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    Summary
    EudraCT Number:2019-002691-14
    Sponsor's Protocol Code Number:RC2019.1.6_ROSSI
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2019-002691-14
    A.3Full title of the trial
    VISCOUS BUDESONIDE IN PATIENTS AFFECTED BY EOSINOPHILIC ESOPHAGITIS, OPERATED FOR ESOPHAGEAL ATRESIA
    BUDESONIDE VISCOSA NEI PAZIENTI AFFETTI DA ESOFAGITE EOSINOFILA, OPERATI DI ATRESIA ESOFAGEA
    Studio di fase II/III non controllato sull’efficacia e la sicurezza della budesonide viscosa assunta per via orale da una popolazione di pazienti affetti da atresia esofagea ed esofagite eosinofila, per tre mesi. Studio EOS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oral viscous budesonide administration for 3 months in a population of patients affected by esophageal atresia and eosinophilic esophagitis.
    Somministrazione di Budesonide per via orale per 3 mesi in una popolazione di pazienti affetti da atresia esofagea e esofagite eosinofila
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberRC2019.1.6_ROSSI
    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 SponsorIRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
    B.1.3.4CountryItaly
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportC4C
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale Pediatrico Bambino Gesù
    B.5.2Functional name of contact pointCentro Trials
    B.5.3 Address:
    B.5.3.1Street AddressPiazza S.Onofrio 4
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00165
    B.5.3.4CountryItaly
    B.5.4Telephone number0668593081
    B.5.5Fax number0668593914
    B.5.6E-mailCTC@opbg.net
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBudesonide
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 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.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBudesonide
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.2Current sponsor codena
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 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.IMP: 3
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBudesonide
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBudesonide
    D.3.9.1CAS number 51333-22-3
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 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
    Eosinophilicesophagitis (EoE) in Esophageal atresia (EA).
    Atresia esofagea ed Esofagite eosinofila
    E.1.1.1Medical condition in easily understood language
    Eosinophilic esophagitis (EoE) in Esophageal atresia (EA).
    Atresia esofagea ed Esofagite eosinofila
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10064212
    E.1.2Term Eosinophilic oesophagitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is the study of efficacy during therapy with oral viscous budesonide, through evaluation of histological features ofesophageal mucosa before and after 3 months of therapy, in a group of patients between 1 month and 18 years old affected by EA with concomitant EoE. Intramucosal eosinophils < 15 eosinophils/HPF at the end of the therapeutic cycle will determine the efficacyof budesonide.
    L’obiettivo primario è lo studio dell’efficacia della terapia con budesonide viscosa assunta per via orale, attraverso la valutazione delle caratteristiche istologiche della mucosa esofagea prima e dopo tre mesi di terapia, in un gruppo dei pazienti di età compresa tra 1 mese e 18 anni affetti da AE (corretta chirurgicamente mediante anastomosi diretta esofago-esofagea) con concomitante EoE (diagnosi istologica:> 15 eosinofili/HPF in biopsie esofagee prossimali e distali). L’assenza di flogosi (eosinofili intramucosali < 15 eosinofili/HPF) al termine del ciclo terapeutico sarà segno di efficacia terapeutica del farmaco.
    E.2.2Secondary objectives of the trial
    Secondary objectives are clinical efficacy and safety evaluation after 3 months of therapy and after 3 months of follow-up, through assessment of clinical signs of esophagealstricture, number of relapses and quality of life of patients (dysphagia score) and adverse reactions to budesonide. The study will also assess the Pharmacokinetics (PK) of budesonide.
    Obiettivi secondari saranno l’efficacia clinica e la sicurezza dopo tre mesi di terapia, e dopo tre mesi di follow-up, attraverso la valutazione dei segni clinici di stenosi dell’esofago, del numero di recidive cliniche e della qualità di vita dei pazienti (score clinico disfagia), e del numero delle reazioni avverse al farmaco.
    Lo studio valuterà anche il profilo farmacocinetico del farmaco (PK).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Informed consent form of subjects fully capable of providing consent or parent/s, legal representative of minors according to the national law; assent in pre-pubertal (6-11 years) and (12-17 years).
    - Male/female subjects aged 31 month- =18 years
    -Patients operated for EA (direct anastomosis) with eosinophilic esophagitis, diagnosed histologically after endoscopy no more than 3 months before joining the trial and defined according to the most recent guidelines on EoE and according to Paediatric Gastrointestinal Endoscopy guidelines: 15 or more eosinophils per high- power field (0.3 mm2), as peak concentration in esophageal biopsy samples (at least 3 sites, with at least 1-2 biopsies from the proximal, medium and distal esophagus).
    -Potentially fertile patients (post-menarcal girls) must have a negative pregnancy test at screening before inclusion in the study
    - Consenso informato scritto dei soggetti legalmente abilitati a dare il consenso o il/i genitore / i / rappresentante legale dei minori secondo la legge nazionale; assenso in prepuberi. Soggetti di sesso maschile e/o femminile delle seguenti età: 3 anni1 mese -18 anni.- Pazienti operati per atresia esofagea (anastomosi diretta), con Esofagite eosinofila, diagnosticata endoscopicamente-istologicamente nei tre mesi che precedono l’ingresso nello studio, definita in accordo con i criteri basati sulle ultime linee guida sull’EoE (28) e sulle linee guida sull’Endoscopia Pediatrica Gastrointestinale (29): 15 o più Eosinofili per campo ad alto potere di definizione (0.3 mm2), come concentrazione di picco nei prelievi bioptici esofagei (almeno 3 siti, con almeno 1-2 biopsie in esofago prossimale, medio e distale).
    - Le pazienti potenzialmente fertili (ragazze in età post-menarcale) devono avere allo screening prima dell’inclusione nello studio, un test di gravidanza negativo
    E.4Principal exclusion criteria
    -Patients operated for esophageal atresia with jejunal or colonic interposition
    -Presence of concomitant esophago-gastrointestinal disorders
    - Weight less than 10 kg
    -Eosinophilia in other gastrointestinal tracts
    -Participation in other clinical trials
    - Allergic asthma and rhinitis during the month before the biopsy required for the study
    - Allergic reactions
    - Anticoagulant and immunomodulatory concomitant use
    - Topical/systemic steroids during the month before the biopsy required for the study
    - Hypersensitivity to the active substance, to any of the excipients
    - Inability or difficulty swallowing the drug
    - Chronic viral infections or immunodeficiency
    - Ongoing oropharyngeal candidiasis
    - Neurological development delay
    known cardiac, hepatic and renal disorders: condition of severe renal insufficiency at screening in terms of estimated GFR <30Ml / min / 1.73m ^ 2; liver failure in terms of ALT or AST> 3 × ULN and total Bilirubin> 1.7x ULN; heart failure (NYHA or Ross stage equal to or greater than 2)
    - Any laboratory abnormality which, in the opinion of the investigator, would make the patient unsuitable for the study.
    - If applicable, potentially fertile patients unable or unwilling to undergo pregnancy tests and to practice contraceptive measures from the time of informed consent up to 30 days after the last administration of the IMP
    - Pazienti operati per atresia esofagea con interposizione digiunale o colica
    - Presenza di altre malattie esofagogastrointestinali concomitanti
    - Eosinofilia in altri tratti gastrointestinali
    - Peso inferiore ai 10 kg
    - Partecipazione ad altri studi clinici sperimentali entro 30 giorni o 5 emivite di budesonide
    - Asma-rinite allergica nel mese che precede la biopsia di ingresso nello studio
    - Reazione allergiche o idiosincrasiche note agli steroidi
    - Concomitante uso di anticoagulanti, immunomodulatori
    - Steroidi topici/sistemici utilizzati nel mese precedente alla biopsia richiesta per l’ingresso nello studio
    - Ipersensibilità al principio attivo e/o agli eccipienti
    - Incapacità o difficoltà a deglutire il farmaco
    - Infezioni virali croniche o immunodeficit concomitanti
    - Candidiasi orofaringea in atto
    - Ritardo di sviluppo neurologico
    - Alterazioni cardiache, epatiche e renali note: condizione di grave insufficenza renale allo screening in termini di GFR stimata<30Ml/min/1,73m^2; insufficienza epatica in termini di ALT o AST >3×ULN e Bilirubina totale >1,7x ULN; insufficienza cardiaca (NYHA o Ross stage uguale o superiore a 2)
    - Qualsiasi anomalia di laboratorio che, a giudizio dello sperimentatore, renderebbe il paziente non idoneo per lo studio.
    - Se applicabile, pazienti potenzialmente fertili non in grado o non disposte a sottoporsi ai test di gravidanza e a praticare misure contraccettive dal momento del consenso informato fino a 30 giorni dopo l’ultima somministrazione dell’IMP
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of enrolled patients with histological response after 12 weeks of therapy. The histological responseis defined as the histological count of eosinophils/HPF. Patients will be classified as responders (0-14 eos/HPF), and non-responder (= 15 eos / HPF)
    - Percentuale di pazienti arruolati con risposta istologica dopo 12 settimane di terapia. La risposta istologica è definita dal conteggio istologico degli eosinofili per campo (EOS/HPF), sotto microscopia ottica (× 400). I pazienti verranno classificati in “responder” (0-14 eos / HPF), e “non responder” (= 15 eos / HPF).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks of therapy
    12 settimane di terapia
    E.5.2Secondary end point(s)
    -Percentageof patients in remission at 3 months and at 6 months according to PEESS 2.0 score.



    -Percentage of patients with histological response at 3 months according to the histological score of esophagitis.



    -Difference of EREFS score after 3 months of therapy (comparison of the score at screening and at end of study)in terms of average and standard deviation



    -Difference of clinical response according to PEESS 2.0 score at 3 months after the end of therapy and at 6 monthsof follow up versus baseline (comparison of score at screening and at end of study) in terms of average and standard deviation (SD).



    -Minimum plasmatic concentration(C through), maximum plasma concentration(C max), Time to maximum (Tmax) AndHalf Maximum (T1/2) Plasma Concentration, Area Under The Plasma Concentration-Time Curve (AUC) From Time Zero to Time of The Last Measurable Concentration (AUC0-last), according to a population PK model of viscous budesonide and cortisol, after 3 months of therapy, assessing if plasmatic concentrations are > (LOQ).



    - Difference of serum levels of morning cortisol and basal glucose versus baseline, at 3 months (end of therapy)and at 6 months of follow up, in terms of average and SD



    -Serious and non-serious adverse events (possibly oropharyngeal candidiasis) according to MedDRA as measure ofsafety and tolerability at 3 months and at 3 months of follow up.
    Percentuale di pazienti con risposta remissione clinica a 3 mesi e a 6 mesi secondo il sistema di punteggio PEESS 2.0 (36).
    Percentuale di pazienti con risposta istologica a 3 mesi secondo il sistema di punteggio istologico di esofagite (37).
    Differenza del punteggio endoscopico EREFS (Endoscopic Reference Score) dopo 3 mesi di trattamento con Budesonide Viscosa (confronto dello score allo screening e alla fine dello studio) in termini di media e DS.
    Differenza della risposta clinica secondo il punteggio PEESS (Pediatric Eosinophilic Esophagitis Symptom Scores v2.0) a 3 (fine della terapia) e 6 (follow-up) mesi versus baseline (confronto dello score allo screening e alla fine dello studio) in termini di media e DS.
    Concentrazioni plasmatiche minime (C trough), Maximum Plasma Concentration (Cmax), Time to Maximum (Tmax) And Half Maximum (T1/2) Plasma Concentration, Area Under The Plasma Concentration-Time Curve (AUC) From Time Zero to Time of The Last Measurable Concentration (AUC0-last), secondo un modello di PK di popolazione, della budesonide viscosa e del cortisolo, dopo tre mesi di terapia, valutando se le concentrazioni plasmatiche sono superiori al limite di quantificazione (LOQ).
    Differenza rispetto al baseline dei livelli sierici di cortisolo mattutino e glucosio basale, a 3 (fine della terapia) e 6 (follow-up) mesi in termini di media e DS.
    Eventi avversi seri e non seri classificati secondo la terminologia medica internazionale MedDRA come misura di sicurezza e tollerabilità a 3 mesi e dopo 3 mesi di follow-up. Eventi avversi di interesse speciale saranno candidiasi orofaringea (38), altre reazioni avverse potenzialmente associate ai corticosteroidi (es iperglicemia, ipertensione arteriosa).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see section secondary time points (time point is given under listed secondary end point).
    Si prega di far riferimento alla sezione specifica.
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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) No
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 2
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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
    Children
    MINORI
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 9
    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)
    Treatment or care after the subject has ended his/her participation in the trial will be the expected normal treatment of that condition according to standard of care.
    E' previsto il trattamento secondo pratica clinica.
    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 Decision2019-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
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