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    Summary
    EudraCT Number:2017-002460-41
    Sponsor's Protocol Code Number:TBRU-dS-BA-PIIb
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-13
    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 number2017-002460-41
    A.3Full title of the trial
    A Phase IIb, prospective, intra-patient randomised controlled, multicentre study to evaluate the safety and efficacy of an autologous bio-engineered dermo-epidermal skin substitute (EHSG-KF) for the treatment of partial deep dermal and full thickness burns in adults in comparison to autologous split-thickness skin grafts (STSG)
    Studio multicentrico, prospettico, randomizzato e controllato intra-paziente, di fase IIb, sulla sicurezza ed efficacia di un sostituto cutaneo dermoepidermico bioingegnerizzato (EHSGKF) per il trattamento di ustioni a spessore parziale o a spessore completo negli adulti, in confronto con l'innesto di cute a spessore parziale autologa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to check if the use of a skin model engeneered in the laboratory by using your own skin cells (EHSG-KF), is safe and effective to treat partial deep dermal and full thickness burns in adults in comparison to the standard treatment used in current medicine (STSG).
    Studio di valutazione dell'utilizzo di un modello cutaneo ingegnerizzato in laboratorio a partire dalle cellule del paziente (EHSG-KF), per quanto riguarda sicurezza ed efficacia, nel trattamento di ustioni a spessore parziale o a spessore completo negli adulti, in confronto con il trattamento comunemente usato a livello medico (STSG).
    A.4.1Sponsor's protocol code numberTBRU-dS-BA-PIIb
    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 SponsorUniversity of Zurich, Tissue Biology Research Unit
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportWyss Zurich
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Zurich
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressWeinbergstrasse 35
    B.5.3.2Town/ cityZurich
    B.5.3.3Post code8092
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41446328261
    B.5.6E-mailFabienne.Hartmann-fritsch@wysszurich.ch
    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 No
    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/3/15/1596
    D.3 Description of the IMP
    D.3.1Product nameEHSG-KF
    D.3.2Product code EHSG-KF
    D.3.4Pharmaceutical form Cutaneous patch
    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 INNAutologous Skin Cells
    D.3.9.1CAS number na
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameHuman Skin Cells
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 10000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberH0004817
    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 No
    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 No
    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
    Adults with partial deep dermal and full thickness burns.
    Adulti affetti da ustioni cutanee a spessore parziale o a spessore completo.
    E.1.1.1Medical condition in easily understood language
    Adults with partial deep dermal and full thickness burns
    Adulti affetti da ustioni cutanee a spessore parziale o a spessore completo.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of EHSG-KF in comparison to meshed STSG
    based on:
     Ratio of covered surface area to biopsy site/donor site surface
    area 4 weeks post grafting
    Valutare l'efficacia di EHSG-KF rispetto all'innesto a rete di cute a spessore parziale sulla base di:
     Rapporto tra superficie dell'area coperta e dimensioni della superficie del prelievo bioptico/sito donatore 4 settimane dopo l'innesto;
    E.2.2Secondary objectives of the trial
    To evaluate the safety and efficacy of EHSG-KF in comparison to meshed
    STSG based on the assessment of:
     Infection
     Scar quality:
    o Cutometer® 3, 6, 12, 24 and 36 months post grafting
    o DSM II ColorMeter® 3, 6, 12, 24 and 36 months post
    grafting
    o POSAS-questionnaire 3, 6, 12, 24 and 36 months post
    grafting
     %Epithelialization at 4 weeks post grafting
     Graft take at 4-11 days post grafting
     %Epithelialization at each study visit (to estimate ‘time to complete
    epithelialization’)
     Incidence of wound closure at 8 and 12 weeks post grafting
     Assessment and reporting of all adverse events (expected and
    unexpected)
     QOL assessment (EQ-5D and BSHS-B)
     Healthcare resource utilization (direct healthcare costs, this
    questionnaire will not be handed out to patients)
    Valutare la sicurezza ed efficacia di EHSG-KF rispetto all'innesto a rete di cute a spessore parziale sulla base di:
     Infezioni;
     Qualità della cicatrice:
    o Cutometer® 3, 6, 12, 24 e 36 mesi dopo l'innesto;
    o DSM II ColorMeter® 3, 6, 12, 24 e 36 mesi dopo l'innesto;
    o Questionario POSAS 3, 6, 12, 24 e 36 mesi dopo l'innesto;
     % di epitelializzazione 4 settimane dopo l'innesto;
     Adesione dell'innesto 4-11 giorni dopo l'intervento;
     % di epitelializzazione per ogni visita dello studio (per effettuare una stima del "tempo necessario per la completa epitelializzazione");
     Grado di chiusura della ferita 8 e 12 settimane dopo l'innesto;
     Valutazione e notifica di tutti gli eventi avversi (previsti e imprevisti);
     Valutazione qualità della vita (questionari EQ-5D e BSHS-B);
     Utilizzo delle risorse del sistema sanitario (costi diretti per il sistema sanitario, tramite questionario non sottoposto ai pazienti).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Age: ≥18 years of age
     Deep partial thickness and/or full-thickness burns requiring
    surgical wound coverage
     The following two criteria must be met:
    - Expected that ≥90cm2 of wound (not counting the head
    and neck area for study patients in The Netherlands) will
    remain open at 4 weeks post burn despite proceeding with
    treatment in accordance with the standard of care,
    - >25% TBSA burn
     Signed Informed consent from the patient or the legally authorized
    representative.
     Età: ≥18 anni di età;
     Ustioni a spessore parziale e/o a spessore completo che richiedono una copertura della ferita per via chirurgica;
     Devono essere rispettati i seguenti due criteri:
    o Almeno 90 cm2 della ferita (non comprese le aree del capo e del collo per quanto riguarda i pazienti arruolati in Olanda) rimasti scoperti dopo 4 settimane dall'ustione nonostante siano stati sottoposti a trattamento secondo lo standard di cura;
    o Ustione che copre oltre il 25% della superficie corporea totale;
     Consenso informato firmato da parte del paziente o del legale rappresentante.
    E.4Principal exclusion criteria
     Patients tested positive for HBV, HCV, syphilis or HIV
     Patients with known underlying or concomitant medical conditions
    that may interfere with normal wound healing (e.g. systemic skin
    and connective tissue diseases, any kind of congenital defect of
    metabolism including insulin-dependent diabetes mellitus,
    Cushing syndrome or disease, scurvy, chronic hypothyroidism,
    congenital or acquired immunosuppressive condition, chronic
    renal failure, or chronic hepatic dysfunction (Child-Pugh class B or
    C), severe malnutrition, or other concomitant illness which, in the
    opinion of the Investigator, has the potential to significantly delay
    wound healing)
     Severe drug and alcohol abuse
     Pre-existing coagulation disorders as defined by INR outside its
    normal value, PTT >ULN and fibrinogen <LLN prior to the current
    hospital admission and / or at the Investigator’s discretion
     Patients allergic to amphotericin B and gentamicin
     Previous enrolment of the patient into the current phase II study
     Participation of the patient in another study with conflicting
    endpoints within 30 days preceding and during the present study
     Patients expected not to comply with the study protocol (including
    patients with severe cognitive dysfunction/impairment and severe
    psychiatric disorders)
     Pregnant or breast feeding females
     Intention to become pregnant during the clinical course of the
    study (12 months)
     Wounds in the head and neck area as study target area (only
    applicable for study patients in The Netherlands)
     Enrolment of the Investigator, his/her family members, employees
    and other dependent persons
     Pazienti positivi ai test per HBV, HCV, sifilide o HIV;
     Pazienti che presentano patologie pre-esistenti o concomitanti che potrebbero interferire con il normale processo di guarigione della ferita (es. malattie sistemiche della cute e dei tessuti connettivi, qualsiasi tipo di difetto congenito del metabolismo, compresi diabete mellito insulino-dipendente, sindrome o malattia di Cushing, scorbuto, ipotiroidismo cronico, immunodepressione congenita o acquisita, insufficienza renale cronica o insufficienza epatica cronica (Child-Pugh di classe B o C), malnutrizione grave, o altre infermità concomitanti che, nell'opinione del Ricercatore, possono potenzialmente provocare ritardi significativi nella guarigione della ferita);
     Grave abuso di alcool e droghe;
     Disturbi della coagulazione pre-esistenti, ovvero con INR fuori dal normale range di valori, PTT>ULN e fibrinogeno <LLN prima del ricovero ospedaliero e/o a discrezione del ricercatore;
     Pazienti allergici ad amfotericina B e gentamicina;
     Precedente partecipazione del paziente al presente studio di fase II;
     Partecipazione del paziente ad altro studio i cui endpoint siano in conflitto con quelli del presente studio nei 30 giorni precedenti questo studio, o nel corso dello stesso;
     Pazienti che non si ritiene siano in grado di rispettare il protocollo dello studio (compresi pazienti con gravi disabilità/disturbi cognitivi e gravi disturbi psichiatrici);
     Pazienti femmine in stato di gravidanza o in allattamento;
     Pazienti femmine con Intenzione di avviare una gravidanza nel corso dello studio clinico (12 mesi);
     Ferite nell'area del capo e del collo (soltanto per i pazienti arruolati in Olanda);
     Arruolamento del medico ricercatore, dei suoi familiari, dipendenti o altre persone correlate.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy evaluation, as a comparison between the EHSG-KF and control
    sites, based on:
     Ratio of covered surface area to biopsy site/donor site surface
    area
    Confronto tra EHSG-KF ed i siti di controllo per una valutazione dell'efficacia basata su:
     Rapporto tra superficie dell'area coperta e dimensioni della superficie del prelievo bioptico/sito donatore
    E.5.1.1Timepoint(s) of evaluation of this end point
    o visit 6 (28 +/-3 days post grafting)
    o visita 6 (28 +/- 3 giorni dopo l'innesto)
    E.5.2Secondary end point(s)
    Secondary Endpoints
    Safety and efficacy evaluation, as a comparison between the EHSG-KF
    and control sites, based on:
     Main secondary safety endpoint:
    Clinical and microbiologic signs of infection at
    o visits 4 (4-11 days post grafting)
    o visit 5 (21 +/-2 days post grafting)
     Main secondary efficacy endpoints:
    Scar quality at the study areas
    o Assessment of elasticity of the study areas using the
    Cutometer® at: visit 10 (1 year +/-30 days post grafting)
    o Assessment of general scar quality at the study areas
    using the POSAS, a reliable and validated scar assessment tool, at: visit 10 (1 year +/-30 days post
    grafting)
     Other secondary safety endpoint:
    Assessment and reporting of all adverse events (expected and
    unexpected) will be carried out for the full duration of the study.
     Other secondary efficacy endpoint:
    Epithelialization at:
    o visit 6 (28 +/-3 days post grafting)
    Exploratory Endpoints
     Graft take of the study areas assessed in a standardized manner
    as percentage of the whole grafted area during the first dressing
    change at:
    o visit 4 (4-11 days post grafting)
     % Epithelialization (to estimate time to complete epithelialization)
    at:
    o visit 5 (21 +/-2 days post grafting)
    o visit 7 (60 +/-3 days post grafting)
    o visit 8 (90 +/-5 days post grafting)
    o visit 9 (6months +/-10 days post grafting)
     Clinical and microbiologic signs of infection at:
    o visit 6 (28 +/-3 days post grafting)
     Incidence of wound closure at:
    o visit 7 (60 +/-3 days post grafting)
    o visit 8 (90 +/-5 days post grafting)
     Assessment of elasticity of the study areas using the Cutometer®
    at:
    o visit 8 (90 +/-5 days post grafting)
    o visit 9 (6 months +/-10 days post grafting)
    o visit 11 (2 years +/-30 days post grafting)
    o visit 12 (3 years +/-30 days post grafting)
     Assessment of general scar quality at the study areas using the
    POSAS, a reliable and validated scar assessment tool, at:
    o visits 8 (90 +/-5 days post grafting)
    o visit 9 (6 months +/-10 days post grafting)
    o visit 11 (2 years +/-30 days post grafting)
    o visit 12 (3 years +/-30 days post grafting)
     Assessment of colour (erythema and pigmentation) of the study
    areas using the DSM II ColorMeter® at:
    o visit 8 (90 +/-5 days post grafting)
    o visit 9 (6 months +/-10 days post grafting)
    o visit 10 (1 year +/-30 days post grafting)
    o visit 11 (2 years +/-30 days post grafting)
    o visit 12 (3 years +/-30 days post grafting)
     QOL assessment (EQ-5D and BSHS-B) at:
    o visit 8 (90 +/-5 days post grafting)
    o visit 9 (6 months +/-10 days post grafting)
    o visit 10 (1 year +/-30 days post grafting)
    o visit 11 (2 years +/-30 days post grafting)
    o visit 12 (3 years +/-30 days post grafting)
     Healthcare resource utilization (direct healthcare costs)
    Endpoint secondari:
    Confronto tra EHSG-KF ed i siti di controllo per una valutazione dell'efficacia e della sicurezza basata su:
     Endpoint secondario principale di sicurezza:
    Evidenze cliniche e microbiologiche di infezioni in occasione di:
    o visita 4 (4-11 giorni dopo l'innesto);
    o visita 5 (21 +/- 2 giorni dopo l'innesto);
     Endpoint secondari principali di efficacia:
    Qualità della cicatrice a livello delle porzioni cutanee studiate:
    o Valutazione dell'elasticità presso le porzioni cutanee studiate tramite Cutometer® alla visita 10 (1 anno +/-30 giorni dopo l'innesto);
    o Valutazione della qualità generale della cicatrice in corrispondenza delle porzioni cutanee studiate tramite POSAS, affidabile e testato strumento di valutazione delle cicatrici, alla visita 10 (1 anno +/-30 giorni dopo l'innesto);
     Endpoint secondario di sicurezza:
    Nel corso dell'intera durata dello studio verranno valutati e registrati tutti gli eventi avversi (previsti e imprevisti);
     Endpoint secondario di efficacia:
    Grado di epitelizzazione alla visita 6 (28 +/- 3 giorni dopo l'innesto);
    Endpoint esplorativi:
     Valutazione standardizzata del grado di adesione dell'innesto in corrispondenza delle porzioni cutanee studiate espressa come percentuale dell'intera area innestata, nel corso della prima sostituzione della medicazione, alla visita 4 (4-11 giorni dopo l'innesto);
     % di epitelializzazione (per effettuare una stima del "tempo necessario per la completa epitelializzazione"), con rilevamenti alle seguenti visite:
    o visita 5 (21 +/- 2 giorni dopo l'innesto);
    o visita 7 (60 +/- 3 giorni dopo l'innesto);
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
     Evidenze cliniche e microbiologiche di infezioni, con rilevamento alla visita 6 (28 +/- 3 giorni dopo l'innesto);
     Grado di chiusura della ferita, con rilevamenti alle seguenti visite:
    o visita 7 (60 +/- 3 giorni dopo l'innesto);
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
     Valutazione dell'elasticità delle porzioni cutanee studiate tramite Cutometer®, con rilevamenti alle seguenti visite:
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
    o visita 11 (2 anni +/- 30 giorni dopo l'innesto);
    o visita 12 (3 anni +/- 30 giorni dopo l'innesto);
     Valutazione della qualità generale della cicatrice in corrispondenza delle porzioni cutanee studiate tramite questionario POSAS, affidabile e testato strumento di valutazione delle cicatrici, con rilevamenti alle seguenti visite:
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
    o visita 11 (2 anni +/- 30 giorni dopo l'innesto);
    o visita 12 (3 anni +/- 30 giorni dopo l'innesto);
     Valutazione del colore (eritema e pigmentazione) delle porzioni cutanee studiate tramite DSM II ColorMeter®, con rilevamenti alle seguenti visite:
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
    o visita 10 (1 anno +/- 30 giorni dopo l'innesto);
    o visita 11 (2 anni +/- 30 giorni dopo l'innesto);
    o visita 12 (3 anni +/- 30 giorni dopo l'innesto);
     Valutazione della qualità della vita del paziente (questionari EQ-5D e BSHS-B), con rilevamenti alle seguenti visite:
    o visita 8 (90 +/- 5 giorni dopo l'innesto);
    o visita 9 (6 mesi +/- 10 giorni dopo l'innesto);
    o visita 10 (1 anno +/- 30 giorni dopo l'innesto);
    o visita 11 (2 anni +/- 30 giorni dopo l'innesto);
    o visita 12 (3 anni +/- 30 giorni dopo l'innesto);
     Utilizzo delle risorse del sistema sanitario (costi diretti per il sistema sanitario).
    E.5.2.1Timepoint(s) of evaluation of this end point
    See point E.5.2
    Rif. punto E.5.2
    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 No
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Intra-patient
    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
    standard gold standard treatment of burns
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Italy
    Netherlands
    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 years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with an altered state of consicousness
    Pazienti in stato alterato di coscienza
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 12
    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)
    None
    Nessuno.
    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 Decision2020-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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