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Clinical trials for Bedaquiline

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    5 result(s) found for: Bedaquiline. Displaying page 1 of 1.
    EudraCT Number: 2021-006613-10 Sponsor Protocol Number: TMC207LEP3001 Start Date*: 2024-08-13
    Sponsor Name:Janssen Pharmaceutica NV
    Full Title: A Phase 3, Multicenter, Open-label, Rater-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Bedaquiline for the Treatment of Multibacillary Leprosy When Combined With Rifampicin...
    Medical condition: Multibacillary Leprosy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10024232 Leprosy, unspecified LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2012-005492-13 Sponsor Protocol Number: TMC207TBC1002 Start Date*: 2013-03-26
    Sponsor Name:Janssen infectious diseases BVBA
    Full Title: A Phase I, open-label, randomized, 3-way crossover study in 3 Panels of healthy, adult subjects to assess the relative bioavailability of TMC207 following single-dose administration of two pediatri...
    Medical condition: Multi-drug resistant tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003372-23 Sponsor Protocol Number: TMC207-C211 Start Date*: 2015-05-28
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antimycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of...
    Medical condition: Multi-drug resistant tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2010-021125-12 Sponsor Protocol Number: TMC207TBC3001 Start Date*: 2011-09-16
    Sponsor Name:Janssen Infectious Diseases BVBA
    Full Title: Early access of TMC207 in combination with other anti-tuberculosis (TB) drugs in subjects with extensively drug resistant (XDR) or pre-XDR pulmonary TB
    Medical condition: Tuberculosis (TB)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000050-10 Sponsor Protocol Number: FORMaT001 Start Date*: 2023-01-02
    Sponsor Name:University of Queensland
    Full Title: Finding the Optimal Regimen for Mycobacterium abscessus Treatment
    Medical condition: Mycobacterium abscessus pulmonary disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10064789 Mycobacterium abscessus infection PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    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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