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    Summary
    EudraCT Number:2014-003066-24
    Sponsor's Protocol Code Number:MW2012-01-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-16
    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 ConcernedSpain - AEMPS
    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
    Estudio abierto, multicéntrico, multinacional, aleatorio y controlado, llevado a cabo en niños con quemaduras térmicas, para evaluar la eficacia y seguridad de NexoBrid en comparación con el tratamiento estándar de cuidados (SOC, por sus siglas en inglés)
    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
    Estudio abierto, multicéntrico, multinacional, aleatorio y controlado, llevado a cabo en niños con quemaduras térmicas, para evaluar la eficacia y seguridad de NexoBrid en comparación con el tratamiento estándar de cuidados (SOC, por sus siglas en inglés)
    A.4.1Sponsor's protocol code numberMW2012-01-01
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/072/2014
    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 organisationLeón Research S.L
    B.5.2Functional name of contact pointCEO - Rocío García Cañamaque
    B.5.3 Address:
    B.5.3.1Street AddressC/ Burgo Nuevo 16-1ºG
    B.5.3.2Town/ cityLeón/León
    B.5.3.3Post code24001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034987261064
    B.5.5Fax number0034987216243
    B.5.6E-mailrgcanamaque@leonresearch.es
    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
    D.2.1.1.2Name of the Marketing Authorisation holderMediWound Germany GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder and gel for gel
    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.3.8INN - Proposed INNconcentrate of proteolytic enzymes enriched in bromelain
    D.3.9.3Other descriptive nameCONCENTRATE OF PROTEOLYTIC ENZYMES ENRICHED IN BROMELAIN
    D.3.9.4EV Substance CodeSUB91744
    D.3.10 Strength
    D.3.10.1Concentration unit gm/m2 gram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number111
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 typemixture of enzymes (Bromelain) extracted from pineapple stem
    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).
    Los objetivos principales del estudio son evaluar la seguridad y el beneficio clínico de NexoBrid en niños hospitalizados (0-18 años) con quemaduras térmicas de espesor parcial y profundo o de espesor completo del 1-30 % del ASCT y comparar NexoBrid con el estándar de cuidados (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.
    El tejido muerto de una herida por quemadura tiene que ser eliminado para favorecer la curación de la herida.
    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 17.0
    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.
    Los objetivos del estudio son:
    -Demostrar la eficacia de la extracción enzimática de la escara con NexoBrid al proporcionar una extracción completa y temprana de la escara.
    -Demostrar la eficacia de la extracción enzimática de la escara con NexoBrid al reducir la carga quirúrgica del paciente y al producir resultados finales de no inferioridad de cosmesis y función en comparación con el SOC.
    -Evaluar la seguridad de NexoBrid en comparación con el 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.
    Este estudio evaluará los siguientes criterios secundarios de valoración comparando el NexoBrid y el SOC: 1.Reducción en las necesidades quirúrgicas-Incidencia de la escisión quirúrgica realizada para la extracción de la escara.[...] 2.Incidencia del autoinjerto realizado en heridas de espesor parcial y profundo. 3.% de la zona de las heridas de espesor parcial y profundo autoinjertadas. 4.Incidencia del cierre de la herida. 5.Tiempo para alcanzar el cierre completo de la herida evaluado en días, a partir de la fecha de aleatorización. 6.Evaluación de la cosmesis mediante la Escala de cicatrices de Vancouver modificada. 7.Se medirá la calidad de vida a largo plazo mediante EQ5D a las 12 semanas y en los meses 6, 12, 18 y 24 tras la visita confirmatoria del cierre de la herida.
    8. Evaluación de funcionalidad de las extremidades a largo plazo (usando los cuestionarios "escala de funcionalidad de las extremidades inferiores" ,"QuickDASH"y las medidas de "Amplitud de movimiento") [...].
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    8.1.1 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 burns area should be between 1% to 30% TBSA (? 1% and ? 30% ; SPT, DPT and/or FT in depth),
    4.Signed written informed consent by a legal guardian can be obtained within 60 hours of the burn injury.
    8.1.2 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 (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.Wounds blisters can be unroofed, as judged by the investigator.
    Criterios de inclusión- a nivel de paciente
    1. Fase 1: Hombres y mujeres de entre 4 y 18 años,
    Fase 2 (después de la aprobación de la DSMB): Hombres y mujeres de entre 0 y 18 años.
    2. Quemaduras térmicas causadas por fuego o llama, escaldaduras o contacto.
    3. La zona de quemadura total del paciente debe ser de entre 1 a 30 % de TBSA (? 1 % y ? 30 % ; SPT, DPT o FT en profundidad),
    4. Se puede obtener el consentimiento informado por escrito y firmado de un tutor legal dentro de las 60 horas de producirse la lesión por quemadura.
    Criterios de inclusión- a nivel de herida
    Al menos una herida (una zona de quemadura continua que pueda tratarse en una sesión; podría incluir varias zonas anatómicas) en un paciente que debe cumplir los siguientes criterios:
    1. Herida que supone ? 1 % de TBSA (sin incluir cara, perineal o genital),
    2. Herida compuesta de DPT o FT en profundidad. Las zonas de espesor parcial y superficial pueden incluirse en la zona de herida únicamente si no se pueden separar de las zonas más profundas (por ejemplo, rodeadas por zonas de DPT o mezcladas con estas) y pudieran interferir con el tratamiento de las zonas más profundas.
    3. Herida destinada a la extracción quirúrgica de la escara,
    4. Las ampollas de la herida se pueden destapar, según el criterio del investigador.
    E.4Principal exclusion criteria
    1. Patients who are unable to follow study procedures and follow up period,
    2. Patients with electrical or chemical burns,
    3. Patient with a continuous burn area above 15% TBSA,
    4. Patients with no DPT and/or FT burn area (only SPT wounds),
    5. DPT and/or FT facial burn wounds from flame, flash, explosion >0.5% TBSA (scald and contact burns are allowed); study treatment of all facial burns is not allowed,
    6. Study treatment of perineal and/or genital burns is not allowed; however, a patient with these wounds may be enrolled but the wounds may not be designated as target wounds,
    7. Patient with circumferential anterior/posterior trunk fire/flame burns, >15% TBSA (Circumferential is defined as encircling ? 80% of the trunk circumference),
    8. The following pre-enrolment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
    9. Patients with diagnosed infections as described in Section 12.2.5 of study protocol,
    10. Any signs or history that may indicate smoke inhalation (e.g. flames in enclosed space, smoke and fumes on the patient and in mouth and nostrils, deep flame burns >0.5 %TBSA to the face, cough, hoarseness, stridor or breathing difficulty including tachypnea possibly related to smoke inhalation, etc.),
    11. Patients with pre-enrolment wounds which are covered by eschar saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
    12. Patients with pre-enrolment escharotomy,
    13. Pregnant women (positive pregnancy test) or nursing mothers,
    14. Poorly controlled diabetes mellitus (HbA1c>9%),
    15. Known Cardio-pulmonary disease, oxygen-dependent pulmonary diseases, broncho-pneumonia, steroid dependent asthma or uncontrolled asthma),
    16. Known conditions which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to the regional lymph nodes, obesity),
    17. 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 abuse ,
    23. Prisoners and incarcerated
    24. Patients who might depend on the clinical study site or investigator.
    1. Pacientes que no son capaces de seguir los procedimientos del estudio y el periodo de seguimiento,
    2. Pacientes con dedos carbonizados y quemados, de tercer grado en profundidad, posiblemente desprovistos de circulación,
    3. Pacientes con quemaduras eléctricas o químicas,
    4. Paciente con una zona de quemadura continua de más del 15 % de TBSA,
    5. Heridas por quemadura faciales de DPT o FT causadas por llama, fogonazo, explosión del >0,5 % de TBSA (se permiten las quemaduras por escaldadura o contacto); el tratamiento de estudio de todas las quemaduras faciales no está permitido,
    6. Tratamiento de estudio de quemaduras perineales o genitales no está permitido. Sin embargo, un paciente con estas heridas puede inscribirse aunque las heridas no se designen como heridas objetivo,
    7. Paciente con quemaduras en el tronco anterior, posterior o circunferencial por fuego o llama, de >15 % de TBSA (circunferencial se refiere a la circunferencia de ? 80 % del diámetro del tronco),
    8. Los siguientes vendajes antes de la inscripción: a. Flammacerium, b. Nitrato de plata (AgNO3),
    9. Pacientes con infecciones diagnosticadas según se describe en la Sección 12.2.5 del protocolo de estudio,
    10. Cualquier síntoma o historial que pueda indicar la inhalación de humo (por ejemplo, las quemaduras por llama en el cuerpo superior, llamas en lugares cerrados, humos y gases sobre el paciente y en boca y orificios nasales, así como quemaduras profundas por llama de >0,5 % de TBSA de la cara, tos, ronquera, estridor o dificultad para respirar que incluye taquipnea posiblemente relacionada con la inhalación de humos, etc.),
    11. Pacientes con heridas antes de la inscripción que están cubiertas con escara muy saturada en yodo o por pseudoescara con SDP (como la pseudoescara provocada por un tratamiento con SDP ),
    12. Pacientes con escaratomía antes de la inscripción,
    13. Mujeres embarazadas (con prueba de embarazo positivo) o madres en periodo de lactancia,
    14. Diabetes mellitus mal controlada (HbA1c>9 %),
    15. Enfermedad cardiopulmonar conocida (enfermedades pulmonares oxigenodependientes, bronconeumonía, asma dependiente de esteroides o asma no controlada),
    16. Afecciones conocidas que interfieran con la circulación (enfermedad vascular periférica, edema, linfedema, cirugía de los nódulos linfáticos regionales, obesidad),
    17. Cualquier afección conocida que pudiera impedir su participación segura en el estudio o riesgos adicionales para el trauma de quemadura agudo básico (como las enfermedades inmunodepresivas, trauma potencialmente mortal , trastornos de la coagulación graves preexistentes, enfermedad pulmo-cardiovascular, de hígado o neoplásica),
    18. ASA superior a 2 (consultar el Apéndice 13 del estudio de protocolo)
    19. Ingesta sistémica y crónica de esteroides,
    20. Historial de alergias o sensibilidad conocida a la piña, papaya, bromelaína o papaína,
    21. Intento de suicidio actual (dentro de los 12 meses antes del cribado),
    22. Inscripción a cualquier ensayo clínico de investigación en las 4 semanas anteriores al cribado,
    23. Abuso de drogas o alcohol (consumo diario > 3 unidades para hombres y >2 unidades para mujeres) actual (dentro de los 12 meses antes del cribado) ,
    24. Prisioneros o encarcelados o los pacientes que podrían depender del centro del estudio clínico o del investigador.
    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. Extracción de la escara temprana (en días): Demostrar la superioridad sobre el estándar de cuidados (SOC, por su siglas en inglés) para la extracción de la escara según un análisis de supervivencia e incidencia de una extracción total de escara en función del tiempo. La extracción de la escara se medirá al final del desbridamiento que empieza en la fecha de aleatorización.
    2. Reducción en las necesidades quirúrgicas: Demostrar la superioridad sobre el SOC en la reducción de necesidades quirúrgicas para la escisión de la escara según un análisis del % de la zona de la herida escindida para la extracción de la escara (escisión tangencial, menor, avulsión, Versajet o dermoabrasión).
    3. Cosmesis y función: Demostrar la no inferioridad del SOC en la calidad de las cicatrices de quemaduras (mediante la escala POSAS) que se han tratado con NexoBrid, calculado en 24 meses a partir del cierre de la herida.
    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. Inicio de la aleatorización
    2. Fin de la retirada de la escara
    3. 24 meses desde el cierre de la herida
    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. % 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. Reducción en las necesidades quirúrgicas - Incidencia de la escisión quirúrgica realizada para la extracción de la escara. Este criterio de valoración complementa al criterio de valoración (EP, por sus siglas en inglés) primario evaluando el impacto de NexoBrid en la reducción de las necesidades quirúrgicas.
    2. Incidencia del autoinjerto realizado en heridas de espesor parcial y profundo
    3. % de la zona de las heridas de espesor parcial y profundo autoinjertadas
    4. Incidencia del cierre de la herida
    5. Tiempo para alcanzar el cierre completo de la herida evaluado en días, a partir de la fecha de aleatorización
    6. Evaluación de la cosmesis mediante la Escala de cicatrices de Vancouver modificada (MVSS, por sus siglas en inglés) a las 12 semanas y en los meses 6, 12, 18 y 24 tras la visita confirmatoria del cierre de la herida.
    7. Se medirá la calidad de vida a largo plazo mediante EQ5D y el cuestionario de resultados por quemadura (BOQ, por su siglas en inglés) a las 12 semanas y en los meses 6, 12, 18 y 24 tras la visita confirmatoria del cierre de la herida.
    8. Evaluación de funcionalidad de las extremidades a largo plazo (usando los cuestionarios "escala de funcionalidad de las extremidades inferiores" y "QuickDASH", así como las medidas de "Amplitud de movimiento") que se llevará a cabo a las 12 semanas y en los meses 6, 12, 18 y 24 tras la visita confirmatoria del cierre de la herida.
    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, 9, 12, 18 and 24 months following to the confirmatory wound closure visit.
    - Tiempo hasta que se haya logrado la retirada completa de la escara.
    - Fin del periodo de absorción del agente tópico.
    - Tiempo para alcanzar el cierre completo de la herida evaluado en días, comenzando desde la fecha de aleatorización.
    -3, 6, 9, 12, 18 y 24 meses tras la visita confirmatoria del cierre de la herida.
    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
    Inmunogenicidad
    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
    La evaluación de la cicatriz es ciega
    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
    el brazo comparador es el Estandar de cuidados
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Bulgaria
    Czech Republic
    France
    Germany
    Israel
    Netherlands
    Romania
    Slovakia
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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
    UVUP
    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.1.1Number of subjects for this age range: 160
    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: 35
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 88
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 32
    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 2014-10-16. 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.
    Se les pide a ambos padres / tutores legales que den su consentimiento a la participación de sus hijos. Los niños de 7 a 18 años tienen su propio formulario de consentimiento informado adicional.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    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.
    Los pacientes son tratados de acuerdo con la estandares de cuidado tras finalizar su participación en el ensayo.
    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 Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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