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    Summary
    EudraCT Number:2020-005507-39
    Sponsor's Protocol Code Number:DICTAT-1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 number2020-005507-39
    A.3Full title of the trial
    DECIPHERING IL-1 MEDIATED INFLAMMATION FOR THE TARGETED TREATMENT OF DILATED CARDIOMYOPATHY.
    Svelare l’infiammazione mediata da interleuchina-1 per il trattamento mirato della cardiomiopatia dilatativa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Targeted therapy with anakinra for dilated cardiomyopathy: phase IIa randomized double blind monocentric clinical trial to evaluate the efficacy and safety of anakinra plus standard of care vs standard of care alone in the treatment of dilated cardiomyopathy.
    Terapia mirata della Cardiomiopatia Dilatativa Infiammatoria con Anakinra: studio in doppio cieco, di fase IIa, randomizzato, controllato verso placebo per valutare efficacia e sicurezza di anakinra in aggiunta a standard di cura rispetto allo standard di cura per il trattamento della cardiomiopatia dilatativa.
    A.3.2Name or abbreviated title of the trial where available
    DICTAT-1
    DICTAT-1
    A.4.1Sponsor's protocol code numberDICTAT-1
    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 SponsorOSPEDALE SAN RAFFAELE
    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 organisationOSPEDALE SAN RAFFAELE
    B.5.2Functional name of contact pointUNITA' di IMMUNOLOGIA, REUMATOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number3894209237
    B.5.5Fax number0226435157
    B.5.6E-maildeluca.giacomo@hsr.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 KINERET - "100 MG/0,67 ML SOLUZIONE INIETTABILE" USO SOTTOCUTANEO SIRINGA PRERIEMPITA 7 SIRINGHE PRERIEMPITE
    D.2.1.1.2Name of the Marketing Authorisation holderSWEDISH ORPHAN BIOVITRUM AB (PUBL)
    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 nameKINERET
    D.3.2Product code [KINERET]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.2Current sponsor codeKINERET
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inflammatory dilated cardiomyopathy
    cardiomiopatia dilatativa infiammatoria
    E.1.1.1Medical condition in easily understood language
    Dilation and dysfunction of the heart associated with inflammation of the myocardium, i.e. the "muscular tissue of the heart".
    Disfunzione e dilatazione del cuore da causa sconosciuta associata a infiammazione del tessuto muscolare del cuore.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10056419
    E.1.2Term Dilated cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007636
    E.1.2Term Cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10019280
    E.1.2Term Heart failures
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of IL-1 therapeutic blockade with Anakinra in improving Left Ventricular Ejection Fraction (LVEF) assessed by Trans Thoracic Echocardiograhy (TTE) at 4 weeks.
    Valutare l’efficacia di Anakinra in associazione alla terapia standard nel migliorare la frazione d’eiezione ventricolare sinistra (LVEF) valutata mediante ecocardiografia transtoracica (TTE) 4 settimane.
    E.2.2Secondary objectives of the trial
    1. To assess the efficacy of Anakinra in improving heart failure symptoms at 4 weeks (T1) and 12 weeks (T2).
    2. To assess the ability of Anakinra in improving the Total Quality Adjusted Life Year (QALYs) and patients reported outcomes at T1,T2
    3. To evaluate the efficacy of Anakinra in reducing venricular arrhythmias on 24h-ECG Holter at T1,T2
    4. To evaluate the efficacy of Anakinra in improving LVEF assessed by TTE at T2
    5. Changes in LV volumes and diameters on TTE at T1,T2
    6. To evaluate the efficacy of Anakinra in decreasing i-DCM-related hospitalization at T2
    7. To evaluate changes in NT-proBNP and high-sensitive troponin T serum levels at T1,T2
    8. To evaluate changes in C-reactive proteine (CRP), erythrocyte sedimentation rate (ESR), IL-1a, IL1RA, IL-1b, IL-6 and IL-18 serum levels at T1,T2
    9. To evaluate the safety of anakinra in the treatment of i-DCM at 4 different time points: baseline,T1, T2, and last follow-up (T3).
    Valutare l’efficacia di Anakinra nel migliorare i sintomi da scompenso cardiaco valutati mediante la classe NYHA a 4 settimane(T1) e 12 settimane(T2)
    Valutare l’efficacia di Anakinra nel migliorare la qualità di vita dei pazienti affetti da DCM con Patients Reported Outcomes e questionari di valutazione a T1,T2
    Valutare l’efficatia di Anakinra nel ridurre il burden aritmico a ECG-Holter 24h a T1,T2
    Valutare l’efficacia di Anakinra nel migliorare la LVEF valutata a T2 con TTE
    Valutare l’efficacia di Anakinra nel modificare i volumi e i diametri del ventricolo sinistro al TTE a T1,T2
    Valutare l’efficacia di Anakinra nel ridurre le ospedalizzazioni da DCM a T2
    Valutare l’efficacia di Anakinra nel ridurre i livelli sierici di NT-proBNP e troponina-T a T1,T2
    Valutare l’efficacia di Anakinra nel ridurre i livelli sierici di indici di flogosi sistemica e citochine pro-infiammatorie a T1,T2
    Valutare la sicurezza di Anakinra a 4 time points: baseline,T1,T2 e al termine del follow-up(T3)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age: 18 Years to 75 years;
    2. Diagnosis of DCM according to current guidelines;
    3. Symptoms of HF not improved or worsened despite at least 3 months of optimal therapy;
    4. LVEF<50% at echocardiography (TTE), not improved or worsened despite at least 3 months of optimal therapy;
    5. Increased high-sensitive troponin T (hs-TnT), and/or findings suggestive for actual or prior myocardial inflammation at cardiac MRI (within 6 months);
    6. Absence of coronary artery disease (coronary artery stenosis > 50% at angiography or coronary CT Scan, acceptable if performed during the last 12 months).
    7. Ability to sign an informed consent;
    8. Presence of CD3+ >7/mm2 cells on EMB, in addiction to all the aformentioned inclusion criteria, will be needed exclusively to be enrollend in the Phase IIa Randomized Double Blind monocentric Clinical Trial.
    1. Età tra i 18 e i 75 anni (sia maschi che femmine);
    2. Diagnosi di cardiomiopatia dilatativa (DCM) in accordo con le linee guida attuali e con presenza di CD3+ >7/mm2 alla biopsia endomiocardica (BEM);
    3. Sintomi di scompenso cardiaco peggiorati o non migliorati nonostante almeno 3 mesi di terapia medica ottimale;
    4. Compromissione della funzionalità contrattile del ventricolo sinistro definita come LV-EF <50% al TTE, non migliorata o peggiorata nonostante almeno 3 mesi di terapia medica ottimale;
    5. Rialzo dei livelli sierici di troponina T ad alta sensibilità (hs-TnT), e/o segni suggestivi di infiammazione miocardica attuale o pregressa alla CMR (nei 6 mesi precedenti);
    6. Assenza di patologia coronarica attiva (stenosi coronarica >50% in coronarografia o TC coronarica, eseguite nei precedenti 12 mesi)
    7. Capacità di firmare il consenso informato;
    8. Presenza di CD3+ >7/mm2 alla BEM, oltre a tutti i precedenti criteri di inclusione, necessaria esclusivamente per l'inclusione nello Studio pilota di fase IIa randomizzato, controllato vs placebo.
    E.4Principal exclusion criteria
    1. Genetic DCM;
    2. Toxin abuse/exposure (Alcohol, amphetamines, cocaine, anthracyclines [e.g., doxycycline], trastuzumab, clozapine, chloroquine, carbon monoxide, cobalt, lead, mercury;
    3. Clinical suspicion or proven underlying active, chronic or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or epatitis B virus (HBV) or hepatitis C virus (HCV) infection, Lyme disease, Chagas disease or any other bacterial/fungeal/protozoal disease possibly responsible for DCM;
    4. Endocrine, infiltrative (Cushing’s disease, acromegaly not clinically controlled hypo/hyperthyroidism, pheochromocytoma) or neuromuscular diseases (Dystrophinopathies [Duchenne/Becker muscular dystrophy/X-linked DCM], Limb-girdle muscular dystrophies, Facioscapulohumeral muscular dystrophy, Emery-Dreifuss muscular dystrophy, Friedreich’s ataxia, Myotonic dystrophy);
    5. Contraindications to EMB;
    6. Contraindications to PET/MRI (i.e. gadolinium hypersensitivity, renal failure, claustrophobia, pacemaker or ICD device, blood glucose>12.5 mmol/L);
    7. History of malignancy in the previous 5 years. Exceptions are basal cell skin cancer, carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy;
    8. Any other concomitant or previous biological anti-cytokine treatment administered within 5 -half lives of the specific drug;
    9. Renal failure as defined by estimated glomerular filtration rate (eGFR) <30 ml/min, according to Cockcroft-Gault;
    10. Hepatic impairment = Child-Pugh Class C;
    11. Mechanical ventilation circulatory assistance;
    12. Pregnancy, breastfeeding. Female patients of childbearing potential may participate if adequate contraception is used during the study. (For the purposes of this trial, women of childbearing potential are defined as “All female subjects after puberty unless they are post-menopausal for at least 2 years or are surgically sterile.”)
    13. Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients or to Escherichia coli-derived proteins).
    14. Presence of neutropenia < 1,5.109/L), or thrombocytopenia < 50.000/mm3;
    15. Any comorbidity limiting survival or conditions predicting inability to complete the study;
    16. Any concomitant immune-suppressive medications (i.e. azathioprine, methotrexate, cyclosporine, mycophenolate, cyclophosphamide, rituximab, tacrolimus);
    17. Therapy with prednisone >10 mg daily and/or any immuno-suppressive agents within 3 months before the enrolment;
    18. Congenital and/or acquired valvular disease or any other heart disease that could justify the severity of cardiac dysfunction;
    Major surgery within 2 weeks prior to randomization, or unhealed operation wounds.
    1. DCM genetica;
    2. DCM da esposizione/abuso di sostanze tossiche o farmaci
    3. Presenza o sospetto clinico di infezioni croniche, attive o ricorrenti batteriche, fungine, virali o protozoarie potenzialmente causa di DCM;
    4. Malattie endrocrine/infiltrative o neuromuscolari;
    5. Controindicazioni alla BEM;
    6. Controindicazioni alla PET/CMR (allergia a gadolinio, insufficienza renale, claustrofobia, pacemaker o ICD, glicemia >12.5 mmol/L);
    7. Storia di neoplasia nei 5 anni precedenti, eccetto basalioma cutaneo, carcinoma in situ della cervice e neoplasia prostatica a basso grado dopo intervento curativo;
    8. Qualsiasi trattamento con farmaci biologici/anti-citochine precedente (entro 5 –emivite dello specifico farmaco);
    9. Insufficienza renale terminale (Creatine Clearance (CrCl) < 30 ml/min calcolata con la Cockcroft-Gault];
    10. Insufficienza epatica terminale = Child-Pugh Class C;
    11. Ventilazione meccanica e supporto meccanico del circolo;
    12. Gravidanza, allattamento (le donne in età fertile possono partecipare utilizzando metodi contraccettivi efficaci durante tutto lo studio).
    13. Controindicazioni ad ANAKINRA (nota ipersensibilità al farmaco o agli eccipienti o a proteine derivate da Escherichia coli);
    14. Neutropenia severa (neutrofili <1,5.109/L), o trombocitopenia (50.000/mm3);
    15. Qualsiasi comorbidità che condizioni una ridotta sopravvivenza o condizione che predica un’inabilità a terminare lo studio;
    16. Qualsiasi altro trattamento immunosoppressivo concomitante;
    17. Terapia con prednisone >10 mg die e/o terapia immunosoppressiva nei 3 mesi precedenti;
    18. Patologie cardiache valvolari e/o congenite che possano giustificare la disfunzione cardiaca;
    Interventi di chirurgia maggiore nelle 2 settimane precedenti.
    E.5 End points
    E.5.1Primary end point(s)
    Improvement in left-ventricular function, based on the increase of left ventricular (LV) ejection fraction (EF) assessed by transthoracic echocardiography at 4-weeks.
    Valutazione dell’efficacia di ANAKINRA aggiunto allo standard of care su LVEF valutata mediante TTE a 4 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks
    4 settimane
    E.5.2Secondary end point(s)
    To evaluate the efficacy of Anakinra in improving LVEF assessed by Trans Thoracic Echocardiograhy (TTE) at 12 weeks (T2).; Changes in LV volumes and diameters on TTE at 4 weeks (T1) and 12 weeks (T2).; 1. To evaluate the efficacy of Anakinra in decreasing i-DCM-related hospitalization at 12 weeks (T2), by evaluating the number of days alive free of any DCM-related hospitalization at T2.; To evaluate changes in NT-proBNP serum levels at 4 weeks (T1) and 12 weeks (T2).; To evaluate changes in the high-sensitive troponin T serum levels at 4 weeks (T1) and 12 weeks (T2).; To evaluate changes in C-reactive proteine (CRP), erythrocyte sedimentation rate (ESR), IL-1alpha, IL1RA, IL-1beta, IL-6 and IL-18 serum levels at at 4 weeks (T1) and 12 weeks (T2).; To evaluate the safety of anakinra in the treatment of i-DCM at 4 different time points: baseline, 4 weeks (T1), 12 weeks (T2), and last follow-up (T3).; 1. To assess the efficacy of Anakinra in improving heart failure symptoms [New York Heart Association (NYHA) class] at 2 different time points: 4 weeks (T1) and 12 weeks (T2).; To assess the ability of Anakinra in improving the Total Quality Adjusted Life Year (QALYs) and patients reported outcomes (PROs) evaluated by Minnesota Living with SF36, Heart Failure and Kansas City Cardiomiopathy questionnaires at 4 weeks (T1) and 12 weeks (T2).; To evaluate the efficacy of Anakinra in reducing venricular arrhythmias (number of ventricular ectopic beats, runs of ventricular tachycardia) on 24h-ECG Holter at 4 weeks (T1) and 12 weeks (T2).
    Frazione d’eiezione ventricolare sinistra (LV-EF) valutata a 12 settimane (T2) mediante TTE.; Volumi e i diametri del ventricolo sinistro al TTE a 4 settimane (T1) e 12 settimane (T2).; Riduzione delle ospedalizzazioni da DCM a 12 settimane (T2).; Riduzione dei livelli sierici di NT-proBNP a 4 settimane (T1) e 12 settimane (T2).; Riduzione dei livelli sierici di troponina a 4 settimane (T1) e 12 settimane (T2).; Riduzione dei livelli sierici di indici di flogosi sistemica (VES, PCR, amiloide sierica A) e citochine pro-infiammatorie (IL-1alpha, IL1RA, IL-1beta, IL-6, IL-18, IL-18 BP e IL-37) a 4 settimane (T1) e 12 settimane (T2).; Numero di eventi avversi farmaco-relati e di AEs che richiedono sospensione farmagologica a 4 differenti time points: baseline, 4 settimane (T1), 12 settimane (T2) e al termine del follow-up (T3).; Sintomi da scompenso cardiaco mediante la classe funzionale New York Heart Association (NYHA) a 4 settimane (T1) e 12 settimane (T2).; Qualità di vita dei pazienti affetti da DCM mediante diversi PROs e questionari di valutazione a 4 settimane (T1) e 12 settimane (T2).; Burden aritmico valutato con ECG-Holter 24h a 4 settimane (T1) e 12 settimane (T2).
    Tempo/i di rilevazione di questo end point: 4 settimane e 12 settimane
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks; 4 weeks and 12 weeks; 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks; baseline, 4 weeks, 12 weeks and last follow-up; 4 weeks and 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks
    12 settimane; 4 settimane e 12 settimane; 12 settimane; 4 settimane e 12 settimane; 4 settimane e 12 settimane; 4 settimane e 12 settimane; baseline, 4 settimane, 12 settimane e ultima valutazione per ciascun paziente.; 4 settimane e 12 settimane; 4 settimane e 12 settimane; 4 settimane e 12 settimane
    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 No
    E.6.5Efficacy No
    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 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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months32
    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 months32
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    After the study completion, all patients will be followed-up according to current clinical practice as for best clinical practice, receiving all therapies necessary for their disease, according to current guidelines.
    Al termine della partecipazione allo studio, tutti i soggetti verranno seguiti come da pratica clinica corrente e riceveranno le terapie standard previste per la patologia da cui sono affetti in accordo con le linee guida.
    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 Decision2022-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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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