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    Summary
    EudraCT Number:2018-001347-31
    Sponsor's Protocol Code Number:RF-2016-02361887
    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:2021-01-13
    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 number2018-001347-31
    A.3Full title of the trial
    Anti-nerve reactivity as predictor of response to
    immune therapy in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): A proof of concept study with rituximab in patients with CIDP not responding to conventional immune
    therapy
    Anti-nerve reactivity as predictor of response to
    immune therapy in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): A proof of concept study with rituximab in patients with CIDP not responding to conventional immune
    therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study with rituximab in patients with CIDP not responding to conventional immune therapy
    Studio pilota con rituximab in pazienti con CIDP non responsivi alla terapia immunologica convenzionale
    A.3.2Name or abbreviated title of the trial where available
    RF-2016-02361887
    RF-2016-02361887
    A.4.1Sponsor's protocol code numberRF-2016-02361887
    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 ISTITUTO CLINICO HUMANITAS
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Istituto Clinico Humanitas
    B.5.2Functional name of contact pointProf. Eduardo Nobile Orazio
    B.5.3 Address:
    B.5.3.1Street AddressVia Manzoni, 56
    B.5.3.2Town/ cityRozzano (MI)
    B.5.3.3Post code20089
    B.5.3.4CountryItaly
    B.5.4Telephone number0282242209
    B.5.5Fax number0282242298
    B.5.6E-maileduardo.nobile_orazio@humanitas.it
    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 MABTHERA - 1 FIALA 500 MG 50 ML
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRituximab
    D.3.2Product code
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRituximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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
    Chronic inflammatory demyelinating polyradiculoneuropathy
    Poliradicoloneuropatia cronica infiammatoria demielinizzante
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory demyelinating polyradiculoneuropathy
    Polineuropatia cronica infiammatoria demielinizzante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10072650
    E.1.2Term CIDP
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 efficacy and safety of rituximab in patients with CIDP not responsive to conventional
    immune therapies and to correlate the response to therapy with rituximab with the presence of
    antibody reactivities, and with CIDP clinical form (typical or atypical)
    Valutazione della efficacia e sicurezza del rituximab in uno studio esplorativo in aperto in pazienti con CIDP non responsivi alle terapie immunologiche convenzionali e correlazione della risposta alla terapia (miglioramento di un punto nel punteggio INCAT o due punti nel MRC sumscore o quattro punti nelle ROD) con la presenza degli anticorpi, la forma clinica della CIDP o delle sue varianti
    E.2.2Secondary objectives of the trial
    To identify the prevalence of different antibody reactivities to nerve antigens in a large population of
    Italian CIDP patients recruited in a Database, and to verify if the presence of these reactivities shows
    any association with the clinical and neurophysiologic phenotype, the severity of the neuropathy, and the response to the conventional therapy effective in CIDP including IVIg, steroids and plasma exchange.
    To create a databank of biomaterials (sera and CSF) with an associated dataset including the clinical and electrophysiological data, response to therapy and the results of antibody reactivities associated with CIDP to allow future immunological studies that may help understanding the pathogenesis of CIDP and the finding of biomarkers for disease activity or response to therapy.
    Identificazione della prevalenza delle reattivit¿ anticorpali contro antigeni del nervo, incluse la CNTN1, NF155, NF186, gliomedina, Caspr1, in una vasta casistica non selezionata di pazienti con CIDP reclutati nel database nazionale della CIDP e loro correlazione con il fenotipo clinico e neurofisiologico, la severit¿ della neuropatia e la risposta alle terapie immunologiche convenzionali (steroidi, IVIg, PE).
    Creazione di una banca dati di biomateriali (sieri e CSF) di pazienti con CIDP di cui siano disponibili i dati clinici, elettrofisiologici, e immunologici e la risposta alla terapia per consentire futuri studi su nuove reattivit¿ immunologiche che possano aiutare nella comprensione della patogenesi della malattia e nella identificazioni di biomarcatori di attivit¿ della malattia e di risposta alla terapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is = 18 years of age at Visit1 (screening) and who signed the informed consent form for the study.
    2. Subject has a documented diagnosis of definite or probable CIDP according to the EFNS/PNS criteria 2010 (Joint Task Force of the EFNS and the PNS, 2010).
    3. Subject has not improved after and adequate dose of therapy with intravenous immunoglobulins (IVIg) corresponding to at least 2 g/kg monthly for two months, steroids corresponding to the equivalent of at least 1 mg/kg daily of oral prednisone for two months or a course of at least 4 plasma exchanges within two weeks.
    4. Subject can take steroids at the maximum dosage equivalent to 12.5 mg/day of prednisone or 25 mg on alternate day or pulsed 400 mg/monthly of methylprednisolone as far as the dosage has been maintained stable (± 20%) in the previous 6 months.
    5. Female subjects of childbearing potential according with the Clinical Trial Facilitation Group - CTFG guidelines must have a negative serum pregnancy test and agree to use a highly effective method of birth control in accordance with the CTFG guidelines during the study and for a period of 12 months after their last dose of study drug.
    6. Male subject, when sexually active, with a partner of childbearing potential according with the CTFG guidelines must be willing to use a highly effective method of birth control in accordance with the CTFG recommendations during the study and for 12 months after the final administration of rituximab.
    1. Uomini e donne dell’età di almeno 18 anni all’inclusione che abbiamo firmato il consenso informato a partecipare allo studio.
    2. Pazienti con diagnosi di CIDP definita o probabile secondo i criteri della EFNS/PNS del 2010.
    3. Pazienti non responsivi ad almeno due terapie convenzionali efficaci nella CIDP effettuata a dosi adeguate quali immunoglobuline per via endovenosa (IVIg) ad almeno 2 g / kg al mese per due mesi, steroidi corrispondenti all'equivalente di almeno 1 mg / kg al giorno di prednisone orale per due mesi o un ciclo di almeno 4 scambi di plasma entro due settimane oppure pazienti non responsivi ad una terapia ma con controindicazioni ad effettuare un’altra di queste terapie.
    4. Il soggetto può assumere steroidi alla dose massima equivalente a 12,5 mg / die di prednisone o 25 mg a giorni alterni o 400 mg / mese di metilprednisolone endovena fin tanto che il dosaggio sia rimasto stabile (± 20%) nei 6 mesi precedenti.
    5. Donne in età fertile definita in accordo ai criteri della linea guida del Clinical Trial Facilitation Group - CTFG con un test di gravidanza negativo e che accettino di utilizzare un metodo di controllo delle nascite altamente efficace in accordo alle raccomandazioni della linea guida del CTFG durante lo studio e per un periodo di 12 mesi dopo l'ultima dose di farmaco in studio.
    6. Soggetti di sesso maschile sessualmente attivi e con una partner in età fertile definita in accordo ai criteri della linea guida del CTFG disposti a utilizzare un metodo di controllo delle nascite altamente efficace in accordo alle raccomandazioni della linea guida del CTFG durante lo studio e per 12 mesi dopo l'ultima dose di farmaco in studio.
    E.4Principal exclusion criteria
    1. Subject has a current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus
    2. Subject has IgM paraproteinemia with anti-myelin associated glycoprotein antibodies
    3. Subject has Multifocal Motor Neuropathy with conduction block (MMN)
    4. Clinical or known evidence of associated medical conditions that might cause neuropathy, including but not limited to connective tissue disease, Lyme disease, cancer (with the exclusion of benign skin cancer), Castleman’s disease and systemic lupus erythematosus, malignant plasma cell dyscrasia, lymphoma, osteosclerotic myeloma, POEMS, or assumption of agents that may lead to neuropathy (eg, amiodarone therapy).
    5. Female who is pregnant or lactating
    6. Subjects with any medical or psychiatric condition (acute or chronic) that, in the opinion of the investigator, could harm the subject or would compromise the subject’s ability to participate in the study.
    7. Subjects with congestive heart failure or a moderate or severe impairment of cardiac function
    8. Subjects with renal impairment defined as: serum creatinine > 1.4 mg/dL for females and 1.5 mg/dL for males
    9. Subjects with an absolute neutrophil count <4000/mm3, lymphocyte count <800/mm3, platelet count <100,000/mm3
    10. Subjects with liver impairment defined as total or conjugated bilirubin >1.5 × upper limit of the normal (ULN) range, unless in context of Gilbert’s syndrome; aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3 × ULN range; alkaline phosphatase (AP) >1.5 × ULN range; gamma-glutamyl-transferase (GGT) >3 × ULN range
    11. Subjects with a history of clinically relevant ongoing chronic infections including but not limited to human immunodeficiency virus (HIV), hepatitis B, hepatitis C, active or latent tuberculosis or is tested positive for HIV (anti-HIV1 or anti-HIV2 antibodies) hepatitis B (HBsAG positive or HBcAb positive without HBsAb) or hepatitis C (HCV antibodies) at the screening visit.
    12. Subject has a family history of primary immunodeficiency
    13. Subject has a clinically relevant active infection (eg. sepsis, pneumonia, and abscess) or has had a serious infection (resulting in hospitalization or parenteral antibiotic treatment) within 6 weeks prior to the first dose of rituximab.
    14. Subject has an active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix which has been definitely treated with standard of care approaches).
    15. Subject was treated with plasma exchange or immunoabsorption within 3 months of randomization, with immunosuppressive/chemotherapeutic medications including azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate within 6 months of randomization, other immunosuppressive medications (including mitoxantrone, alemtuzumab, cladribine, pimecrolimus , IPP-201101) at any time; total lymphoid irradiation or hematopoietic stem cell transplantation at any time; any biological therapy within 12 months of randomization.
    16. Subject has received a live vaccination within 8 weeks prior to the baseline visit or intends to have live vaccination during the course of the study or within 7 weeks following the final dose of rituximab.
    17. Subject has had prior treatment with rituximab in the 12 months before inclusion
    18. Subject is under anticoagulant drugs with the exception of low-dose heparin as preventive therapy
    19. History of hypersensitivity to Rituximab or to drugs of similar chemical classes.
    1. Diagnosi corrente o storia di diabete mellito di tipo 1 o 2
    2. Soggetti con gammopatia monoclonale IgM con anticorpi anti-MAG
    3. Soggetti con neuropatia motoria multifocale.
    4. Evidenza clinica o anamnestica di altre patologie che possano causare la neuropatia ivi incluse ma non limitate a malattie del connettivo, malattia di Lyme, neoplasia (con la esclusione di neoplasia benigne della cute), malattia di Castleman, lupus sistemico eritematoso, discrasia plasmacellulare maligna, linfoma, mieloma osteosclerotico, POEMS, o uso di sostanze che possano aver causato la neuropatia, quali amiodarone.
    5. Donne in gravidanza o in allattamento attivo o che pianificano una gravidanza durante il periodo dello studio
    6. Evidenza di altre patologie cliniche o psichiatriche che, a parere dell’esaminatore, possano interferire con la partecipazione del paziente allo studio o la valutazione della risposta alla terapia
    7. Paziente con scompenso cardiaco congestizio o con moderata o severa insufficienza cardiaca
    8. Paziente con insufficienza renale, definite come valori di creatininemia =1.4 mg/dL per le donne e =1.5 mg/dL per gli uomini.
    9. Pazienti con conta di leucociti <4000/mm3, linfociti < 800/mm3, e piastrine <80000/mm3
    10. Pazienti con compromissione epatica definita come valori di bilirubina coniugata > 1,5 i valori superiori della norma, se non nell’ambito di un ittero di Gilbert; aspartatoamino transferasi (AST) o alaninaamino transferasi (ALT) > 3 volte il limite superiore della norma, fosfatasi alcalina superiore a 1,5 i valori superiori della norma, gammaglutamiltransferasi (gammGT) >3 volte i limiti superiori della norma.
    11. Paziente con storia clinicamente rilevante di infezione cronica attiva ivi compreso ma non limitata a infezione da virus dell’immunodeficienza acquisita (HIV), epatite B, epatite C, tubercolosi attiva o latente, o positivi al test per HIV (anticorpi anti-HIV1 o anti-HIV2), epatite B (positività HBsAg o HBcAb senza positività per HBsAb), o epatite C (HCVAb) alla visita di screening.
    12. Pazienti con storia famigliare di immunodeficienza primaria
    13. Presenza di infezione attiva clinicamente rilevante alla inclusione (es. sepsi, polmonite, ascesso) o una importante infezione che ha richiesto la ospedalizzazione nei sei mesi precedenti.
    14. Paziente con neoplasia in atto o nei cinque anni precedenti escluse neoplasia locali della cute e della cervice uterine adeguatamente trattate
    15. Pazienti trattati con plasmaferesi o immuno assorbimento negli ultimi tre mesi, con immunosoppressori o chemioterapici inclusi azatioprina, ciclofosfamide, ciclosporina, micofenolato, etanercept, metotressato negli ultimi 6 mesi prima dello screening o altri immunosoppressore tra cui mitoxantrone, alemtuzumab, cladribina, pimecrolimus , IPP-201101 in qualsiasi momento, trapianto di cellule staminali o irradiazione totale linfoide in qualsiasi momento o con qualsiasi terapia biologica negli ultimi 12 mesi.
    16. Soggetti sottoposti a vaccinazione con vaccini viventi nelle 8 settimane precedenti lo screening o che intendano sottoporsi a vaccinazione con vaccini vivi nel corso dello studio o nelle 7 settimane successive all’ultima dose di rituximab placebo.
    17. Soggetti che abbiamo ricevuto il rituximab nei 12 mesi precedenti lo screening
    18. Soggetti in terapia anticoagulante esclusa terapia profilattica con basse dosi di eparina.
    19. Soggetti con ipersensibilità a qualsiasi dei prodotti usati nello studio o a farmaci di simile composizione chimica
    E.5 End points
    E.5.1Primary end point(s)

    The proportion of patients with CIDP not responsive to conventional immune therapies that
    improve 6 months after therapy with rituximab (at least one point on the INCAT scale or two points
    on the MRC force scale or four points on the RODs scale)
    Percentuale dei pazienti non responsivi alle terapie convenzionali che migliorano nei 6 mesi dopo la terapia con rituximab di almeno un punto della scala INCAT o di due punti della scala di forza MRC o di quattro punti della scala RODs
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    Proportion of patients with CIDP not responsive to conventional immune therapies that improve 12 months after therapy with rituximab (at least one point on the INCAT scale or two points on the MRC force scale or four points on the RODs scale).; Proportion of patients discontinuing treatment with rituximab due to side effects or voluntary withdrawal or developing these effects within 12 months following treatment.; Duration of clinical improvement (1 point on the INCAT scale or two points on the MRC force scale or four points on the RODs scale) after therapy with rituximab; Improvement of quality of life according to the SF-36 scale after 6 and 12 months from the start of treatment.; Proportion of patients that improve 6 and 12 months after therapy with rituximab in subgroups defined according to the CIDP clinical form (typical or atypical).; Proportion of patients not responsive to conventional therapies that improve 6 months and 12 months after rituximab therapy in electrophysiological parameters (at least 20% in motor conduction velocity, distal latency, distal and proximal CMAP amplitude in at least two nerves)
    Percentuale dei pazienti non responsivi alle terapie convenzionali che siano migliorati nei 12 mesi successivi alla terapia con rituximab di almeno un punto della scala INCAT o di due punti della scala di forza MRC o di quattro punti della scala RODs; Percentuale di pazienti che interrompono il trattamento con rituximab per effetti collaterali o per sospensione volontaria o che sviluppano tali effetti nei 12 mesi successivi al trattamento; Durata della risposta al trattamento (1 punto alla scala INCAT o due punti della scala di forza MRC o di quattro punti della scala RODs) dopo la terapia con rituximab; Miglioramento della qualit¿ della vita secondo la scala SF-36 dopo 6 e 12 mesi dall¿inizio del trattamento; Confronto della risposta alla terapia con rituximab a 6 e 12 mesi dall¿inizio del trattamento tra sottogruppi di pazienti definiti in base alla presenza di reattivit¿ anticorpali e alla forma clinica della CIDP; Percentuale dei pazienti non responsivi alle terapie convenzionali che siano migliorati 6 mesi e 12 mesi dopo la terapia con rituximab nei parametri elettrofisiologici (almeno del 20% in velocit¿ di conduzione motoria, latenza distale o ampiezza del CMAP distale o prossimale in almeno due nervi)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months; 12 months; Month 2, 4, 6, 8, 10 and 12; 6 and 12 months; 6 and 12 months; 6 and 12 months
    12 mesi; 12 mesi; Mese 2, 4, 6, 8, 10 e 12; 6 e 12 mesi; 6 e 12 mesi; 6 e 12 mesi
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA6
    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 years3
    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 years3
    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 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 will be followed and treated according to the local clinical practice
    I pazienti saranno seguiti e trattati in accordo alla pratica clinica locale
    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 Decision2018-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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