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Clinical trials for Nexobrid

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   44336   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: Nexobrid. Displaying page 1 of 1.
    EudraCT Number: 2014-001672-55 Sponsor Protocol Number: MW2010-03-02 Start Date*: 2014-09-22
    Sponsor Name:MediWound Ltd.
    Full Title: A multicenter, multinational, randomized, controlled, assessor blinded study, performed in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid compared to Gel Vehicle and c...
    Medical condition: The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar in hospitalized subjects with thermal burns.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004863 10043418 Thermal burns HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) RO (Completed) LV (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003066-24 Sponsor Protocol Number: MW2012-01-01 Start Date*: 2014-12-17
    Sponsor Name:MediWound Ltd.
    Full Title: A multicenter, multinational, randomized, controlled, open label study, performed in children with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to standard of care (SO...
    Medical condition: The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-18 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compa...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004863 10043418 Thermal burns HLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) SK (Completed) DE (Completed) BE (Completed) AT (Prematurely Ended) BG (Prematurely Ended) NL (Prematurely Ended) FR (Completed) SE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001909-53 Sponsor Protocol Number: MW2012-01-01.BExt Start Date*: 2022-10-24
    Sponsor Name:MediWound Ltd.
    Full Title: Long Term (>30 months following wound closure) assessments of cosmesis, function and quality of life in pediatric subjects following participation in study MW2012-01-01 evaluating the efficacy and ...
    Medical condition: To evaluate and compare the cosmesis, function and QoL in children who had their target burn wounds eschar removed by NexoBrid or by SOC in study MW2012-01-01
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000057-44 Sponsor Protocol Number: MW2008-09-03 Start Date*: 2013-09-05
    Sponsor Name:Mediwound Ltd
    Full Title: Feasibility Study: Enzymatic Debridement in Patients (Adults) with Partial Thickness and Full Thickness Burns - Protocol MW 2008-09-03
    Medical condition: Eschar removal from partial thickness and full thickness burns
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001466-25 Sponsor Protocol Number: MW2013-07-10 Start Date*: 2015-06-18
    Sponsor Name:MediWound, Ltd.
    Full Title: A multicenter, prospective, randomized, vehicle controlled, assessor blinded study performed in subjects with hard to heal wounds, to evaluate the efficacy and safety of enzymatic debridement with ...
    Medical condition: Hard to heal venous leg ulcers, diabetic lower extremity ulcers and traumatic/post operative wounds.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    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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