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Clinical trials for Anti-mitochondrial antibody

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    11 result(s) found for: Anti-mitochondrial antibody. Displaying page 1 of 1.
    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: 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: 2021-001431-56 Sponsor Protocol Number: NUT-2/PBC Start Date*: 2022-03-07
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patien...
    Medical condition: primary biliary cholangitis
    Disease: Version SOC Term Classification Code Term Level
    27.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Prematurely Ended) FI (Prematurely Ended) BE (Completed) FR (Completed) NO (Prematurely Ended) NL (Completed) DK (Prematurely Ended)
    Trial results: (No results available)
    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: 2019-000204-14 Sponsor Protocol Number: GS-US-428-4194 Start Date*: 2019-09-11
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis
    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: FI (Prematurely Ended) BE (Completed) AT (Completed) GB (GB - no longer in EU/EEA) DK (Prematurely Ended) FR (Completed) ES (Restarted) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002965-67 Sponsor Protocol Number: 57877.018.016 Start Date*: 2017-07-07
    Sponsor Name:AMC
    Full Title: An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and ...
    Medical condition: Primary biliairy cholangitis (PBC) Non-alcoholic steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    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: 2021-000007-21 Sponsor Protocol Number: 212620 Start Date*: 2021-08-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants wit...
    Medical condition: Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC).
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10064190 Cholestatic pruritus PT
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) IT (Completed) CZ (Completed) GR (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000422-16 Sponsor Protocol Number: UCAB-CT-05 Start Date*: 2022-07-26
    Sponsor Name:Umecrine Cognition AB
    Full Title: A randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, safety and tolerability, and preliminary efficacy of two dose levels of golexanolone in subjects wit...
    Medical condition: Primary biliary cholangitis (PBC)
    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: HU (Trial now transitioned) GR (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002416-41 Sponsor Protocol Number: 201000 Start Date*: 2017-02-17
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primar...
    Medical condition: Primary biliary cholangitis (PBC)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10019805 - Hepatobiliary disorders 10008604 Cholangitis PT
    19.0 10040785 - Skin and subcutaneous tissue disorders 10037087 Pruritus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001961-34 Sponsor Protocol Number: RDG-1/PBC Start Date*: 2021-02-02
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of 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: DE (Completed) GB (GB - no longer in EU/EEA) HU (Prematurely Ended) SK (Prematurely Ended) NL (Prematurely Ended) BE (Completed) PL (Prematurely Ended) IT (Prematurely Ended)
    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
    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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