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Clinical trials for Bezlotoxumab

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: Bezlotoxumab. Displaying page 1 of 1.
    EudraCT Number: 2017-000070-11 Sponsor Protocol Number: MK-6072-001 Start Date*: 2017-12-11
    Sponsor Name:Merck Sharp & Dohme Corp.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK 6072, Human Monoclonal An...
    Medical condition: Prevention of recurrent Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10012748 Diarrhoea, Clostridium difficile LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) PT (Completed) SE (Prematurely Ended) DE (Completed) NO (Completed) HU (Completed) PL (Completed) Outside EU/EEA GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2021-004924-14 Sponsor Protocol Number: BSTEP Start Date*: 2022-04-21
    Sponsor Name:Leiden University Medical Center
    Full Title: New treatment strategy for patients with multiple recurrent Clostridioides difficile infection with bezlotoxumab as first option
    Medical condition: recurrent C. difficile infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10009657 Clostridium difficile colitis PT
    20.0 10021881 - Infections and infestations 10012748 Diarrhoea, Clostridium difficile LLT
    20.0 10021881 - Infections and infestations 10012734 Diarrhea, Clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-005473-10 Sponsor Protocol Number: BEYOND Start Date*: 2021-11-24
    Sponsor Name:Hellenic Institute for the Study of Sepsis
    Full Title: BEZLOTOXUMAB YIELDED OUTCOMES BY ADDRESSING PERSONALIZED NEEDS IN CLOSTRIDIOIDES DIFFICILE INFECTION: THE BEYOND DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL
    Medical condition: Clostridioides difficile Infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004862 10085158 Clostridioides difficile infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004994-94 Sponsor Protocol Number: 3415A-002 Start Date*: 2011-12-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to C. difficile toxin B), and MK-...
    Medical condition: Recurrence of Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) DE (Completed) CZ (Completed) FI (Completed) PL (Completed) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004590-90 Sponsor Protocol Number: 3415A-001 Start Date*: 2012-02-17
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium ...
    Medical condition: recurrence of Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) CZ (Completed) BE (Completed) DK (Completed) PT (Completed) AT (Completed) IT (Completed) GB (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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