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    Summary
    EudraCT Number:2021-006454-30
    Sponsor's Protocol Code Number:23537
    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:2022-05-12
    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 number2021-006454-30
    A.3Full title of the trial
    Near-infrared molecular imaging for lung cancer detection and treatment during mini-invasive surgery (Phase II Trial)
    Imaging molecolare near-infrared nella localizzazione e trattamento del tumore del polmone in chirurgia miniinvasiva (Trial Di Fase II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Development of a fluorescent visualization system for non-visible lung cancer nodules
    Sviluppo di visualizzazione tramite fluorescenza per il trattamento chirurgico dei noduli polmonari tumorali non visibili
    A.3.2Name or abbreviated title of the trial where available
    RECOGNISE
    RECOGNISE
    A.4.1Sponsor's protocol code number23537
    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 SponsorDIPARTIMENTO DI SCIENZE CHIRURGICHE - UNIVERSITà DEGLI STUDI DI TORINO
    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 supportAIRC - Fondazione AIRC per la Ricerca sul Cancro
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Scienze Chirurgiche
    B.5.2Functional name of contact pointArea Servizi alla Ricerca
    B.5.3 Address:
    B.5.3.1Street AddressVia Santena, 7
    B.5.3.2Town/ cityTORINO
    B.5.3.3Post code10126
    B.5.3.4CountryItaly
    B.5.4Telephone number0116708362
    B.5.5Fax number0116708362
    B.5.6E-mailluca.cavallo@unito.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 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 nameCetuximab-800CW
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCetuximab-800CW
    D.3.9.2Current sponsor codeManufacturing Licence no. 108964 F
    D.3.9.3Other descriptive nameCetuximab-800CW is a fluorescent tracer composed of the monoclonal antibody cetuximab (Erbitux , Merck Europe BV) and the near-infrared fluorophore IRDye 800CW (LI-COR Bioscience). The antibody targets and binds to Epidermal Growth Factor Receptor (EGFR). Cetuximab is chimeric (mouse – human) antibody of the IgG1 isotype. IRDye 800CW is a dye with absorption and fluorescence peaks at 774 and 789nm, respectively. The investigational medicinal product supplied by the manufacturer is a sterile, end
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeCianina
    D.IMP: 2
    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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCetuximab
    D.3.2Product code [036584035]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.2Current sponsor code036584011
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    To date, lung resection and lymphadenectomy remains the best curative option in patients with early-stage non-small cell lung cancer. Moreover, cancer screening programs have led to a frequent diagnosis of indeterminate lung lesions, many of which require surgical biopsy for diagnosis and intervention. Additionally, pre-operative imaging assessment frequently underestimates lymph-node involvement. Finally, the increase in the utilization of minimally invasive procedure remains mandatory.
    La migliore strategia terapeutica in pazienti con neoplasie polmonari non a piccole cellule resta la resezione polmonare con linfoadenectomia. I programmi di screening, porteranno ad un maggiore tasso di diagnosi di noduli polmonari, molti dei quali richiedono una biopsia chirurgica per un corretto approccio terapeutico. Inoltre, le tecniche di imaging preoperatorie spesso sottostimano l’estensione linfonodale. Infine, lo standard terapeutico impone l’utilizzo della chirurgia miniinvasiva.
    E.1.1.1Medical condition in easily understood language
    The curative treatment of early-stage lung cancer is the miniinvasive surgical resection. Many tumors appear as little nodules deep in the lung, requiring a big thoracic incision to palpate them.
    La terapia del nodulo tumore singolo del polmone è la resezione chirurgica tramite piccole incisioni. Molti noduli sono piccoli e profondi e richiedono incisioni estese per consentirne la palpazione
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062042
    E.1.2Term Lung neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062042
    E.1.2Term Lung neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of our project is to verify if Cetuximab-IRDye800 could detect cancer nodules and lymph node metastases during minimally invasive thoracic surgery. A result in favor of the use of Cetuximab-IRDye800 would permit the use of a minimally invasive approach to a larger number of patients, which are presently operable only by a traditional “open” approach. Consequentially, it would lead to an improvement in surgical outcomes, a reduction of the costs, and an enhanced patients’ quality of life.
    Lo scopo del nostro progetto è verificare la possibilità di identificare durante procedure mini-invasive di chirurgia toracica (VATS) noduli polmonari neoplastici ed eventuali localizzazioni linfonodali tramite la somministrazione sistemica del composto Cetuximab-IRDye 800. Un risultato a favore dell’utilizzo di questo composto consentirebbe l’utilizzo di una terapia chirurgica con approccio mini-invasivo in una più ampia porzione di pazienti, i quali al momento sono considerati curabili unicamente tramite un approccio “open”. Una più ampia applicazione di interventi chirurgici mini-invasivi condurrebbe ad un globale miglioramento dei risultati perioperatori, ad una migliore qualità della vita dei pazienti sul lungo termine e, infine, ad una riduzione dei costi legati all’assistenza
    E.2.2Secondary objectives of the trial
    In addition, a result in favor of the use of Cetuximab-IRDye800 could consent to correctly remove mislead metastatic lymph-nodes (i.e. unexpected lymph-nodes metastasis) and neoplastic localization unidentified at pre-operative diagnostic assessments. It would lead to a more accurate cancer staging, a tailored post-operative treatment. Finally, we expect to validate the use of Cetuximab-IRDye800 as an optimal tracker that can be easily applied intraoperatively during minimally invasive surgical procedures.
    Lo scopo del nostro progetto è verificare la possibilità di identificare durante procedure mini-invasive di chirurgia toracica (VATS) noduli polmonari neoplastici ed eventuali localizzazioni linfonodali tramite la somministrazione sistemica del composto Cetuximab-IRDye 800. Un risultato a favore dell’utilizzo di questo composto consentirebbe l’utilizzo di una terapia chirurgica con approccio mini-invasivo in una più ampia porzione di pazienti, i quali al momento sono considerati curabili unicamente tramite un approccio “open”. Una più ampia applicazione di interventi chirurgici mini-invasivi condurrebbe ad un globale miglioramento dei risultati perioperatori, ad una migliore qualità della vita dei pazienti sul lungo termine e, infine, ad una riduzione dei costi legati all’assistenza.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinical Stage I non-small cell lung cancer (according to 8th Edition of TNM Staging System)
    - Considered candidate to minimally invasive surgical resection after pre-operative assessment (i.e. Thorax and abdomen CT scans, PET, respiratory function test) [26]
    - age =18 years
    - age <80 years,
    - Adequate organ function (bone marrow, renal, hepatic, cardiac)
    - PS (ECOG) =2
    - Written informed consent
    - neoplasie polmonari non a piccole cellule in primo stadio sec. 8a edizione TNM
    - paziente candidabile ad intervento chirurgico mini-invasivo sulla base della stadiazione preoperatoria (TC torace e addome, PET, prove di funzionalità respiratoria)
    - età =18 anni o <80 anni
    - adeguata funzionalità d’organo (emopoietico, renale, epatico, cardiovascolare)
    - adeguato performance status (ECOG =2)
    - acquisizione di consenso informato per la partecipazione allo studio
    E.4Principal exclusion criteria
    - Previous systemic treatments (e.g. chemotherapy, immunotherapy) for lung cancer
    - Previous radiotherapy on lung or mediastinum
    - Concomitant disorders that compromise the ability to adhere to the procedures of the Protocol
    - Hemoglobin < 9 gm/dL
    - Platelet count < 100,000/mm
    - Magnesium, potassium, and calcium < the lower limit of normal per institution normal lab values
    - Thyroid-stimulating hormone (TSH) < 13 micro international units/mL
    - Received an investigational drug within 30 days prior to the first dose of cetuximab IRDye800
    - Within 6 months prior to enrollment, myocardial infarction; cerebrovascular accident; uncontrolled congestive heart failure; significant liver disease; or unstable angina
    - History of infusion reactions to cetuximab or other monoclonal antibody therapies
    - Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
    - Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
    - Pregnant or breastfeeding
    - precedente trattamento sistemico per neoplasia polmonare (radioterapia, chemioterapia)
    - precedente radioterapia su polmone o mediastino
    - condizioni cliniche concomitanti tali da compromettere la possibilità di aderire al protocollo
    - emoglobina sierica <9 mg/dL
    - conta piastrinica < 100.000/mm3
    - valori sierici di magnesio, potassio e/o calcio inferiori ai limiti secondo i valori di riferimento del laboratorio istituzionale
    - TSH sierico < 13 microUI/mL
    - assunzione di farmaci oggetto di studio nei 30 giorni precedenti alla prima dose di Cetuximab-IRDye 800
    - anamnesi positiva per infarto del miocardio, eventi cerebrovascolari, scompenso cardiaco congestizio, epatopatia severa o angina instabile nei 6 mesi precedenti all’arruolamento nello studio
    - anamnesi positiva per reazioni all’infusione di cetuximab o altri anticorpi monoclonali
    - prolungamento del QT all’ECG preoperatorio (>440 ms per i soggetti di sesso maschile, >450 ms per i soggetti di sesso femminile)
    - terapia in corso con farmaci antiaritmici di classe IA (chinidina, procainamide) o di classe III (dofetilide, amiodarone, sotalolo)
    - stato di gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with detection of lung nodule during surgery by NIR camera, with respect to the pathology report.
    La percentuale di pazienti con noduli polmonari rilevabili intraoperatoriamente tramite l’utilizzo di telecamera a frequenze NIR, relativamente alla diagnosi istologica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline assessment will be performed within 28 days before starting protocol treatment, including: Medical history, concomitant medications, physical examination, vital signs (arterial pressure, pulse rate), height and weight, Performance Status, laboratory exams (complete blood count, renal and liver function tests, serum pregnancy test (in women of childbearing potential)), CT scan of the thorax and abdomen with contrast medium; PET scan; Other exams for tumor assessment as clinically indicated. During surgery, the number and location of fluorescent location in lung and mediastinum will be registered. The time between the activation of the NIR camera and the visualization of the expected lung nodule will be also registered.
    La valutazione primaria sarà eseguita entro 28 giorni dall’applicazione del protocollo e comprenderà: anamnesi, terapia farmacologica, esame obiettivo, parametri vitali (pressione arteriosa, frequenza cardiaca), peso e altezza, performance status, esami di laboratorio (esame emocromocitometrico, funzionalità epatica e renale, test di gravidanza per donne in età fertile); TC torace e addome con mezzo di contrasto; PET; altre indagini stadiative per la neoplasia primaria laddove clinicamente indicato. Durante l’intervento chirurgico, il numero e la localizzazione di focolai di fluorescenza a carico di parenchima polmonare e mediastino verrà registrato; sarà inoltre rilevato il tempo intercorrente tra l’attivazione della telecamera NIR e l’identificazione del nodulo polmonare bersaglio.
    E.5.2Secondary end point(s)
    - The proportion of patients with detection of lymph nodal metastatic disease during surgery by NIR camera, with respect to the pathology report.; - The proportion of patients with detection of unexpected cancer localization during surgery by NIR camera, with respect to the pathology report.; - The proportion of patients with negative surgical margins, with respect to the pathology report.; - Time spawn the insertion of the NIR camera and the visualization of the nodule. Localization of the fluorescent compound the known nodule will be annotated.; - Toxicity will be recorded and classified according to the definitions of the NCI criteria “Common Terminology Criteria for Adverse Events (CTCAE)”, version 5.0.
    - la percentuale di pazienti in cui si identificano intraoperatoriamente sospette localizzazioni linfonodali tramite l’utilizzo della telecamera a frequenze NIR e comparazione con l’esito dell’esame istologico; - la percentuale di pazienti in cui si identificano intraoperatoriamente sospette localizzazioni a carico di altri tessuti tramite l’utilizzo della telecamera a frequenze NIR e comparazione con l’esito dell’esame istologico; - la percentuale di pazienti con margini chirurgici negativi macroscopicamente e comparazione con l’esito dell’esame istologico; - tempo intercorrente tra l’attivazione della telecamera a frequenze NIR e l’identificazione/localizzazione del nodulo polmonare bersaglio; - eventi legati alla tossicità dovuti alla somministrazione del composto verranno registrati e classificati in accordo con le definizione nei criteri NCI “Common Terminology Criteria for Adverse Events (CTCAE)”, versione 5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    During surgery, the number and location of fluorescent location in lung and mediastinum will be registered. The time between the activation of the NIR camera and the visualization of the expected lung nodule will be also registered.
    Patients should be monitored for toxicity and compliance with a clinical assessment after each cetuximab and cetuximab-IRDye administration, including assessment of side effects, physical examination, and laboratory exams.; During surgery, the number and location of fluorescent location in lung and mediastinum will be registered. The time between the activation of the NIR camera and the visualization of the expected lung nodule will be also registered.
    Patients should be monitored for toxicity and compliance with a clinical assessment after each cetuximab and c
    Durante l’intervento chirurgico, il numero e la localizzazione di focolai di fluorescenza a carico di tessuto polmonare e/o mediastinico verrà registrato. Verrà inoltre registrato il tempo intercorrente tra l’attivazione della telecamera a frequenze NIR e la visualizzazione del nodulo polmonare bersaglio.
    I pazienti arruolati nello studio saranno monitorati per valutare la tolleranza alla somministrazione di Cetuximab-IRDye 800 e per individuare l’eventuale comparsa di fenomeni da tossicità, tramite la valutazione degli eventuali effetti avversi, l’esame obiettivo ed esami strumentali.; Durante l’intervento chirurgico, il numero e la localizzazione di focolai di fluorescenza a carico di tessuto polmonare e/o mediastinico verrà registrato. Verrà inoltre registrato il tempo intercorrente tr
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned 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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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 end of the protocol treatment, patients will be followed according to clinical practice.
    Al termine del protocollo di trattamento, i pazienti verranno sottoposti a trattamenti e controlli clinici in accordo con la usuale 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 Decision2023-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
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