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    Summary
    EudraCT Number:2014-003066-24
    Sponsor's Protocol Code Number:MW2012-01-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-01-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003066-24
    A.3Full title of the trial
    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 (SOC) treatment
    Studio multicentrico, multinazionale, randomizzato, controllato, in aperto, eseguito su bambini con ustioni termiche, al fine di valutare l¿efficacia e la sicurezza di Nexobrid confrontandolo con il trattamento standard (SOC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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 (SOC) treatment
    Studio multicentrico, multinazionale, randomizzato, controllato, in aperto, eseguito su bambini con ustioni termiche, al fine di valutare l¿efficacia e la sicurezza di Nexobrid confrontandolo con il trattamento standard (SOC)
    A.3.2Name or abbreviated title of the trial where available
    A multicenter, multinational, randomized, controlled, open label study, performed in children with t
    Studio multicentrico, multinazionale, randomizzato, controllato, in aperto, eseguito su bambini con
    A.4.1Sponsor's protocol code numberMW2012-01-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMEDIWOUND LTD
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMediWound Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeon Research
    B.5.2Functional name of contact pointCristina d'Altilia
    B.5.3 Address:
    B.5.3.1Street AddressC.so Valdocco 2
    B.5.3.2Town/ cityTorino
    B.5.3.3Post code10122
    B.5.3.4CountryItaly
    B.5.4Telephone number00393331173304
    B.5.5Fax number0034987216243
    B.5.6E-mailcrdaltilia@leonresearch.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NEXOBRID - - 2 G - POLVERE E GEL PER GEL - USO CUTANEO. - POLVERE:FLACONCINO (VETRO) GEL: FLACONE (VETRO) - POLVERE: 2 G GEL: 20 G - 1 FLACONCINO + 1 FLACONE
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMA GMBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/107
    D.3 Description of the IMP
    D.3.1Product nameNexobrid
    D.3.2Product code D03BA03
    D.3.4Pharmaceutical form Cutaneous powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMiscela di enzimi (Bromelina)
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NEXOBRID - - 2 G - POLVERE E GEL PER GEL - USO CUTANEO. - POLVERE:FLACONCINO (VETRO) GEL: FLACONE (VETRO) - POLVERE: 2 G GEL: 20 G - 1 FLACONCINO + 1 FLACONE
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMA GMBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/107
    D.3 Description of the IMP
    D.3.1Product nameNexobrid
    D.3.2Product code [D03BA03]
    D.3.4Pharmaceutical form Cutaneous powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeMiscela di enzimi (Bromelina)
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 compare NexoBrid to standard of care (SOC).
    L'obiettivo dello studio ¿ quello di valutare la sicurezza e il beneficio clinico di NexoBrid nei bambini ospedalizzati (0-18 anni) con ustioni termiche di parziale e/o profondo spessore del 1-30% TBSA e di confrontare NexoBrid con lo standard di cura (SOC).
    E.1.1.1Medical condition in easily understood language
    Dead tissue of a burn wound has to be removed to promote healing of the wound.
    Tessuto morto di una ferita da ustione che deve essere rimosso per promuovere la guarigione della ferita.
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10043418
    E.1.2Term Thermal burns
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is:
    -To demonstrate enzymatic eschar removal efficacy of NexoBrid by providing earlier, complete eschar removal
    -To demonstrate enzymatic eschar removal efficacy of NexoBrid by reducing patients¿ surgical burden and resulting in non inferior final outcomes of cosmesis and function as compared to SOC.
    -To assess the safety of NexoBrid compared to SOC.
    L'obiettivo principale dello studio ¿:
    -Dimostrare l'efficacia enzimatica di NexoBrid nella rimozione dell'escara di NexoBrid fornendo prima, la rimozione completa dell'escara
    -Dimostrare l'efficacia enzimatica di NexoBrid nella rimozione dell'escara riducendo nei pazienti l'onere chirugica e con conseguanti risultati finali di cosmesi e funzionalit¿ non inferiori al SOC.
    -Valutare la sicurezza di NexoBrid confrontandolo con il SOC.
    E.2.2Secondary objectives of the trial
    The following secondary objectives are assessed compared between SOC and NexoBrid:
    1.Reduction in surgical need- Incidence of surgical excision performed for eschar removal. This Endpoint (EP) supplements the primary EP by further assessing NexoBrid¿s impact on the reduction in surgical needs.
    2.Incidence of autograft performed in deep partial thickness wounds
    3.Percent area of deep partial thickness wounds autografted
    4.Incidence of wound closure
    5.Time to reach complete wound closure assessed in days, starting from Randomization date.
    6.Cosmesis assessment using MVSS
    7.Long term Quality of Life will be measured using EQ5D at wk 12 and mths 6, 12, 18 and 24 following the confirmatory wound closure visit.
    8.Long term functionality evaluation of the extremities (using the ¿Lower Extremity Functional Scale¿ and 'QuickDASH' questionnaires and 'Range Of Motion' measurements) will be evaluated at wk 12 and mths 6, 12, 18 and 24 following the confirmatory wound closure visit.

    I seguenti obiettivi secondari sono valutati tra SOC e NexoBrid:
    1.Riduzione della necessit¿-incidenza chirurgica nell¿escissione chirugica effettuata per l¿eliminazione dell¿escara. Questo endpoint (EP) completa la EP primaria valutando ulteriormente l'impatto del NexoBrid sulla riduzione del fabbisogno chirurgico.
    2.Incidenza di autotrapianto eseguito in ferite profonde a spessore parziale
    3.Percentuale di aerea di ferite profonde a spessore parziale autotrapiantata
    4.Incidence di chiusura della ferita
    5.Tempo per raggiungere la completa chiusura della ferita valutato in giorni, a partire dalla data di randomizzazione.
    6. Valutazione della cosmesi utilizzando MVSS
    7. Sar¿ misurata la qualit¿ della vita a lungo termine utilizzando EQ5D alla settimana 12 e ai mesi 6, 12, 18 e 24 a seguito della visita di conferma dela chiusura della ferita.
    8.valutazione della funzionalit¿ a lungo termine delle estremit¿ (utilizzando la ¿Scala funzionale dell¿arto inferiore¿ e il questionario ¿QuickDA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria- Patient level
    1. Stage 1: Males and females between 4 years to 18 years of age,
    Stage 2 (upon approval of DSMB): Males and females between 0 years to 18 years of age,
    2. Thermal burns caused by fire/flame, scalds or contact.
    3. Patient total burn area = 1% DPT and/or FT;
    4. Patient total burn area should be = 30% TBSA, SPT, DPT and/or FT in depth;
    5. Signed written informed consent by a legal guardian can be obtained within 84 hours of the burn injury.

    Inclusion Criteria - Wound level
    At least one wound (a continuous burn area which can be treated in one session; might include several anatomical areas) in a patient should meet all following criteria:
    1. Wound that is = 1% TBSA (DPT and/or FT) (not including face, perineal or genital),
    2. Wound is composed of DPT and/or FT in depth. Superficial partial thickness areas may be included in the wound area only if cannot be separated from deeper areas (e.g. surrounded by or mixed with DPT areas) and might interfere with the treatment of the deeper areas,
    3. Wound that is potentially intended for surgical eschar removal,
    4. Wound’s blisters can be unroofed, as judged by the investigator.
    1. Fase 1: Maschi e femmine dai 4 anni ai 18 anni di età.
    Fase 2 (con l'approvazione del Comitato di Monitoraggio dei Dati e della Sicurezza): Maschi e femmine tra anni a 18 anni di età
    2. Ustioni termiche causate da fuoco/fiamma, scottature o contatto.
    3. La zona di ustioni totale del paziente dovrebbe essere = 1% Spessore Parziale e/o totale;
    4. La zona di ustioni totale del paziente dovrebbe essere = 30% della superficie corporea totale, profonditá superficiale, parziale e/o totale;
    5. Firmato il consenso informato scritto da un tutore legale può essere ottenuto entro 84 ore dall'ustione.

    Criterio dell'Inclusione - Livello della ferita
    Almeno una ferita (una zona di ustione continua che può essere trattata in una seduta, può comprendere numerosi aree anatomiche) in un paziente dovrebbe soddisfare tutti i seguenti criteri:
    1. La ferita che è > 1% della superficie corporea totale (SCT) (profonditá parziale e/o totale) (non compresi il viso, il perineale o il genitale).
    2. La ferita è composta dallo Spessore Parziale Profondo e/o a tutto spessore in profondità. Le zone dello spessore parziale profondo possono essere incluse nella zona della ferita solo se non possono essere separate da zone più profonde (per esempio circondato da o miscelato con le aree di Spessore Parziale Profondo) e potrebbero interferire con il trattamento delle zone più profonde,
    3. La ferita che è destinata per la rimozione chirurgica dell'escara,
    4. Le vesciche delle ferite possano non essere coperte, come giudicato dallo sperimentatore.
    E.4Principal exclusion criteria
    1. Patients weighing less than 3kg,
    2. Patients who are unable to follow study procedures and follow up period,
    3. Patients with electrical or chemical burns,
    4. Patient with a continuous burn area above 15% TBSA,
    5. Patients with no DPT and/or FT burn area (only SPT wounds),
    6. Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling = 80% of the trunk circumference),
    7. The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
    8. Patients with diagnosed infections as described in Section 13.2.6 of study protocol;
    9. Diagnosis of smoke inhalation injury;
    10. Patients with pre-enrolment wounds which are covered by eschar saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of >12h SSD treatment);
    11. Patients with pre-enrolment escharotomy;

    12. Pregnant women (positive pregnancy test) or nursing mothers,
    13. Poorly controlled diabetes mellitus (HbA1c>9%),
    14. Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases, broncho-pneumonia, steroid dependent asthma or uncontrolled asthma),
    15. Known conditions which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to the regional lymph nodes, obesity),
    16. Any known conditions that would preclude safe participation in the study or adding further risk to the basic acute burn trauma (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, pulmono-cardiovascular, liver or neoplastic disease),
    17. ASA greater than 2 (see Appendix 13- ASA classification system in study protocol)
    18. Chronic systemic steroid intake,
    19. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
    20. Current (within 12 months prior to screening) suicide attempt,
    21. Enrollment in any investigational drug trial within 4 weeks prior to screening,
    22. Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for males and >2 units for females) or drug abuse12,
    23. Prisoners and incarcerated
    24. Patients who might depend on the clinical study site or investigator.
    25. Patient expresses objection to participate in the study;
    26. Patients with other severe cutaneous trauma at the same sites as the burns (i.e. blunt, avulsion or deep abrasion) or previous burn(s) at the same treatment site(s);
    27. General condition of patient would contraindicate surgery.
    1. I pazienti di peso inferiore a 3kg,
    2. I pazienti che non sono in grado di seguire le procedure dello studio e del periodo di follow-up,
    3. I pazienti con ustioni elettriche o chimiche,
    4. Il paziente con una zona di bruciatura continua superiore al 15% della Superficie Corporea Totale (SCT),
    5. I pazienti con la zona di bruciatura senza Spessore Parziale Profondo e/o la zona di bruciatura a Tutto Spessore (solo ferite con Spessore Parziale Superficiale),
    6. Il paziente con le ustioni circonferenziali del torace anteriore/posteriore di fuoco/fiamma, > 15% della Superficie Corporea Totale (SCT) (Circonferenziale è definito come accerchiamento di > 80% della circonferenza del torace),
    7. Le seguenti fasciature di pre-arruolamento: a. Flammacerium, b. Nitrato d'argento (AgNO3),
    8. Pazienti con le infezioni diagnosticate come descritto nella Sezione 13.2.5 del protocollo dello studio;
    9. Eventuali segni o storia che possono indicare l'inalazione di fumo,
    10. Pazienti con ustioni di pre-arruolamento che sono coperti di escara pesantemente saturata con iodio o da pseudo escara dello (SSD) Standard Sample Description (es pseudo escara come risultato di trattamento SSD Standard Sample Description),
    11. Pazienti con escarotomia di pre-arruolamento,
    12. Le donne in gravidanza (test di gravidanza positivo) o madri che allattano,
    13. Diabete mellito scarsamente/insufficientemente controllato (HbA1c> 9%),
    14. La malattia cardio-polmonare nota, le malattie polmonari con ossigeno-dipendente, broncopolmonite, asma dipendente steroidi o asma non controllata).
    15. Le condizioni note che interferiscono con la circolazione (la malattia vascolare periferica, l'edema, la linfedema, la chirurgia ai linfonodi regionali e l'obesità),
    16. Le eventuali condizioni note che potrebbero precludere la partecipazione sicura allo studio o aggiungere l'ulteriore rischio alla base del trauma dell'ustione acuta (così come le malattie immuno-compromessi, i traumi in pericolo di vita, i disturbi della coagulazione pre-esistente grave, pulmono-cardiovascolare, la malattia del fegato o neoplastica),
    17. L'ASA superiore a 2 (vedi Appendice 13 nel protocollo dello studio)
    18. L'assunzione cronica di steroidi sistemici.
    19. Storia di allergia e/o sensibilità nota all'ananas, alla papaia, alla Bromelina o alla papaina,
    20. Tentativo di suicidio corrente (entro 12 mesi prima dello screening),
    21. L'arruolamento in qualsiasi sperimentazione di farmaco in studio/sperimentale entro 4 settimanw prima dello screening,
    22. Attuale abuso (entro 12 mesi prima dello screening) di alcol (consumo giornaliero > 3 unità per i maschi e >2 unità per le femmine) o abuso di droghe ,
    23. Prigionieri e incarcerati
    24. I pazienti che potrebbero dipendere dal luogo dello studio clinico o dallo sperimentatore.
    25. Patienti che esprimono obiezioni alla partecipazione allo studio;
    26. Pazienti con altri traumi cutanei severi nell stesso sito dell'ustione (es. avulsione o abrasione profonda) o precedenti ustioni nello stesso sito di trattamento;
    27. Generali condizioni del paziente che possano rappresentare una controindicazione per l'intervento chirurgico.
    E.5 End points
    E.5.1Primary end point(s)
    1. Earlier eschar removal (in days): Demonstrate superiority over SOC for eschar removal as measured by a survival analysis of incidence of complete eschar removal as a function of time. Eschar removal will be measured at the end of the debridement starting from randomization date.
    2. Reduction in surgical needs: Demonstrate superiority over SOC in reduction in surgical need for excisional eschar removal as measured by an analysis of % wound area surgically excised for eschar removal (tangential/ minor/ avulsion/ Versajet and/or dermabrasion excision).
    3. Cosmesis and Function: Demonstrate non-inferiority to SOC in quality of scars of burns (using POSAS) treated with NexoBrid, measured at 24 months from wound closure.
    1. Rimozione dell'escara precedente (in giorni): dimostrare la superiorità rispetto al
    SOC per la rimozione dell'escara misurata da un'analisi di sopravvivenza
    dell'incidenza della rimozione completa dell'escara in funzione del tempo. La
    rimozione dell'escara verrà misurata alla fine del debridement a partire dalla data di
    randomizzazione.
    2. Riduzione delle esigenze chirurgiche: dimostrare la superiorità rispetto alla SOC
    nella riduzione della necessità chirurgica di rimozione escara escisionale misurata
    mediante un'analisi della% della zona della ferita asportata chirurgicamente per
    rimozione escara (tangenziale / minore / avulsione / Versajet e / o escissione
    dermoabrasione).
    3. Cosmesi e funzione: dimostrazione della non inferiorità al SOC in termini di
    qualità delle cicatrici delle ustioni (usando POSAS) trattate con NexoBrid, misurate a
    24 mesi dalla chiusura della ferita.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Start of randomization
    2. End of eschar removal
    3. 24 months from wound closure.
    1. Inizio della randomizzazione
    2. Fine della rimozione dell'escara
    3. 24 mesi dalla chiusura della ferita.
    E.5.2Secondary end point(s)
    1. Reduction in surgical need- Incidence of surgical excision performed for eschar removal. This endpoint supplements the primary EP by further assessing NexoBrid¿s impact on the reduction in surgical needs.
    2. Incidence of autograft performed in deep partial thickness wounds only
    3. Percent area of deep partial thickness wounds autografted
    4. Incidence of wound closure
    5. Time to reach complete wound closure assessed in days, starting from Randomization date
    6. Cosmesis assessment using MVSS at 12 weeks and months, 6, 12, 18 and 24 following the confirmatory wound closure visit.
    7. Long term Quality of Life will be measured using EQ5D at 12 weeks and months 6, 12, 18 and 24 following to the confirmatory wound closure visit.
    8. Long term functionality evaluation of the extremities (using the ¿Lower Extremity Functional Scale¿ and 'QuickDASH' questionnaires and 'Range Of Motion' measurements) will be evaluated at 12 weeks and months 6, 12, 18 and 24 months following to the confirmatory wound closure visit.
    ; 1. Reduction in surgical need- Incidence of surgical excision performed for eschar removal. This endpoint supplements the primary EP by further assessing NexoBrid¿s impact on the reduction in surgical needs. 2. Incidence of autograft performed in deep partial thickness wounds only 3. Percent area of deep partial thickness wounds autografted 4. Incidence of wound closure 5. Time to reach complete wound closure assessed in days, starting from Randomization date 6. Cosmesis assessment using MVSS at 12 weeks and months, 6, 12, 18 and 24 following the confirmatory wound closure visit. 7. Long term Quality of Life will be measured using EQ5D at 12 weeks and months 6, 12, 18 and 24 following to the confirmatory wound closure visit. 8. Long term functionality evaluation of the extremities (using the ¿Lower Extremity Functional Scale¿ and 'QuickDASH' questionnaires and 'Range Of Motion' measurements) will be evaluated at 12 weeks and months 6, 12, 18 and 24 months following to the confirmatory wound closure visit.
    1. Riduzione delle necessità chirurgiche - Incidenza dell'escissione chirurgica
    eseguita per la rimozione dell'escara. Questo endpoint completa l'EP primario
    valutando ulteriormente l'impatto di NexoBrid sulla riduzione delle esigenze
    chirurgiche.
    2. Incidenza dell'autotrapianto eseguita solo su ferite profonde a spessore parziale
    3. Area percentuale di ferite profonde a spessore parziale autoinnestate
    4. Incidenza della chiusura della ferita
    5. Tempo per raggiungere la chiusura completa della ferita valutato in giorni, a
    partire dalla data di randomizzazione
    6. Valutazione della cosmesi con MVSS a 12 settimane e mesi, 6, 12, 18 e 24 dopo la
    visita di chiusura della ferita di conferma.
    7. La qualità della vita a lungo termine sarà misurata utilizzando l'EQ5D a 12
    settimane e mesi 6, 12, 18 e 24 dopo la visita di chiusura della ferita di conferma.
    8. La valutazione della funzionalità a lungo termine delle estremità (utilizzando i
    questionari "Scala funzionale per le estremità inferiori" e "QuickDASH" e le
    misurazioni "Range Of Motion") sarà valutata a 12 settimane e mesi 6, 12, 18 e 24 mesi
    successivi alla visita di conferma della chiusura della ferita.; 1. Ia riduzione della necessit¿ chirurgica - L'incidenza dell'asportazione chirurgica eseguita per la rimozione dell'escara. Questo endpoint integra gli endpoint primari valutando ulteriormente l'impatto di NexoBrid sulla riduzione delle cure chirurgiche.
    2. L'incidenza di autotrapianto eseguito nelle ferite a spessore parziale profonde solo.
    3. in % della zona delle ferite autotranpiantate a spessore parziale profondo
    4. Incidenza di cicatrizzazione della ferita
    5. Il tempo per raggiungere la completa cicatrazzazione della ferita valutata in giorni, a partire dalla data di Randomizzazione
    6. La valutazione della cosmesi utilizzando il MVSS (Modified Vancouver Scar Scale) a 12 settimane e a 6, 12, 18 e 24 mesi in seguito alla conferma della visita medica di cicatrizzazione della ferita.
    7. La Qualit¿ di Vita a lungo termine sar¿ misurata utilizzando EQ5D a 12 settimane e a 6, 12, 18 e 24 mesi in seguito alla conferma della visita medica di cicatrizzazione della ferita.
    8. La valutazione di funzionalit¿ a lungo termine degli arti (utilizzando il LEFS 'Valutazione Funzionale dell'Arto Inferiore' e i questionari 'QuickDASH' e le misurazioni della 'Gamma di Movimenti') saranno valutati a 12 settimane e a 6, 12, 18 e 24 mesi in seguito alla conferma della visita medica di cicatrizzazione della ferita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -time until complete eschar removal has been achieved.
    -end of the topical agent soaking period.
    -Time to reach complete wound closure assessed in days, starting from Randomization date.
    -3, 6, 12, 18 and 24 months following to the confirmatory wound closure visit.; -time until complete eschar removal has been achieved.
    -end of the topical agent soaking period.
    -Time to reach complete wound closure assessed in days, starting from
    Randomization date.
    -3, 6, 9, 12, 18 and 24 months following to the confirmatory wound
    closure visit.
    tempo fino al completamento della rimozione completa dell'escara.
    -fine del periodo di ammollo dell'agente topico.
    -Tempo per raggiungere la chiusura completa della ferita valutata in giorni, a
    partire dalla data di randomizzazione.
    -3, 6, 12, 18 e 24 mesi dopo la visita di chiusura della ferita di conferma.; - tempo fino al completamento della rimozione completa dell'escara.
    - fine del periodo di ammollo dell'agente topico.
    - Tempo per raggiungere la chiusura completa della ferita valutato in giorni, a
    partire da
    Data di randomizzazione.
    -3, 6, 9, 12, 18 e 24 mesi dopo la ferita di conferma
    visita di chiusura.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicit¿
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Valutazione cieca delle escare
    Scar evaluation is blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Braccio comparatore ¿ lo standard di cura
    Comparator arm is Standard of care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Austria
    Belgium
    Bulgaria
    Czechia
    France
    Germany
    Italy
    Romania
    Slovakia
    Spain
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 1
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 4
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 45
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 85
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-01-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Both parents/legal guardians are asked to consent on child participation. Children at the age of 7 to <18 get their own additional informed consent form. If minor goes to site with one parent the other parents signature can be obtained later asap.

    Entrambi i genitori / tutori legali sono invitati a dare il consenso sulla partecipazione dei bambini. I bambini di et¿ compresa tra i 7 e i 18 ottengono il loro proprio consenso informato aggiuntivo. Se un minore si presenta presso il centro con un
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 160
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients are treated according to standard of care after end of participation in the trial.
    I pazienti sono trattati secondo lo standard di cura dopo la fine della partecipazione alla sperimentazione.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-15
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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