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    Summary
    EudraCT Number:2019-001599-12
    Sponsor's Protocol Code Number:ASC-Man-P016
    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:2021-06-17
    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 number2019-001599-12
    A.3Full title of the trial
    A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment
    Studio multicentrico in aperto per valutare la sicurezza e l'efficacia diagnostica del Mangoral in pazienti con lesioni epatiche focali note o sospette e grave insufficienza renale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and diagnostic Efficacy of Mangoral in Patients with abnormal liver cells and reduced kidney function
    Sicurezza ed efficacia diagnostica di Mangoral in pazienti con cellule epatiche anomale e ridotta funzionalità renale
    A.3.2Name or abbreviated title of the trial where available
    SPARKLE
    SPARKLE
    A.4.1Sponsor's protocol code numberASC-Man-P016
    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 SponsorAscelia Pharma AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAscelia Pharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAscelia Pharma AB
    B.5.2Functional name of contact pointMarie Källström
    B.5.3 Address:
    B.5.3.1Street AddressHyllie Boulevard 34
    B.5.3.2Town/ cityMalmö
    B.5.3.3Post code215 32
    B.5.3.4CountrySweden
    B.5.4Telephone number0046735179120
    B.5.6E-mailmk@ascelia.com
    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 nameMangoral
    D.3.2Product code [CMC-001]
    D.3.4Pharmaceutical form Oral powder
    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.3.9.1CAS number 13446-34-9
    D.3.9.2Current sponsor codeMangoral (CMC-001)
    D.3.9.4EV Substance CodeSUB27073
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number800
    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
    MRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairment
    Risonanza Magnetica in termini di visualizzazioni di lesioni epatiche focali in pazienti con lesioni epatiche focali note o sospette e grave insufficienza renale
    E.1.1.1Medical condition in easily understood language
    Magnetic resonance Imaging of the liver
    Risonanza Magnetica del fegato
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10028049
    E.1.2Term MRI
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the diagnostic efficacy of Mangoral in liver MRI in terms of visualization of detected focal liver lesions in combined MRI compared to unenhanced MRI. Lesion visualization will be determined by qualitative assessments of lesion border delineation and lesion contrast compared to background liver on 4-point scales for up to 15 lesions per patient.
    Valutare l'efficacia diagnostica del Mangoral nella Risonanza Magnetica (MRI) epatica in termini di visualizzazione di lesioni epatiche focali rilevate nella Risonanza Magnetica combinata rispetto alla MRI senza contrasto. La visualizzazione delle lesioni sarà determinata mediante valutazioni qualitative della delineazione dei margini delle lesioni e del contrasto delle lesioni rispetto allo sfondo epatico su scale a 4 punti per un massimo di 15 lesioni a paziente.
    E.2.2Secondary objectives of the trial
    To assess the diagnostic efficacy of Mangoral in liver MRI
    To evaluate the safety and tolerability of Mangoral;
    To evaluate the pharmacokinetics of manganese after a single dose of Mangoral in a subgroup of patients (including a small number of dialysis patients);
    To evaluate the impact of diagnostic performance of CMRI and Mangoral-enhanced MRI versus unenhanced MRI on the patients’ management.
    Valutare l'efficacia diagnostica di Mangoral nella MRI epatica
    Valutare la sicurezza e la tollerabilità di Mangoral;
    Valutare la farmacocinetica del manganese dopo una dose singola di Mangoral in un sottogruppo di pazienti (fra cui un piccolo numero di pazienti dializzati);
    Valutare l'impatto della performance diagnostica della CMRI e della MRI con contrasto Mangoral rispetto alla MRI senza contrasto sulla gestione dei pazienti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have been fully informed and have personally signed and dated the informed consent.
    2. Male and female patients 18 years and older.
    3. Patients who have known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations.
    4. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) measured within the screening period, or patients with an increase in serum creatinine = 0.3 mg/dL within 48 hours or = 50% within 7 days;
    5. Female patients who are not of childbearing potential, or female patients who are of childbearing potential but are using highly effective contraception (including hormonal contraceptives, such as combined oral contraceptives, patch, vaginal ring, injectables, and implants, intrauterine device, intrauterine hormone-releasing system, vasectomized partner, and tubal ligation) or practicing sexual abstinence (only accepted if this is the usual and preferred lifestyle of the patient), and have a negative urine or serum pregnancy test within 24 hours prior to administration of contrast agent.
    6. Sexually active male patients (who are not vasectomized) must be willing to use condoms after administration of Mangoral until the last follow-up visit.
    7. Patients who agree to comply with all study procedures as outlined within the study protocol and informed consent
    1. Pazienti che siano stati perfettamente informati e abbiano firmato e datato personalmente il consenso informato.
    2. Pazienti maschi e femmine dell'età minima di 18 anni.
    3. Pazienti affetti da lesioni epatiche focali note o sospette sulla base dell'anamnesi e di precedenti analisi di laboratorio e/o esami di imaging.
    4. Pazienti affetti da grave insufficienza renale (velocità di filtrazione glomerulare stimata [eGFR] < 30 mL/min/1,73 m2) misurata nel periodo di screening, o pazienti con un aumento della creatinina sierica = 0,3 mg/dL in 48 ore o = 50% in 7 giorni;
    5. Donne non potenzialmente fertili, o donne potenzialmente fertili, ma che utilizzano un sistema di contraccezione altamente efficace (che include contraccettivi ormonali, quali i contraccettivi combinati per via orale, cerotti, anelli vaginali, iniettabili e impianti, dispositivi intrauterini, sistemi intrauterini a rilascio di ormoni, partner vasectomizzato e legatura delle tube) o che praticano l'astinenza sessuale (accettate solo se questo è lo stile usuale e preferito della paziente) e che hanno effettuato un test di gravidanza negativo sull'urina o sul siero nelle 24 ore precedenti alla somministrazione del mezzo di contrasto.
    6. I pazienti maschi sessualmente attivi (non vasectomizzati) devono avere la volontà di usare preservativi dopo la somministrazione del Mangoral e fino alla visita di follow-up successiva.
    7. Pazienti che acconsentono a conformarsi a tutte le procedure dello studio delineate nel protocollo dello studio e nel consenso informato.
    E.4Principal exclusion criteria
    1. Patients who have received any investigational drug or were treated with an investigational device within 6 weeks prior to the Baseline Visit.
    2. Patients who have received any MRI contrast media within 6 weeks prior to Baseline Visit or are scheduled to receive any other contrast medium other than Mangoral before the last study visit.
    3. Patients who have previously been enrolled in the study and underwent Mangoral-enhanced MRI.
    4. Patients who are clinically unstable or have an acute illness; i.e. the underlying clinical condition is such that clinically relevant changes in condition can reasonably be anticipated during the study period.
    5. Patients with moderate or severe hepatic impairment (according to Child-Pugh score B or C).
    6. Patients currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis patients included in the PK subgroup.
    7. Patients scheduled for surgery before the last study visit.
    8. Pregnant or lactating women.
    9. Patient with history of severe allergies (e.g. anaphylaxis, respiratory difficulty).
    10. Patients with known hypersensitivity/previous allergic reactions, to manganese or any other compounds/excipients in Mangoral.
    11. Patients who are unable to comply with the study requirements including follow-up procedures.
    12. Patients with known portosystemic shunts.
    13. Patients with encephalopathy.
    14. Patients with neurodegenerative disorders.
    15. Patients with acute neurological disorders.
    16. Patients with hemochromatosis, iron deficiency anemia, or are on iron therapy within 14 days prior to the Baseline Visit.
    17. Patients receiving blood transfusion within 14 days prior to the Baseline Visit.
    18. Patients who cannot fast for 8 hours.
    19. Patients who cannot undergo MRI due to MRI incompatible pacemaker, metal implants, or other MRI contraindications.
    20. Patients with known inherited disorders of manganese metabolism.
    21. Patients with known pheochromocytoma.
    22. Patients with history of surgical/other interventional procedures or conditions which may interfere with absorption of Mangoral (e.g. small bowel obstruction, gastric bypass, gastric resection).
    23. Patients who have been institutionalized by official or court order and therefore are not completely free in their decision making process.
    24. Patients dependent on the sponsor, investigators, personnel of the trial site or any other individual, whose willingness to volunteer may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation.
    1. Pazienti a cui è stato somministrato un farmaco sperimentale o che sono stati trattati con un dispositivo sperimentale nelle 6 settimane precedenti alla visita di baseline.
    2. Pazienti a cui è stato somministrato un mezzo di contrasto per MRI nelle 6 settimane precedenti alla visita di baseline o per cui è stata programmata la somministrazione di un altro mezzo di contrasto diverso dal Mangoral prima dell'ultima visita dello studio.
    3. Pazienti che sono stati arruolati nello studio in precedenza e sono stati sottoposti a MRI con il mezzo di contrasto Mangoral.
    4. Pazienti clinicamente instabili o affetti da malattia acuta, ossia in cui la condizione clinica di base è tale che le variazioni clinicamente rilevanti della condizione possono essere ragionevolmente previste durante il periodo dello studio.
    5. Pazienti con insufficienza epatica moderata o grave (secondo la classificazione di Child-Pugh B o C).
    6. Pazienti che attualmente richiedono la dialisi o che probabilmente richiederanno la dialisi nel corso del trial clinico, eccetto i pazienti dializzati designati inclusi nel sottogruppo PK.
    7. Pazienti programmati per intervento chirurgico prima dell'ultima visita dello studio.
    8. Donne in gravidanza o allattamento.
    9. Pazienti con anamnesi di gravi allergie (ad es. anafilassi, difficoltà respiratoria).
    10. Pazienti con nota ipersensibilità/precedenti reazioni allergiche al manganese o altri composti/eccipienti contenuti nel Mangoral.
    11. Pazienti che non sono in grado di conformarsi ai requisiti dello studio, incluse le procedure di follow up.
    12. Pazienti con shunt porto-sistemici noti.
    13. Pazienti affetti da encefalopatia.
    14. Pazienti affetti da disturbi neurovegetativi.
    15. Pazienti affetti da disturbi neurologici acuti.
    16. Pazienti con emocromatosi, anemia sideropenica, o che seguono una terapia con ferro nei 14 giorni precedenti alla visita di baseline.
    17. Pazienti che ricevono una trasfusione di sangue nei 14 giorni precedenti la visita di baseline.
    18. Pazienti che non possono digiunare per 8 ore.
    19. Pazienti che non possono essere sottoposti a MRI a causa di pace-maker incompatibile con MRI, protesi metalliche o altre controindicazioni alla MRI.
    20. Pazienti con disturbi ereditari noti del metabolismo del manganese.
    21. Pazienti con feocromocitoma noto.
    22. Pazienti con anamnesi di procedure chirurgiche o altre procedure interventistiche o condizioni che potrebbero interferire con l'assorbimento del Mangoral (ad es. ostruzione dell'intestino tenue, bypass gastrico, resezione gastrica).
    23. Pazienti istituzionalizzati per ordinanza ufficiale o per ingiunzione e che pertanto non sono completamente liberi nel loro processo decisionale.
    24. Pazienti dipendenti dallo sponsor, ricercatori, personale del centro di sperimentazione o altre persone la cui volontà di proporsi come volontari potrebbe essere influenzata indebitamente dalla speranza, giustificata o no, di vantaggi associati alla partecipazione.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the visualization of detected focal liver lesions in combined MRI (CMRI, Mangoral-enhanced MRI plus unenhanced MRI) as compared to unenhanced MRI.
    Efficiency will be accessed by testing the superiority of each of the 2 coprimary variables:
    - lesion border delineartion (BD) and
    - lesion contrast compered to liver background (LC)
    L'endpoint primario dell'efficacia diagnostica sarà la visualizzazione di lesioni epatiche focali rilevate nella MRI combinata (CMRI, MRI con contrasto con Mangoral più MRI senza contrasto) rispetto alla MRI senza contrasto.
    L'efficienza sarà valutata testando la superiorità di ciascuna delle 2 variabili co-primarie:
    - la delineazione dei margini delle lesioni (BD) e
    - il contrasto delle lesioni rispetto al fegato di background
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessments will be done during central reading sessions.
    All unenhanced and Mangoral-enhanced MRI image sets will be evaluated centrally at the imaging core lab by 3 independent readers. The central evaluation of all MRI images will be consisted of 3 parts:
    - Part I: unenhanced MRI alone
    - Part II: combined MRI, i.e. paired reading of both unenhanced and Mangoral-enhanced images.
    - Part III: Mangoral-enhanced MRI alone.
    Each of the 3 independent readers will assess all images of all patients in each part of the reading. There will be a 2 weeks gap between read parts to reduce recall bias
    The analysis of the primary efficacy variable will be based on the quantitative assessments performed centrally at the imaging core lab.
    Le valutazioni saranno eseguite in modo centralizzato durante le sessioni di lettura.
    I set con le immagini di MRI vengono valutate centralmente nel laboratorio di imaging da 3 esaminatori indipendenti. La valutazione centralizzata è composta da 3 parti:
    - 1° parte: le immagini della MRI senza contrasto
    - 2° parte: le immagini della MRI combinata, ossia la lettura accoppiata di entrambi MRI con contrasto con Mangoral e senza)
    - 3° parte: le immagini della MRI con Mangoral
    Ognuno dei 3 esaminatori indipendenti valuterà tutte le immagini di tutti i pazienti in ciascuna parte della lettura. Ci sarà un intervallo di 2 settimane tra le parti della lettura per ridurre il bias di richiamo.
    E.5.2Secondary end point(s)
    - Number of lesions detected by each MRI method: unenhanced MRI, Mangoral-enhanced MRI, and CMRI
    - Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced-MRI
    - Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI and CMRI.
    - Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI and CMRI.
    - Lesion dimensions
    - Quantitative assessments
    - Change(s) in patients’ management based on diagnostic performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI
    - Numero di lesioni rilevato da ciascuno dei metodi di MRI (MRI senza contrasto, MRI con Mangoral e MRI combinata)
    - Visualizzazione di lesioni epatiche focali rilevate nella MRI con Mangoral rispetto alla MRI senza contrasto
    - Confidenza nell'individuazione delle lesioni separatamente nella MRI senza contrasto, MRI con Mangoral e MRI combinata;
    - Confidenza nella localizzazione delle lesioni separatamente nella MRI senza contrasto, MRI con Mangoral e MRI combinata
    - Dimensioni delle lesioni
    - Valutazioni quantitative
    - Variazione(i) nella gestione dei pazienti in base alla perfomance diagnostica della MRI combinata o della MRI con Mangoral rispetto alla MRI senza contrasto
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments will be done during central reading sessions as described in E.5.1.1.
    Additionally on-site evaluation will be done by each site investigator (or on-site radiologist) at the respective study site and will include separate assessments of all unenhanced and Mangoral-enhanced images of each patient. Data of on-site assessments will be used for analysis of specific secondary efficacy variables.
    In addition, brain MRI images will be evaluated by the independent off-site radiologist. Offsite evaluation should be performed within 5-working days after the respective MRI examination.
    Le valutazioni saranno eseguite in modo centralizzato durante le sessioni di lettura come descritto in E.5.1.1.
    Inoltre, la valutazione in loco verrà effettuata da ciascuno sperimentatore del centro (o radiologo in loco) nel proprio centro sperimentale, e includerà le valutazioni separate delle immagini della MRI con Mangoral e senza di ciascun paziente. I dati delle valutazioni in loco verranno utilizzati per l'analisi di specifiche variabili secondarie di efficacia.
    Inoltre, le immagini di MRI cerebrali verranno valutate da un indipendente radiologo off-site. Queste off-site valutazioni saranno eseguite entro 5 giorni lavorativi dopo il rispettivo esame di MRI.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Valutazione centralizzata da 3 examinatori indipendenti
    Central evaluation by 3 indipendent readers
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    Turkey
    United States
    France
    Germany
    Italy
    Poland
    Sweden
    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 months12
    E.8.9.1In the Member State concerned days36
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days36
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 97
    F.4.2.2In the whole clinical trial 197
    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 - Upon completion of the trial, patients should be treated at the discretion of the treating physician
    Nessuno - Al termine della sperimentazione i pazienti verranno trattati a discrezione del medico curante
    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 Decision2020-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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