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    Summary
    EudraCT Number:2021-003524-32
    Sponsor's Protocol Code Number:NEPHENTE
    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:2022-11-18
    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 number2021-003524-32
    A.3Full title of the trial
    Neoadjuvant pembrolizumab in high-risk thyroid cancers (NEPENTHE)
    Terapia neoadiuvante con pembrolizumab nei tumori della tiroide ad alto rischio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neoadjuvant pembrolizumab in high-risk thyroid cancers (NEPENTHE)
    Terapia neoadiuvante con pembrolizumab nei tumori della tiroide ad alto rischio
    A.3.2Name or abbreviated title of the trial where available
    NEPHENTE
    NEPHENTE
    A.4.1Sponsor's protocol code numberNEPHENTE
    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 SponsorIstituti Clinici Scientifici Maugeri SpA Società Benefit
    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 supportMERCK SHARP & DOHME
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICS Maugeri SpA SB
    B.5.2Functional name of contact pointUO Oncologia Traslazionale
    B.5.3 Address:
    B.5.3.1Street AddressVia Salvatore Maugeri 4
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number0382592929
    B.5.6E-maillauradeborah.locati@icsmaugeri.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 KEYTRUDA (pembrolizumab, MK3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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.3.4Pharmaceutical form Solution for 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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High-risk thyroid cancers
    Tumori della tiroide ad alto rischio
    E.1.1.1Medical condition in easily understood language
    High-risk thyroid cancers
    Tumori della tiroide ad alto rischio
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10029099
    E.1.2Term Neoplasm thyroid
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Activity of pembrolizumab as neoadjuvant treatment in high-risk TCs.
    Attività di pembrolizumab come trattamento neoadiuvante nei TC ad alto rischio.
    E.2.2Secondary objectives of the trial
    Translational Objective: Neoadjuvant pembrolizumab administration might reverse immunosuppresive behaviour of high-risk TCs. Pembrolizumab might rescue CD8+T exhausted cells, enhancing immunoresponse and reverting the immunosuppressive phenotype of high-risk TCs.
    Exploratory Objectives:
    - Investigation of pembrolizumab escape mechanisms: investigate the biological mechanisms of pembrolizumab resistance in non-responding patients.
    - Investigate if MRI radiomics features might predict pembrolizumab activity.
    - Evaluate whether the immune modifications induced by neoadjuvant pembrolizumab might increase the avidity/efficacy of post-operative RAI.
    - Assess the rate of thyroiditis and its effect on immune response.
    Obiettivo traslazionale: la somministrazione neoadiuvante di pembrolizumab potrebbe revertire il comportamento immunosoppressivo dei tumori della tiroide (TC) ad alto rischio. Pembrolizumab potrebbe riattivare le cellule T CD8+ esaurite, migliorando la risposta immunologica e modificando il fenotipo immunosoppressivo dei TC ad alto rischio.
    Obiettivi esplorativi:
    - Indagare sui meccanismi di evasione del pembrolizumab: indagare i meccanismi biologici della resistenza al pembrolizumab nei pazienti che non rispondono.
    - Indagare se le caratteristiche della radiomica RM potrebbero predire l'attività di pembrolizumab.
    - Valutare se le modifiche immunitarie indotte dal pembrolizumab neoadiuvante possano aumentare l'avidità/efficacia del RAI post-operatorio.
    - Valutare il tasso di tiroidite e il suo effetto sulla risposta immunitaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of differentiated thyroid carcinoma candidate to surgery not previously treated will be enrolled in this study.
    2. Patients with a risk > 20% for persistent/recurrent disease (Filetti S, 2019; Haughen BR 2017): primary tumor > 4 cm; multifocal papillary microcarcinoma with extra tumor extension (ETE) and known BRAF V600E mutation; clinical N1; gross ETE (macroscopic invasion of perithyroidal soft tissues); extranodal extension; expected incomplete tumour resection.
    3. Poorly differentiated carcinoma; Hurtle cell carcinoma.
    4. Patients with distant metastasis at diagnosis.
    5. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
    6. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
    7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
    8. Have adequate organ function as defined in the following table (Table 2) Specimens must be collected within 10 days prior to the start of study treatment.
    9. Male participants:
    A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months (e.g. 5 terminal half-lives for pembrolizumab and/or any active comparator/combination) after the last dose of study treatment and refrain from donating sperm during this period.
    10. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
    a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 4 months after the last dose of study treatment.
    11. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
    1. Saranno arruolati in questo studio partecipanti di sesso maschile/femminile di almeno 18 anni di età al momento della firma del consenso informato con diagnosi istologicamente confermata di carcinoma differenziato della tiroide candidato alla chirurgia e non precedentemente trattato.
    2. Pazienti con rischio > 20% di malattia persistente/ricorrente: tumore primitivo > 4 cm; microcarcinoma papillare multifocale con estensione extra tumorale (ETE) e mutazione BRAF V600E nota; N1 clinico; ETE macroscopica (invasione macroscopica dei tessuti molli peritiroidei); estensione extranodale; attesa resezione incompleta del tumore.
    3. Carcinoma scarsamente differenziato; Carcinoma a cellule Hurtle.
    4. Pazienti con metastasi a distanza alla diagnosi.
    5. Il partecipante (o il rappresentante legalmente riconosciuto, se applicabile) fornisce il consenso informato scritto per lo studio.
    6. Avere una malattia misurabile basata sui criteri RECIST 1.1. Le lesioni situate in un'area precedentemente irradiata sono considerate misurabili se è stata dimostrata la progressione in tali lesioni
    7. Avere un performance status ECOG (Eastern Cooperative Oncology Group) da 0 a 1. La valutazione di ECOG deve essere eseguita entro 7 giorni prima della data di assegnazione/randomizzazione.
    8. Avere un'adeguata funzione d'organo (Tabella 1);
    9. I campioni devono essere raccolti entro 10 giorni prima dell'inizio del trattamento dello studio.
    10. Il partecipante di sesso maschile deve accettare di usare un contraccettivo durante il periodo di trattamento e per almeno 6 mesi (ad es. 5 emivite terminali per pembrolizumab e/o qualsiasi comparatore/combinazione attiva) dopo l'ultima dose del trattamento in studio e astenersi dal donare sperma durante questo periodo.
    11. La partecipante di sesso femminile è idonea a partecipare se non è incinta, non sta allattando e se si verifica almeno una delle seguenti condizioni:
    a. Non è una donna potenzialmente fertile (WOCBP)
    OPPURE
    b. Una WOCBP che accetta di seguire le indicazioni contraccettive durante il periodo di trattamento e per almeno 4 mesi dopo l'ultima dose di trattamento dello studio.
    12. Aver fornito un campione di tessuto tumorale d’archivio o una nuova biopsia di una lesione tumorale non precedentemente irradiata. I blocchi di tessuto fissati in formalina e inclusi in paraffina (FFPE) sono preferiti ai vetrini. Le biopsie appena ottenute sono preferibili ai tessuti archiviati.
    E.4Principal exclusion criteria
    1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
    2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
    3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
    4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
    5. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.
    6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
    7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
    8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in-situ (eg, breast carcinoma or cervical cancer in situ that have undergone potentially curative therapy are not excluded).
    9. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
    10. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
    11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
    12. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
    13. Has an active infection requiring systemic therapy.
    14. Has a known history of Human Immunodeficiency Virus (HIV) infection.
    15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
    16. Has a known history of active TB (Bacillus Tuberculosis).
    17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
    18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    19. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
    20. Has had an allogenic tissue/solid organ transplant.
    1. Una WOCBP che ha un test di gravidanza sulle urine positivo entro 72 ore prima della randomizzazione. Se il test delle urine è positivo o non può essere confermato come negativo, sarà richiesto un test di gravidanza su siero.
    2. Ha ricevuto una precedente terapia con un agente anti-PD-1, anti-PD-L1 o anti PD L2 o con un agente diretto a un altro recettore dei linfociti T stimolatori o co-inibitori (ad es. CTLA-4, OX 40, CD137).
    3. Ha ricevuto una precedente terapia antitumorale sistemica inclusi agenti sperimentali entro 4 settimane prima della randomizzazione.
    4. Ha ricevuto una precedente radioterapia entro 2 settimane dall'inizio dell'intervento di studio. I partecipanti devono essersi ripresi da tutte le tossicità legate alle radiazioni, non devono aver richiesto trattamento con corticosteroidi e non devono aver avuto una polmonite da radiazioni. È consentito un washout di 1 settimana per le radiazioni palliative (=2 settimane di radioterapia) per le malattie non del sistema nervoso centrale (SNC).
    5. Ha ricevuto un vaccino vivo entro 30 giorni prima della prima dose del farmaco in studio. Esempi di vaccini vivi includono, ma non sono limitati a, i seguenti: morbillo, parotite, rosolia, varicella/zoster (varicella), febbre gialla, rabbia, Bacillus Calmette-Guérin (BCG) e vaccino contro il tifo. I vaccini contro l'influenza stagionale iniettivi sono generalmente vaccini con virus uccisi e sono consentiti; tuttavia, i vaccini antinfluenzali intranasali (es. FluMist®) sono vaccini vivi attenuati e non sono ammessi. È consentita la somministrazione di vaccini uccisi.
    6. Sta attualmente partecipando o ha partecipato a uno studio su un agente sperimentale o ha utilizzato un dispositivo sperimentale entro 4 settimane prima della prima dose dell'intervento in studio.
    7. Ha una diagnosi di immunodeficienza o sta ricevendo una terapia steroidea sistemica cronica (con dosi superiori a 10 mg al giorno di prednisone equivalente) o qualsiasi altra forma di terapia immunosoppressiva entro 7 giorni prima della prima dose del farmaco in studio.
    8. Ha una storia di un secondo tumore maligno, a meno che il trattamento potenzialmente curativo non sia stato completato senza evidenza di tumore per 2 anni. Il requisito di tempo non si applica ai partecipanti che sono stati sottoposti a resezione definitiva con successo per carcinoma basocellulare della pelle, carcinoma a cellule squamose della pelle, cancro superficiale della vescica, cancro cervicale in situ o altri tumori in situ (p. es., carcinoma mammario o cancro cervicale in situ che hanno subito una terapia potenzialmente curativa non sono escluse).
    9. Ha note metastasi attive al SNC e/o meningite carcinomatosa. I partecipanti con metastasi cerebrali precedentemente trattate possono partecipare a condizione che siano radiologicamente stabili, cioè senza evidenza di progressione per almeno 4 settimane mediante imaging ripetuto (da notare che l'imaging ripetuto deve essere eseguito durante lo screening dello studio), clinicamente stabile e senza necessità di trattamento steroideo per almeno 14 giorni prima della prima dose di intervento in studio.
    10. Presenta grave ipersensibilità (=Grado 3) al pembrolizumab e/o ad uno qualsiasi dei suoi eccipienti.
    11. Ha una malattia autoimmune attiva che ha richiesto un trattamento sistemico negli ultimi 2 anni (con l'uso di agenti modificanti la malattia, corticosteroidi o farmaci immunosoppressivi). La terapia sostitutiva (ad es. tiroxina, insulina o terapia sostitutiva fisiologica con corticosteroidi per l'insufficienza surrenalica o ipofisaria, ecc.) non è considerata una forma di trattamento sistemico ed è consentita.
    12. Ha una storia di polmonite/malattia polmonare interstiziale (non infettiva) che ha richiesto steroidi o ha una polmonite/malattia polmonare interstiziale in corso.
    13. Ha un'infezione attiva che richiede una terapia sistemica.
    14. Ha una storia nota di infezione da virus dell'immunodeficienza umana (HIV).
    15. Ha una storia nota di infezione da epatite B (definita come antigene di superficie dell'epatite B [HBsAg] reattivo) o nota infezione da virus dell'epatite C attiva (definita come HCV RNA rilevato).
    16. Ha una storia nota di TBC attiva (Bacillus Tuberculosis).
    17. Ha una storia o evidenza attuale di qualsiasi condizione, terapia o anomalia di laboratorio che potrebbe confondere i risultati dello studio, interferire con la partecipazione del partecipante per l'intera durata dello studio, o non è nel migliore interesse del partecipante, secondo il parere dello sperimentatore curante.
    18. Ha conosciuto disturbi psichiatrici o da abuso di sostanze che interferirebbero con i requisiti del trial.
    19. È incinta o sta allattando o prevede di concepire o generare figli entro la durata prevista dello studio, a partire dalla visita di screening fino a 120 giorni dopo l'ultima dose del trattamento di prova.
    20. Ha subito un trapianto allogenico di tessuto/organo solido.
    E.5 End points
    E.5.1Primary end point(s)
    Objective tumor response (CRs plus PRs) according to RECIST criteria 1.1 (experimental Arm). Near pathological complete remission (pCR) defined as the persistence of < 5 mm of residual tumor in surgical specimen and pCR rates will be analyzed. The impact of pembrolizumab on surgery (rate of complete resections; rate of surgery delay; rate of complications, etc) will be investigated.
    Risposta obiettiva del tumore (CR più PR) secondo i criteri RECIST 1.1 (braccio sperimentale). Verrà analizzata la remissione patologica quasi completa (pCR) definita come la persistenza di < 5 mm di tumore residuo nel campione chirurgico e le percentuali di pCR. Sarà studiato l'impatto di pembrolizumab sulla chirurgia (tasso di resezioni complete; tasso di ritardo dell'intervento chirurgico; tasso di complicanze, ecc.).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks (30 days ± 3 days) from the date of assignment for patients enrolled in arm A. Subsequent tumor imaging should be performed according to standard of care during follow-up
    6 settimane (30 giorni ±3 giorni) dalla data di assegnazione per i pazienti arruolati nel Braccio A. L'imaging successivo del tumore deve essere eseguito secondo lo standard di cura durante il follow-up
    E.5.2Secondary end point(s)
    Primary Translational Endpoint:
    To investigate the behavior of exhausted CD8+ T in response to pembrolizumab in TCs and the relationships between T cell clusters. To this aim, “spatial-transcriptomic” sequencing will be performed in tumor tissues and will be paired to single-cell maps at peripheral level.
    Enpoint Traslazionale Primario:
    Investigare il comportamento delle celllule T CD8+ esaurite nei TC e la relazione tra i cluster di cellule T. A questo scopo, il sequenziamento “spaziale-trascrittomico” sarà eseguito nei tessuti tumorali e sarà accoppiato a mappe unicellulari a livello periferico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before and after pembrolizumab
    Prima e dopo la somministrazione di pembrolizumab
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 trial2
    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 concerned5
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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)
    Patients will be treated according the local clinical practice
    I pazienti saranno trattati in accordo alla pratica clinica locale
    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 Decision2023-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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