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Clinical trials for Mitochondrial Disease

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   44347   clinical trials with a EudraCT protocol, of which   7375   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    90 result(s) found for: Mitochondrial Disease. Displaying page 5 of 5.
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    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: 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: 2018-003546-16 Sponsor Protocol Number: Debio1143-106 Start Date*: 2019-03-06
    Sponsor Name:Debiopharm International SA
    Full Title: SMARTPLUS-106: Debio 1143 a SMAC Mimetic In Combination With Nivolumab In Patients Failing Prior PD-1/PD-L1 Treatment: A Basket Trial A dose-optimization, exploratory phase Ib/II study to assess...
    Medical condition: Solid Tumors
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    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: 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: 2004-000816-24 Sponsor Protocol Number: FRAN-03-001 Start Date*: 2004-10-28
    Sponsor Name:Abbott France
    Full Title: A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen versus Lopinavir/Ritonavir in Combination with Lamivudine/Zidovudine in Antir...
    Medical condition: HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    7.0 10020192 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005098-29 Sponsor Protocol Number: 2017PZY5K7 Start Date*: 2021-07-09
    Sponsor Name:DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II
    Full Title: Novel therapeutic strategies to reduce coronary microvascular obstruction and to OPTImize non-culprit stenoses revascularization in ST-Elevation acute Myocardial Infarction Randomized, no-profit, ...
    Medical condition: Patients with acute ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) defined by at least one non-culprit stenosis (NCS) with angiographic severity between 3...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10007582 Cardiac insufficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004376-18 Sponsor Protocol Number: ANRSHB07 Start Date*: 2021-06-10
    Sponsor Name:Inserm ANRS
    Full Title: ANRS HB07 IP-cure-B proof of concept (PoC) clinical trial. Educating the liver immune environment through TLR8 stimulation followed by NUC discontinuation
    Medical condition: Chronic Hepatitis B virus (HBV) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    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: 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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