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    Summary
    EudraCT Number:2019-002221-29
    Sponsor's Protocol Code Number:VIT-2763-THAL-201
    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:2021-01-28
    Trial results View 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 number2019-002221-29
    A.3Full title of the trial
    A Phase 2a, Double-blind, Randomised, Placebo-controlled, Parallel Group, Multicentre Study on Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Multiple Doses of VIT-2763 in Subjects with Non-transfusion Dependent Beta-thalassaemia
    Studio di fase 2a, in doppio cieco, randomizzato, controllato con placebo, a gruppi paralleli, multicentrico, volto a valutare la sicurezza, la tollerabilità, la farmacocinetica, la farmacodinamica e l'efficacia preliminare di dosi multiple di VIT-2763 in soggetti affetti da beta-talassemia non trasfusione-dipendente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to the assess safety, tolerability and the effect of VIT-2763 on blood markers, symptoms and quality of life in patients with non-transfusion dependent beta-thalassemia
    Uno studio per valutare sicurezza, tollerabilità e gli effetti di VIT-2763 nei marcatori del sangue, sintomi e qualità della vita in pazienti affetti da talassemia non trasfusione-dipendente
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberVIT-2763-THAL-201
    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 SponsorVIFOR (INTERNATIONAL) INC.
    B.1.3.4CountrySwitzerland
    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 supportVifor (International) Inc.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVifor Pharma Management Ltd.
    B.5.2Functional name of contact pointCommunications
    B.5.3 Address:
    B.5.3.1Street AddressFlughofstrasse 61
    B.5.3.2Town/ cityGlattbrugg
    B.5.3.3Post codeCH-8152
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041588518000
    B.5.5Fax number0041588518001
    B.5.6E-mailinfo@viforpharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2170
    D.3 Description of the IMP
    D.3.1Product name-
    D.3.2Product code [VIT-2763]
    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.3.9.2Current sponsor codeVIT-2763
    D.3.9.4EV Substance CodeSUB190537
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-transfusion Dependent Beta-thalassaemia
    Beta-talassemia non-trasfusione dipendente
    E.1.1.1Medical condition in easily understood language
    Iron overload in the blood
    Eccessivo accumulo di sangue
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10074355
    E.1.2Term Non-transfusion dependent thalassaemia
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of VIT-2763 versus placebo in adult and adolescent NTDT subjects over a 12-week treatment period
    Valutare la sicurezza e la tollerabilità di VIT-2763 rispetto al placebo in soggetti adulti e adolescenti affetti da NTDT durante un periodo di trattamento di 12 settimane
    E.2.2Secondary objectives of the trial
    - To assess the preliminary efficacy of VIT-2763 versus placebo on iron markers in adult and adolescent NTDT subjects over a 12-week treatment period.
    - To evaluate the PK of VIT-2763 in adult and adolescent NTDT subjects over a 12-week treatment period (using a population PK approach)
    - Valutare l'efficacia preliminare di VIT-2763 rispetto al placebo su marcatori del ferro in soggetti adulti e adolescenti affetti da NTDT durante un periodo di trattamento di 12 settimane.
    - Valutare la PK di VIT-2763 in soggetti adulti e adolescenti affetti da NTDT durante un periodo di trattamento di 12 settimane (utilizzando un approccio PK della popolazione).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Documented diagnosis of NTDT, including a ß-thalassaemia intermedia-phenotype.
    2. NTDT is defined as subjects having received <5 units of red blood cells (RBCs) during the 24-week period prior to randomisation/first drug administration of VIT-2763 or placebo (Day 1; 1 unit is defined as 200 to 350 ml of transfused packedRBCs and last RBC transfusion must have been received =14 days prior to randomisation).
    Note: Subjects who are supposed to receive RBC transfusions after randomization in the Investigator's opinion, and according to local practise, and having received at least 1 dose of VIT-2763, may be considered to stay on study treatment for safety reasons, and in case there are no tolerability concerns. Subjects will be censored for secondary efficacy.
    3. Male and female adult NTDT subjects, 18-65 years of age inclusive (Cohort I only) at time of screening.
    4. Male and female adolescent NTDT subjects, 12-17 years of age inclusive (Cohort II only) at time of screening.
    5. Subjects must have a mean baseline Hb <=11 g/dl, based on 2 consecutive measurements =1 week apart within 6 weeks prior to randomisation/baseline, and obtained Hb values show less than 10% relative difference (and equal or less than 1.0 g/dl absolute change between the highest and lowest value) between at least 2 measurements.
    Note: If there is 1 retrospective Hb value available for the subject at maximum of 2 weeks prior to screening (Day -28), the Hb value can be taken into consideration. A subject not meeting this criterion would be excluded but can be rescreened at maximum 2 times at a later time point.
    1. Diagnosi documentata di NTDT, incluso un fenotipo di ß-talassemia intermedia.
    2. La NTDT è definita come soggetti che hanno ricevuto <5 unità di eritrociti (RBC) durante un periodo di 24 settimane che precede la randomizzazione/prima somministrazione del farmaco in studio, VIT-2763 o placebo (giorno 1; 1 unità è definita come 200-350 ml di RBC concentrati trasfusi e l'ultima trasfusione di RBC deve essere stata ricevuta =14 giorni prima della randomizzazione).
    Nota: per i soggetti, che si prevede debbano ricevere trasfusioni di RBC dopo la randomizzazione secondo il giudizio dello sperimentatore e la pratica locale e che hanno ricevuto almeno 1 dose di VIT-2763, si può prendere in considerazione che continuino ad assumere il trattamento in studio per ragioni di sicurezza e nel caso non vi siano problemi di tollerabilità. I soggetti saranno censurati per efficacia secondaria.
    3. Soggetti adulti, maschi e femmine, affetti da NTDT, di età compresa tra 18 e 65 anni al momento dello screening (solo coorte I).
    4. Soggetti adolescenti*, maschi e femmine, affetti da NTDT, di età compresa tra 12 e 17 anni al momento dello screening (solo coorte II).
    5. I soggetti devono presentare una Hb media al basale <=11 g/dl, basata su 2 misurazioni consecutive a =1 settimana di distanza nelle 6 settimane che precedono la randomizzazione/il basale, e i valori di Hb ottenuti devono mostrare una differenza relativa inferiore al 10% (e un cambiamento assoluto tra il valore massimo e quello minimo uguale o inferiore a 1,0 g/dl) tra almeno 2 misurazioni.
    Nota: qualora fosse disponibile un valore Hb retrospettivo per il soggetto al massimo 2 settimane prima dello screening (giorno -28), tale valore può essere preso in considerazione. Un soggetto che non soddisfa tale criterio sarà escluso, ma lo screening potrà essere ripetuto successivamente per un massimo di 2 volte.
    E.4Principal exclusion criteria
    1. Documented diagnosis of TDT, including a beta-thalassaemia major phenotype (including ß0/ß0, ß+/ß+, ß0/ß+ genotype), and mixed compound heterozygous for sickling phenotype variants such as Hb S/ß-thalassaemia, or transfusion dependent non-deletional Hb H disease (i.e., Hb constant spring) or Hb C disease.
    2. Subjects on concomitant ICT or subjects on prior ICT when discontinued less than 4 weeks prior randomisation. If ICT was discontinued >=4 weeks prior randomization the subject is eligible.
    3. ICT naïve subjects with serum ferritin <150 ng/ml and/or documented LIC =1 mg/g liver dry weight assessed through MRI, or subjects on prior
    ICT with serum ferritin <300 ng/ml and/or documented LIC <3 mg/g liver dry weight assessed through MRI.
    Note: if documented LIC MRI scans retrieved within 24 months prior to randomization are not available per local practice, serum ferritin will be used only to document iron overload status.
    4. Subjects with TSAT <30%.
    5. Subjects with documented LIC >15 mg/g liver dry weight assessed through MRI, or a documented myocardial T2* <20 ms, if available per local practice and retrieved within 24 months prior to randomization.
    6. Adult or adolescent subjects with body weight <40.0 kg or >100 kg at screening.
    7. Chronic liver disease and/or ALT, AST or GGT above 3-fold the ULN range at screening.
    Note: A subject fulfilling this criterion will be excluded but can be rescreened at a later time point (in order to fulfil eligibility, =2 values within =1 week should be assessed and be within eligibility limits).
    8. eGFR <30 ml/min/1.73 m2 (according to chronic kidney disease classification Stage 4 or higher), and/or significant albuminuria >30 mg/mmol. eGFR should be estimated according to Chronic Kidney Disease Epidemiology Collaboration formula (CKI-EPI) in adults, and Schwartz formula in adolescents.
    9. Newly diagnosed folate deficiency anaemia and/or Vitamin B12 megaloblastic anaemia. Subjects with known folate deficiency anaemia and/or Vitamin B12 megaloblastic anaemia who are on =12 weeks stable replacement therapy are eligible.
    Note: A subject fulfilling this criterion will be excluded but can be rescreened at a later time point.
    10. Any history or clinically important finding of cardiac disorders, such as clinically relevant cardiac arrhythmia, cardiomyopathy, coronary disease, valve disorder, or heart failure according to New York Heart Association classification 3-4.
    11. Subjects with history of partial or total splenectomy within 6 months prior to screening.
    1. Diagnosi documentata di talassemia trasfusione-dipendente (Transfusion Dependent Thalassaemia, TDT), inclusi un fenotipo di beta-talassemia major (compresi i genotipi ß0/ß0, ß+/ß+, ß0/ß+) ed eterozigoti composti misti per le varianti del fenotipo falciforme, come Hb S/ß-talassemia, o la malattia da Hb H con difetto non delezionale trasfusione-dipendente (cioè, emoglobina Constant Spring) o la malattia da Hb C.
    2. Soggetti in trattamento concomitante con terapia ferro-chelante (Iron Chelation Therapy, ICT) o in trattamento pregresso con ICT, interrotto meno di 4 settimane prima della randomizzazione. Nota: se l'ICT è stata interrotta >=4 settimane prima della randomizzazione, il soggetto è idoneo allo studio.
    3. Soggetti ICT naïve con ferritina sierica <150 ng/ml e/o LIC documentato =1 mg/g di peso secco, valutato mediante RM o soggetti in trattamento pregresso con ICT e con ferritina sierica <300 ng/ml e/o LIC documentato <3 mg/g peso secco misurato mediante RM.
    Nota: se le immagini RM che documentano LIC effettuate entro 24 mesi prima della randomizzazione non sono disponibili per pratica locale, la ferritina sierica verrà usata solo per documentare lo status di accumulo del ferro.
    4. Soggetti con TSAT <30%.
    5. Soggetti con LIC documentato >15 mg/g di peso secco valutato mediante RM o con T2* miocardico documentato (T2*) <20 ms, se disponibile per pratica locale e effettuata entro 24 mesi prima della randomizzazione.
    6. Soggetti adulti o adolescenti con peso corporeo <40,0 kg o >100 kg allo screening e/o alla randomizzazione.
    7. Epatopatia cronica e/o livello di alanina transaminasi (ALT), aspartato transaminasi (AST) o gamma-glutamil transpeptidasi (GGT) maggiore di 3 volte il limite superiore di normalità (ULN) allo screening.
    Nota: un soggetto che soddisfa questo criterio sarà escluso dallo studio, ma lo screening potrà essere ripetuto successivamente (affinché il soggetto soddisfi i criteri di idoneità, devono essere valutati =2 valori entro =1 settimana e questi devono rientrare nei limiti di idoneità).
    8. Velocità di filtrazione glomerulare stimata (eGFR) <30 ml/min/1,73 m2 (stadio 4 o superiore secondo la classificazione della malattia renale cronica) e/o albuminuria significativa >30 mg/mmol. eGFR deve essere valutata usando la formula di Chronic Kidney Disease Epidemiology Collaboration (CKI-EPI) negli adulti, e la formula di Schwartz negli adolescenti.
    9. Anemia da carenza di folati e/o anemia megaloblastica da carenza della vitamina B12 di recente diagnosi. I soggetti con anemia da carenza di folati e/o anemia megaloblastica da carenza della vitamina B12 nota in trattamento da =12 settimane con terapia sostitutiva stabile sono idonei.
    Nota: un soggetto che soddisfa questo criterio sarà escluso, ma lo screening potrà essere ripetuto successivamente.
    10. Qualsiasi anamnesi o riscontro clinicamente importante di disturbo cardiaco, quale aritmia cardiaca clinicamente significativa, cardiomiopatia, coronaropatia, valvulopatia o insufficienza cardiaca di classe 3-4 secondo la classificazione della New York Heart Association.
    11. Soggetti con storia di splenectomia parziale o totale entro 6 mesi precedenti allo screening.
    E.5 End points
    E.5.1Primary end point(s)
    • Reported or observed AEs: by SOC and PT (MedDRA coded term), by severity and relation to study product in each treatment group.
    • Reported or observed SAEs: by SOC and PT (MedDRA coded term), by severity and relation to study product in each treatment group.
    • Changes in vital signs (blood pressure, pulse rate, and respiratory rate), clinical laboratory safety tests (haematology, serum biochemistry,
    coagulation, and urinalysis), 12-lead ECG, and physical examination findings
    • Eventi avversi (AE) riportati o osservati: per classe di sistemi organici (SOC) o termine preferito (PT) (termine codificato del Medical Dictionary for Regulatory Activities, MedDRA), per gravità e correlazione con il farmaco in studio per ciascun gruppo di trattamento.
    • Eventi avversi gravi (SAE) riportati o osservati: per SOC e PT codificato del MedDRA, per gravità e correlazione con il farmaco in studio per ciascun gruppo di trattamento.
    • Cambiamenti dei parametri vitali (pressione sanguigna, frequenza cardiaca e frequenza respiratoria), test di laboratorio sulla sicurezza clinica (ematologia, biochimica del siero, coagulazione e analisi delle urine), ecocardiogramma (ECG) a 12 derivazioni e riscontri dell'esame obiettivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For AEs: The AE reporting period ends at the last study contact Visit 9/Week 16.
    For SAEs: The SAE reporting period lasts until 4 weeks (28+-4 days) following the last study drug administration.
    For Changes in vital signs: during the study and until Visit 8/Week 12
    Per EA: il periodo di notifica degli eventi avversi finisce all'ultimo contatto previsto nella visita 9/settimana 16.
    Per i EAS: il periodo di notifica degli eventi avversi seri dura fino a 4 settimane (giorni 28 +/- 4) a seguito dell'ultima somministrazione del farmaco di studio
    Per i cambiamenti nei segni vitali: durante tutto lo studio e fino alla visita 8/settimana 12
    E.5.2Secondary end point(s)
    • Assessment of iron parameters (total serum iron, serum ferritin, serum transferrin, unsaturated iron binding capacity, calculated TSAT, from baseline over a 12-week period (absolute and change from baseline)).
    • PK parameters: Individual estimates of Cmax, clearance, distribution volume, AUC will be obtained using a population PK approach in adult and adolescent subjects combined with suitable mathematical/statistical analysis, using nonlinear mixed-effects modelling. Sparse sampling for determination of VIT-2763 plasma concentration following multiple dosing will be obtained from pre-dose trough to 3 or 4 hours post-dose at selected study visits.
    • Valutazione dei parametri del ferro [ferro sierico totale, ferritina sierica, transferrina sierica, capacità legante del ferro insaturo, saturazione della transferrina calcolata (TSAT), dal basale per un periodo di 12 settimane (cambiamento assoluto e rispetto al basale)].
    • Parametri PK: un campionamento sporadico per la determinazione della concentrazione plasmatica di VIT-2763 dopo dosi multiple sarà eseguito da prima della dose fino a 3 o 4 ore dopo la dose nelle visite dello studio selezionate. Sarà applicato un approccio PK della popolazione in soggetti adulti e adolescenti per stimare i parametri PK [Cmax, clearance, volume di distribuzione, area sotto la curva (AUC)].
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Iron parameters: prior to first administration and over a 12-week period
    • PK parameters: Blood samples for the determination of VIT-2763 plasma concentrations (sparse sampling) are collected on Visit 3 and Visit 7 at pre-dose trough and at approximately 1 hour and 4 hours postdose, and on Visits 6 and 8 at pre-dose trough and approximately at 1 hour and 3 hours post-dose.
    - Parametri del ferro: prima della prima somministrazione e oltre al periodo di 12 settimane
    - Parametri PK: campioni di sangue per la determinazione delle concentrazioni plasmatiche di VIT-2763 (campionamento sparso) verranno raccolti alla Visita 3 e alla Visita 7 in pre-dose e approssimativamente 1 ora e 4 ore post-dose, e alla Visita 6 e Visita 8 in pre-dose e approssimativamente 1 ora e 3 ore post-dose
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Israel
    Lebanon
    Thailand
    Greece
    Italy
    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
    Last visit last patient
    Ultima visita dell'ultimo paziente
    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 months1
    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 months1
    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) 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) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 36
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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