-002404-18 Sponsor Protocol Number: NRL972-03/2006 (CIR) Start Date*: 2008-04-04
    Sponsor Name:Norgine Limited
    Full Title: A multi-centre, multi-national open study in patients with hepatic cirrhosis to characterise the association between the pharmacokinetics of NRL972 and disease severity
    Medical condition: Hepatic cirrhosis.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019641 Hepatic cirrhosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) IT (Completed) BG (Completed) AT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2022-001883-91 Sponsor Protocol Number: CLIN-60190-452 Start Date*: 2022-10-07
    Sponsor Name:Ipsen Bioscience Inc
    Full Title: A Phase I, Open Label, Randomised, Balanced, Single-dose, Two-period, Two-sequence Crossover-design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-ma...
    Medical condition: This is a study to evaluate the effects of food on the bioavailability of elafibranor in healthy adult participants. It is part of a clinical development program for the IMP, the intended indicatio...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    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: 2016-004599-23 Sponsor Protocol Number: GSN000300 Start Date*: 2017-08-10
    Sponsor Name:Genkyotex SA
    Full Title: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and wit...
    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: BE (Completed) GB (Completed) ES (Completed) GR (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001590-41 Sponsor Protocol Number: CLJN452X2201 Start Date*: 2016-01-11
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
    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 (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010335-41 Sponsor Protocol Number: RRK3728 Start Date*: 2009-06-30
    Sponsor Name:University of Birmingham
    Full Title: A MULTICENTRE, PHASE II, OPEN LABEL, RANDOMISED CONTROLLED TRIAL OF REPEATED AUTOLOGOUS INFUSIONS OF G-CSF MOBILISED CD133+ BONE MARROW STEM CELLS IN PATIENTS WITH CIRRHOSIS
    Medical condition: Liver Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10001806 Alpha-1 anti-trypsin deficiency PT
    14.1 10019805 - Hepatobiliary disorders 10009211 Cirrhosis liver LLT
    14.1 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    14.1 10019805 - Hepatobiliary disorders 10064844 Compensated cirrhosis LLT
    14.1 10019805 - Hepatobiliary disorders 10019641 Hepatic cirrhosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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
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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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