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Clinical trials for Antimycobacterial

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   44335   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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    5 result(s) found for: Antimycobacterial. Displaying page 1 of 1.
    EudraCT Number: 2017-003374-14 Sponsor Protocol Number: SAV008-01 Start Date*: 2018-04-06
    Sponsor Name:Savara ApS
    Full Title: An Open-label, non-controlled, multicenter, Pilot clinical Trial of Inhaled Molgramostim in subjects with Antibiotic-resistant non-tuberculosis mycobacterial (NTM) infection
    Medical condition: Treatment-resistant pulmonary non-tuberculosis mycobacterial (NTM) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10062207 Mycobacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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: 2010-019694-15 Sponsor Protocol Number: ML25252 Start Date*: 2010-09-28
    Sponsor Name:N.V. Roche S.A.
    Full Title: Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorti...
    Medical condition: Rheumatoid Arthritis in adult
    Disease: Version SOC Term Classification Code Term Level
    13.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003079-16 Sponsor Protocol Number: INS-416 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen ...
    Medical condition: Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
    Disease: Version SOC Term Classification Code Term Level
    22.1 10021881 - Infections and infestations 10061229 Lung infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) FR (Trial now transitioned) DE (Ongoing) AT (Trial now transitioned) HU (Completed) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002545-42 Sponsor Protocol Number: INS-415 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous M...
    Medical condition: Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) HU (Completed) AT (Completed) NL (Completed) GR (Completed) IT (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
    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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