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    Summary
    EudraCT Number:2019-002514-40
    Sponsor's Protocol Code Number:CISTA-TB
    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:2021-05-24
    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 number2019-002514-40
    A.3Full title of the trial
    Phase II study on the safety and efficacy of cysteamine in association with standard tuberculosis therapy for the treatment of patients with pulmonary tuberculosis: a new therapy for tuberculosis directed at the host
    Studio di fase II sulla sicurezza ed efficacia della cisteamina in associazione alla terapia tubercolare standard per il trattamento dei pazienti con tubercolosi polmonare: una nuova terapia per la tubercolosi diretta all’ ospite
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study on the safety and efficacy of cysteamine in association with standard tuberculosis therapy for the treatment of patients with pulmonary tuberculosis: a new therapy for tuberculosis directed at the host
    Studio di fase II sulla sicurezza ed efficacia della cisteamina in associazione alla terapia tubercolare standard per il trattamento dei pazienti con tubercolosi polmonare: una nuova terapia per la tubercolosi diretta all’ ospite
    A.3.2Name or abbreviated title of the trial where available
    CISTA-TB
    CISTA-TB
    A.4.1Sponsor's protocol code numberCISTA-TB
    A.5.4Other Identifiers
    Name:-Number:-
    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 SponsorISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    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 supportIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
    B.5.2Functional name of contact pointUO Ricerca Traslazionale
    B.5.3 Address:
    B.5.3.1Street AddressVia Portuense 292
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.4Telephone number0655170906
    B.5.5Fax number065582825
    B.5.6E-maildelia.goletti@inmi.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 CYSTAGON - 150 MG 100 CAPSULE FLACONE USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderRecordati Rare Disease
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/778
    D.3 Description of the IMP
    D.3.1Product nameCystagon
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Capsule, hard
    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 INN00191501
    D.3.9.1CAS number 60-23-1
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1950
    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 Yes
    D.3.11.13.1Other medicinal product typeAminoacidi e derivati.
    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
    Pulmonary Mycobacterium tuberculosis infection
    Infezione polmonare da Mycobacterium tuberculosis
    E.1.1.1Medical condition in easily understood language
    Pulmonary infection caused by Mycobacterium tuberculosis
    Infezione al pomone causata dal Micobatterio della tubercolosi
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037440
    E.1.2Term Pulmonary tuberculosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the safety and tolerability of cysteamine in adult patients with bacillifera pulmonary tuberculosis as adjunctive therapy to standard anti-tuberculosis treatment
    Valutare la sicurezza e la tollerabilità dell'uso della cisteamina nei pazienti adulti con tubercolosi polmonare bacillifera come terapia aggiuntiva al trattamento standard anti-tubercolare
    E.2.2Secondary objectives of the trial
    -Evaluate the efficacy of cysteamine through early bactericidal activity (EBA) through the use of culture from sputum at different time points (days -1, 7 and 14); the molecular assay for the assessment of bacterial load (MBLA) will be performed at the same time points as the EBA
    - Define the immunological and molecular bases of cysteamine activity;
    - Identify biomarkers useful for the monitoring of therapy in different biological samples (blood, plasma, serum, urine, sputum, saliva) at different time points [day 0, 7, 14, 28, 60, end of therapy (month 6) and month 18].
    -Valutare l’efficacia della cisteamina mediante early bactericidal activity (EBA) attraverso l’utilizzo della coltura dall’espettorato a diversi time points (giorno -1, 7 e 14); il saggio molecolare per la valutazione della carica batterica (MBLA) verrà effettuato agli stessi time points dell’EBA
    -Definire le basi immunologiche e molecolari dell’attività della cisteamina;
    -Identificare biomarcatori utili al monitoraggio della terapia in diversi campioni biologici (sangue, plasma, siero, urine, espettorato, saliva) a diversi time points [giorno 0, 7, 14, 28, 60, fine della terapia (mese 6) e mese 18]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age between 18 and 65;
    • Clinical signs and symptoms of pulmonary tuberculosis (new diagnosis)
    • Abnormal chest x-ray compatible with pulmonary tuberculosis
    • At least one positive sputum for acid-resistant bacteria (BAAR) (bacterisoscopic examen) [and molecular confirmation for M. tuberculosis by Xpert Mycobacterium tuberculosis (MTB) / rifampicin resistance (RIF) with a cycle threshold (Ct) <28.
    • Sensitivity to antituberculosis drugs by phenotypic pharmacosensitivity test on MGIT liquid medium
    • Weight =>50 kg
    • Karnofsky score of at least 60
    • Levels of leukocyte cystine (<2 nmol hemicystine / mg protein)
    • Ability to provide informed consent
    • Ability to adhere to control visits
    • Consent to be hospitalized for 4 weeks
    • Consent to perform a treatment under direct observation
    • Consent to comply with the following contraception requirements for people of childbearing age starting 2 weeks before enrollment at 18 weeks after the drug was administered:
    - Vasectomy with documented azoospermia for male subjects
    - Use of the condom for male subjects or one of the following contraceptive methods by the partner: Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal), Progestinal hormonal contraceptives associated with an ovulation inhibitor (oral, injectable, implantable), Intrauterine devices, Intrauterine devices with hormonal release system, Bilateral tubal binding, Partner's vasectomy,
    - Sexual abstinence;

    The infertility condition in female subjects will be defined:
    - In the pre-menopausal phase with: documented tubal closure; documented hysteroscopic tubal occlusion procedure, hysterectomy, documented ovariectomy
    - Post-menopausal phase: with 12 months of spontaneous amenorrhea and confirmation by hormonal dosage

    • Consent to carry out a pregnancy test before the administration of the experimental drug for female subjects of childbearing age
    • Età compresa tra i 18 e gli 65 anni;
    • Segni e sintomi clinici della tubercolosi polmonare (nuova diagnosi)
    • Radiografia anormale del torace compatibile con la tubercolosi polmonare
    • Almeno un espettorato positivo per batteri alchool-acido resistenti (BAAR) (esame batterisoscopico) [e conferma molecolare per M. tuberculosis da Xpert Mycobacterium tuberculosis (MTB)/resistenza a rifampicina (RIF) con una soglia di ciclo (Ct) <28.
    • Sensibilità ai farmaci antitubercolari mediante test di farmacosensibilità fenotipico su terreno liquido MGIT
    • Peso =>50 kg
    • Punteggio Karnofsky di almeno 60
    • Livelli di cistina leucocitaria (<2 nmol emicistina/mg di proteina)
    • Capacità di fornire il consenso informato
    • Capacità di aderire alle visite di controllo
    • Consenso ad essere ricoverato per 4 settimane
    • Consenso ad effettuare un trattamento sotto la diretta osservazione
    • Consenso ad attenersi ai seguenti requisiti di contraccezione per i soggetti in età fertile a partire da 2 settimane precedenti l’arruolamento a 18 settimane dopo la somministrazione del farmaco sperimentale:
    - Vasectomia con documentata azoospermia per i soggetti di sesso maschile
    - Utilizzo del condom per i soggetti di sesso maschile o uno dei seguenti metodi contraccettivi da parte della partner: Contraccettivi ormonali combinati associati ad inibitori dell’ovulazione (orali, intravaginali, transdermici), Contraccettivi ormonali progestinici associati ad un inibitore dell’ovulazione (orale, iniettabile, impiantabile), Dispositivi intrauterini, Dispositivi intrauterini con sistema di rilascio ormonale, Legatura tubarica bilaterale.
    - Astinenza eterosessuale
    La condizione di infertilità nei soggetti di sesso femminile verrà definita:
    - In fase pre-menopausa con: documentata chiusura delle tube; documentata procedura di occlusione tubarica isteroscopica, isterectomia, documentata ovariectomia
    - In fase post-menopausa: con 12 mesi di amenorrea spontanea e conferma mediante dosaggio ormonale

    • Consenso ad effettuare un test di gravidanza prima della somministrazione del farmaco sperimentale per i soggetti di sesso femminile in età fertile
    E.4Principal exclusion criteria
    • Age> 65 years and <18 years
    • Use of antiretroviral drugs
    • Hemoglobin concentration under 10 g / dl
    • Elevation of creatinine kinase at baseline more than three times the upper limit of normal
    • Abnormal baseline laboratory values ¿¿(baseline concentration of alanine aminotransferase (ALT) more than three times the upper limit of normal, serum creatinine concentration more than twice the upper limit of normal, total bilirubin serum level greater than twice the upper limit of normal, platelet count <100,000 / mm3, white blood cells (WBC) <2500 (mcL)
    • Pregnancy or breast-feeding
    • Silico-Tuberculosis
    • Previous anti-tuberculosis treatment or use for more than 5 days of anti-tuberculosis drugs in the 3 months prior to enrollment
    • Concomitant diseases or conditions for which anti-tuberculosis drugs are contraindicated. These include severe liver failure, acute arthritis, peripheral neuropathy
    • Presence of any physical or psychological condition which, according to the person responsible of the study, makes participation in the study inadvisable
    • Infection with an isolate known to be resistant to a first drug for tuberculosis, for example rifampicin
    • Scheduled or current use of cyclosporine, tacrolimus, erythromycin or colchicine
    • TB with extra-pulmonary localization
    • Therapy with immunosuppressive drugs and / or NSAIDs and / or cortisone drugs
    • TB resistant to first and second line drugs
    • Inability to understand and sign informed consent
    • Positivity for HIV, HCV, HBV (HBsAg positivity)
    • Hepatic impairment (Child A-C), Renal failure (creatinine clearance <50 ml / min), heart failure (NYHA III-IV), decompensated diabetes mellitus, neoplasms, ongoing neurological / psychiatric pathology (eg depression, psychotic crisis, suicide attempt), inflammatory bowel diseases or gastric ulcer / duodenal treatment, autoimmune diseases
    • Abuse of drugs / alcohol
    • Hypersensitivity to cysteamine or penicillin
    • Current use of cysteamine
    • Participation in other Clinical Trials
    • Età > 65 anni e <18 anni
    • Uso di farmaci antiretrovirali
    • Concentrazione di emoglobina inferiore a 10 g/dl
    • Elevazione della creatinina chinasi al basale più di tre volte il limite superiore del normale
    • Valori di laboratorio anormali al basale (concentrazione basale di alanina aminotransferasi (ALT) più di tre volte il limite superiore del normale, concentrazione di creatinina sierica più del doppio del limite superiore del normale, livello di bilirubina totale sierica maggiore del doppio del limite superiore del normale, conta piastrinica < 100.000 / mm3, globuli bianchi (WBC) <2500 (mcL)
    • Gravidanza o allattamento al seno
    • Silico-tubercolosi
    • Precedente trattamento anti-tubercolare o utilizzo per più di 5 giorni di farmaci anti-tubercolari nei 3 mesi precedenti all’arruolamento
    • Malattie concomitanti o condizioni per le quali i farmaci anti-tubercolari sono controindicati. Queste includono insufficienza epatica severa, artrite acuta, neuropatia periferica
    • Presenza di qualsiasi condizione fisica o psicologica che , secondo il responsabile dello studio, rende sconsigliata la partecipazione allo studio
    • Infezione con un isolato noto per essere resistente a un primo farmaco per tubercolosi, per esempio rifampicina
    • Uso programmato o corrente di ciclosporina, tacrolimus, eritromicina o colchicina
    • TB con localizzazione extra-polmonare
    • Terapia con farmaci immunosoppressori e/o FANS e/o cortisonici
    • TB resistente ai farmaci di prima e seconda linea
    • Incapacità a comprendere e firmare il consenso informato
    • Sieropositività per HIV, HCV, HBV (HBsAg positività)
    • Insufficienza epatica (Child A-C), Insufficienza renale (clearance della creatinina < 50 ml/min), insufficienza cardiaca (NYHA III-IV), diabete mellito scompensato, neoplasie, patologia neurologica/psichiatrica in atto (es. depressione, crisi psicotica, tentativo di suicidio), malattie infiammatorie croniche intestinali o ulcera gastrica/duodenale in trattamento, malattie autoimmuni
    • Abuso di droghe/alcol
    • Ipersensibilità a cisteamina o penicillina
    • Uso corrente di cisteamina
    • Partecipazione ad altri Trials Clinici
    E.5 End points
    E.5.1Primary end point(s)
    • Treatment acceptability.
    • Adherence: assumed doses / expected doses of cysteamine.
    • Treatment tolerance.
    • Pharmacokinetics of all administered drugs performed on plasma and urine.
    • Evaluation of serious adverse events (SAEs) and unexpected events
    • Correlation of possible AEs and SAEs with pharmacokinetic profiles.
    •Accettabilità del trattamento.
    •Aderenza: dosi assunte/dosi previste di cisteamina.
    •Tollerabilità del trattamento.
    •Farmacocinetica di tutti i farmaci somministrati effettuata su plasma e urine.
    •Valutazione degli eventi avversi gravi (SAE) e eventi inattesi:
    •Correlazione degli eventuali AE e SAE con i profili farmacocinetici.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • at each study visit --> treatment acceptability.
    • at each study visit --> adherence: assumed doses / expected doses of cysteamine.
    • at each study visit --> treatment tolerance.
    • at each study visit --> pharmacokinetics of all administered drugs performed on plasma and urine.
    • at each study visit --> evaluation of serious adverse events (SAEs) and unexpected events
    • at each study visit --> correlation of possible AEs and SAEs with pharmacokinetic profiles.
    • a ogni visita di studio --> accettabilità del trattamento
    • a ogni visita di studio --> aderenza: dosi assunte/dosi previste di cisteamina
    • a ogni visita di studio --> tollerabilità del trattamento
    • a ogni visita di studio --> farmacocinetica di tutti i farmaci somministrati effettuata su plasma e urine
    • a ogni visita di studio --> valutazione degli eventi avversi gravi (SAE) e eventi inattesi - a tutte le visite di studio
    • a ogni visita di studio --> correlazione degli eventuali AE e SAE con i profili farmacocinetici - a tutte le visite di studio
    E.5.2Secondary end point(s)
    • Evaluate the efficacy of cysteamine through early bactericidal activity (EBA) through the use of culture from sputum at different time points (day -1, 7 and 14); the molecular assay for the assessment of bacterial load (MBLA) will be performed at the same time points as the EBA.; • Evaluation of biomarkers useful for the monitoring of therapy in different biological samples (blood, plasma, serum, urine, sputum, saliva) at different time points [day 0, 7, 14, 28, 60, end of therapy (month 6)] ( in particular, cytokines / chemokines in plasma, sputum, saliva, urine by Luminex method or Ella will be evaluated
    • Immunological characterization of cysteamine activity. In particular, cell mononuclear markers, cytokine production and memory profile (CD3, CD4, CD8, CD19, CD45RA, CD27, CCR7 , CD38, CD25, HLA-DR, IFNg, TNFa, IL2) by flow cytometry; these results will be correlated with clinical, microbiological, radiological results.
    • Valutare l’efficacia della cisteamina mediante early bactericidal activity (EBA) attraverso l’utilizzo della coltura dall’espettorato a diversi time points (giorno -1, 7 e 14); il saggio molecolare per la valutazione della carica batterica (MBLA) verrà effettuato agli stessi time points dell’EBA.; • Valutazione di biomarcatori utili al monitoraggio della terapia in diversi campioni biologici (sangue, plasma, siero, urine, espettorato, saliva) a diversi time points [giorno 0, 7, 14, 28, 60, fine della terapia (mese 6)] (in particolare verranno valutate citochine/chemochine nel plasma, espettorato, saliva, urine mediante metodica Luminex o Ella
    • Caratterizzazione immunologica dell’attività della cisteamina. In particolare verranno valutati nelle cellule mononucleate isolate dal sangue periferico (PBMC) e stimolato con stimoli specifici per Mtb: marcatori di attivazione cellulare, la produzione di citochine e il profilo di memoria (CD3, CD4, CD8, CD19, CD45RA, CD27, CCR7, CD38, CD25, HLA-DR, IFNg, TNFa, IL2) mediante citometria a flusso; tali risultati verranno correlati con i risultati clinici, microbiologici, radiologici.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day -1, 7 and 14 --> evaluate the efficacy of cysteamine through early bactericidal activity (EBA) through the use of culture from sputum at different time points (day -1, 7 and 14); the molecular assay for the assessment of bacterial load (MBLA) will be performed at the same time points as the EBA.; day 0, 7, 14, 28, 60, end of therapy (month 6)]
    giorno -1, 7 e 14 --> valutare l’efficacia della cisteamina mediante early bactericidal activity (EBA) attraverso l’utilizzo della coltura dall’espettorato a diversi time points (giorno -1, 7 e 14); il saggio molecolare per la valutazione della carica batterica (MBLA) verrà effettuato agli stessi time points dell’EBA.; giorno 0, 7, 14, 28, 60, fine della terapia (mese 6)]
    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 No
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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
    The trial can be declared concluded after the clinical center has been closed.
    La sperimentazione potrà essere dichiarata conclusa dopo la chiusura del centro clinico.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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: 30
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    At the end of the study the patients will be followed at the institute and if necessary they will continue the treatments according to the normal clinical practice.
    Al termine dello studio i pazienti saranno seguiti presso l'istituto e se necessario continueranno i trattamenti secondo gli schemi previsti dalla normale 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 Decision2019-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-14
    P. End of Trial
    P.End of Trial StatusOngoing
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