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Clinical trials for Clofazimine

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   44334   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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    8 result(s) found for: Clofazimine. Displaying page 1 of 1.
    EudraCT Number: 2015-004440-19 Sponsor Protocol Number: CLAM320B2202 Start Date*: 2016-03-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 30-month multicenter, phase 2b/3, randomized, open label trial to evaluate the efficacy and safety of clofazimine administered orally in addition to background regimen compared to background regi...
    Medical condition: Treatment of multidrug-resistant pulmonary tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10070578 Multidrug resistant tuberculosis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Prematurely Ended) LT (Prematurely Ended)
    Trial results: View results
    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: 2021-002062-40 Sponsor Protocol Number: UMCN-AKF-21.04 Start Date*: 2021-11-29
    Sponsor Name:Radboud university medical center
    Full Title: Pharmacokinetic study with a loading dose of clofazimine in adult patients with nontuberculous mycobacterial disease
    Medical condition: Nontuberculous mycobacterial disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-003786-28 Sponsor Protocol Number: PERC2015 Start Date*: 2016-01-19
    Sponsor Name:Radboudumc
    Full Title: Pulmonary NTM disease: A regimen of ethambutol and azithromycin with as adjunctive rifampicin vs clofazimine.
    Medical condition: Fibrocavitary pulmonary disease caused by M.avium complex
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-005199-90 Sponsor Protocol Number: RHB-104-04 Start Date*: 2019-02-14
    Sponsor Name:RedHill Biopharma Ltd.
    Full Title: An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn’s Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study
    Medical condition: Moderately to Severely Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-001179-36 Sponsor Protocol Number: RHB-104-01 Start Date*: 2015-07-24
    Sponsor Name:RedHill Biopharma Ltd.
    Full Title: A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severe...
    Medical condition: Moderately to Severely Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) CZ (Completed) SK (Completed) BG (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)
    EudraCT Number: 2014-004108-31 Sponsor Protocol Number: RHB-104-03 Start Date*: 2015-08-27
    Sponsor Name:RedHill Biopharma Ltd.
    Full Title: A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Cr...
    Medical condition: Moderately Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) CZ (Prematurely Ended)
    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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