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    Summary
    EudraCT Number:2020-005028-13
    Sponsor's Protocol Code Number:MK-6482-015
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 number2020-005028-13
    A.3Full title of the trial
    A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, formerly PT2977) Monotherapy in Participants with Advanced Pheochromocytoma/Paraganglioma (PPGL) or Pancreatic Neuroendocrine Tumor (pNET).
    Studio di Fase 2 per Valutare l’Efficacia e la Sicurezza di Belzutifan (MK 6482, precedentemente PT2977) in Monoterapia in Partecipanti con Feocromocitoma/Paraganglioma (PPGL) Avanzato o Tumore Neuroendocrino Pancreatico (pNET).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 study of Belzutifan (MK-6482) monotherapy in participants with Advanced Pheochromocytoma/Paraganglioma (PPGL) or Pancreatic Neuroendocrine Tumor (pNET).
    Studio di fase 2 con Belzutifan (MK-6482) in monoterapia in partecipanti con feocromocitoma/paraganglioma avanzato (PPGL) o tumore neuroendocrino pancreatico (pNET).
    A.3.2Name or abbreviated title of the trial where available
    Belzutifan/MK-6482 for the treatment of PPGL or pNET
    Belzutifan/MK-6482 per il trattamento di PPGL o pNET
    A.4.1Sponsor's protocol code numberMK-6482-015
    A.5.4Other Identifiers
    Name:INDNumber:153,091
    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 SponsorMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia S.r.l.
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano, 151
    B.5.3.2Town/ cityRoma (RM)
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number00390636191371
    B.5.5Fax number00390636380371
    B.5.6E-mailgcto.italy@merck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBelzutifan
    D.3.2Product code [MK-6482]
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INNBelzutifan
    D.3.9.2Current sponsor codeMK-6482
    D.3.9.4EV Substance CodeSUB207909
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pheochromocytoma/Paraganglioma or Pancreatic Neuroendocrine Tumor.
    Feocromocitoma/Paraganglioma o tumore neuroendocrino pancreatico.
    E.1.1.1Medical condition in easily understood language
    Pheochromocytoma, Paraganglioma or Pancreatic Neuroendocrine Tumors.
    Feocromocitoma/Paraganglioma o tumore neuroendocrino pancreatico.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10034876
    E.1.2Term Pheochromocytoma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10073860
    E.1.2Term Paraganglioma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10067518
    E.1.2Term Pancreatic neuroendocrine tumor
    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
    To evaluate the objective response rate (ORR) of belzutifan/MK-6482 per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
    Valutare l’ORR di belzutifan/MK-6482 secondo i criteri RECIST 1.1 mediante revisione centrale indipendente in cieco
    (BICR).
    E.2.2Secondary objectives of the trial
    1. To evaluate the duration of response (DOR) of belzutifan/MK-6482 in participants with a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 by BICR.
    2. To evaluate the time to response (TTR) of belzutifan/MK-6482 in participants with a confirmed CR or PR per RECIST 1.1 by BICR.
    3. To evaluate disease control rate (DCR) of belzutifan/MK-6482 per RECIST 1.1 by BICR.
    4. To evaluate progression-free survival (PFS) per RECIST 1.1 by BICR in participants receiving belzutifan/MK-6482.
    5. To evaluate the overall survival (OS) of participants receiving belzutifan/MK-6482.
    6. To evaluate the safety of belzutifan/MK-6482.
    1. Valutare la durata della risposta (DOR) di belzutifan/MK-6482 nei partecipanti con CR o PR confermata secondo i criteri RECIST 1.1 mediante BICR.
    2. Valutare il tempo alla risposta (TTR) di belzutifan/MK-6482 nei partecipanti con CR o PR confermata secondo i criteri RECIST 1.1 mediante BICR.
    3. Valutare il tasso di controllo della malattia (DCR) di belzutifan/MK-6482 secondo i criteri RECIST 1.1 mediante
    BICR.
    4. Valutare la PFS secondo i criteri RECIST 1.1 mediante BICR nei partecipanti riceventi belzutifan/MK-6482.
    5. Valutare la sopravvivenza globale (OS) dei partecipanti riceventi belzutifan/MK-6482.
    6. Valutare la sicurezza di belzutifan/MK-6482.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort A1: Pheochromocytoma/Paraganglioma (PPGL):
    1. Has documented histopathological diagnosis (local report) of pheochromocytoma or paraganglioma.
    2. Has locally advanced or metastatic disease that is not amenable to surgery or curative intent treatment.
    3. Adequately controlled blood pressure defined as blood pressure = 150/90 mm Hg (=135/85 mm Hg for adolescents) and with no change in hypertension) for at least 2 weeks prior to start of study treatment.

    Cohort A2: Pancreatic Neuroendocrine Tumor (pNET):
    4. Has documented histopathological or cytopathological diagnosis (local report) of well-differentiated, low or intermediate grade (G1 or G2 pNET per 2017 WHO classification and grading) pNET.
    5. Has locally advanced disease or metastatic disease that is:
    a) Not amenable for surgery, radiation, locoregional therapies or combination modality of such treatments with curative intent.
    b) Experienced disease progression on or after at least 1 line of prior systemic therapy that includes an approved targeted agent such as everolimus (mTOR inhibitor) or sunitinib (antiVEGF targeted agent). Participants who have received >3 prior systemic therapies will be capped to =20% of the cohort.

    Cohorts A1 and A2:
    6. Has disease progression within the past 12 months from screening.
    7. Has measurable disease per RECIST v1.1 by CT or MRI as assessed by local site investigator/radiology assessment and verified in real time by BICR. BICR must confirm the presence of radiologically measurable
    disease per RECIST 1.1 for the participant to be eligible for the study
    a) Irradiated lesions or lesions treated with locoregional therapies should not be used as target lesions unless they clearly demonstrate growth since completion of radiation.
    b) Metastatic lesions situated in the brain are not considered measurable and should be considered nontarget lesions.
    c) Only lesions of the primary indication for the cohort may be evaluated for measurability; other neoplastic lesions will be documented by the investigator and this information provided to the independent reviewers
    to ensure that such lesions are not included in the RECIST assessment.
    8. Is male or female, 12 years of age inclusive (=40 kg for adolescents [12-17 years of age]), at the time of signing the informed consent.

    For further inclusion criteria please refer to the protocol.
    Coorte A1: Feocromocitoma/paraganglioma (PPGL):
    1. Ha una diagnosi istopatologica documentata (report locale) di feocromocitoma o paraganglioma.
    2. Ha una malattia localmente avanzata o metastatica non idonea all’intervento chirurgico o al trattamento curativo.
    3. Ha una pressione arteriosa adeguatamente controllata definita come pressione arteriosa =150/90 mm Hg (=135/85 mm Hg per gli adolescenti) senza variazione nei farmaci antipertensivi (per i partecipanti con ipertensione concomitante) per almeno 2 settimane prima dell’inizio del trattamento sperimentale.

    Coorte A2: Tumore neuroendocrino pancreatico (pNET):
    4. Ha una diagnosi istopatologica o citopatologica documentata (report locale) di pNET ben differenziato, di grado basso o intermedio (pNET G1 o G2 secondo la classificazione e il grading OMS 2017).
    5. Ha una malattia localmente avanzata o una malattia metastatica con le seguenti caratteristiche:
    a) Non idoneità a chirurgia, radiazioni, terapie locoregionali o modalità di combinazione di tali trattamenti con intento curativo.
    b) Progressione della malattia durante o dopo almeno 1 linea di terapia sistemica precedente che include un agente mirato approvato come everolimus (mTOR inibitore) o sunitinib (agente mirato anti VEGF). I partecipanti che hanno ricevuto >3 terapie sistemiche precedenti saranno limitati a =20% della coorte.

    Coorti A1 e A2:
    6. Ha avuto una progressione della malattia nei 12 mesi precedenti allo screening.
    7. Ha una malattia misurabile con i criteri RECIST v1.1 tramite TC o RM secondo la valutazione dello sperimentatore/radiologo del centro e verificata in tempo reale dalla BICR. Affinché il partecipante sia eleggibile per lo studio, la BICR deve confermare la presenza di malattia radiologicamente misurabile con i criteri RECIST 1.1.
    a) Le lesioni irradiate o le lesioni trattate con terapie locoregionali non devono essere usate come lesioni target a meno che non dimostrino chiaramente una crescita dopo il completamento delle radiazioni.
    b) Le lesioni metastatiche localizzate nel cervello non sono ritenute misurabili e devono essere considerate lesioni non target.
    c) Solo le lesioni dell’indicazione primaria per la coorte possono essere valutate per la misurabilità; altre lesioni neoplastiche saranno documentate dallo sperimentatore e questi dati saranno forniti ai revisori indipendenti per assicurare che tali lesioni non siano incluse nella valutazione RECIST. Vedere anche il criterio di esclusione 2.
    8. È un soggetto di sesso maschile o femminile di età pari o superiore a 12 anni (=40 kg per adolescenti [età 12-17 anni]) al momento della firma del consenso informato.

    Per ulteriori criteri di inclusione si prega di far riferimento al protocollo.
    E.4Principal exclusion criteria
    1. Is unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan.
    2. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years with the following exceptions:
    a) Participants with history of VHL disease will be permitted provided concurrent lesions (other than PPGL for Cohort A1 and pNET for Cohort A2) are localized without immediate need for intervention.
    b) Prior history of surgical resection(s) for concurrent localized VHL disease-associated tumors is allowed provided there is no history of metastatic disease from concurrent tumors; history of systemic therapy for concurrent tumors will be exclusionary.
    c) Participants with history of other genetic syndromes will be allowed provided concurrent tumors (outside of the organ affected in Cohort A1 and Cohort A2, respectively) are localized and do not require immediate
    intervention; history of metastatic disease in concurrent tumors or history of systemic therapy for concurrent tumors will be exclusionary.
    3. Has known CNS metastases and/or carcinomatous meningitis.
    4. Has any of the following:
    • Hypoxia as defined by a pulse oximeter reading <92% at rest, or
    • Requires intermittent supplemental oxygen, or
    • Requires chronic supplemental oxygen
    5. Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or PTCA =6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Concurrent uncontrolled hypertension defined as blood pressure >150/90 mm Hg despite optimal antihypertensive medications within 2 weeks prior to the first dose of study treatment.
    6. Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
    7. Has had major surgery =4 weeks prior to first dose of study intervention.
    8. Has received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, or other investigational therapy within the past 4 weeks of study entry, or prior biologics or immunotherapy within the past 6 weeks of study entry.
    9. Has received prior locoregional therapies or radiation within the past 4 weeks of study entry.
    10. Has received prior treatment with PRRT/radionuclide therapy or other radiopharmaceutical therapy within the past 12 weeks from screening for participants with pNET.
    11. Has received meta-iodobenzylguanidine (MIBG) therapy or other radiopharmaceutical therapy within the past 12 weeks from screening for participants with PPGL.
    12. Has received prior treatment with any HIF-2a inhibitor (including belzutifan).
    13. Has a known hypersensitivity to the study treatment and/or any of its excipients.
    14. Has toxicities from prior locoregional or systemic or any other therapies that is not recovered to baseline or CTCAE =Grade 1 (with the exception of alopecia).

    For further exclusion criteria please refer to the protocol.
    1. Non è in grado di deglutire farmaci somministrati per via orale o ha un disturbo che potrebbe influenzare l’assorbimento di belzutifan.
    2. Ha un’anamnesi di neoplasia maligna secondaria, a meno che abbia completato un trattamento potenzialmente curativo senza evidenze di neoplasia maligna per 2 anni con le seguenti eccezioni:
    a) I partecipanti con anamnesi di malattia VHL (mutazione VHL germinale documentata da referto del test locale o con diagnosi clinica) saranno ammessi a condizione che le lesioni concomitanti (diverse da PPGL per la coorte A1 e pNET per la coorte A2) siano localizzate senza necessità immediata di intervento.
    b) Un’anamnesi di resezione chirurgica per tumori concomitanti localizzati associati alla malattia di VHL è consentita solo in assenza di un’anamnesi di malattia metastatica da tumori concomitanti; l’anamnesi di terapia sistemica per tumori concomitanti rappresenta un criterio di esclusione.
    c) I partecipanti con anamnesi di altre sindromi genetiche (come quelli con mutazione germinale SDHx o neoplasia endocrina multipla/MEN) saranno ammessi a condizione che i tumori concomitanti (al di fuori dell’organo colpito nella coorte A1 e coorte A2, rispettivamente) siano localizzati e non richiedano un intervento
    immediato; l’anamnesi di malattia metastatica nei tumori concomitanti o anamnesi di terapia sistemica per i tumori concomitanti rappresenta un criterio di esclusione.
    4. Presenta una delle seguenti caratteristiche:
    • Ipossia, stabilita in presenza di una lettura del pulsossimetro <92% a riposo, o
    • Richiede ossigeno supplementare intermittente, o
    • Richiede ossigeno supplementare cronico.
    5. È affetto da patologia cardiaca clinicamente significativa, inclusa angina instabile, infarto acuto del miocardio o bypass coronarico (CABG) o PTCA nei 6 mesi precedenti il Giorno 1 della somministrazione del farmaco sperimentale, oppure insufficienza cardiaca congestizia di classe III o IV secondo la classificazione della New York Heart Association. Ipertensione concomitante non controllata definita come pressione arteriosa >150/90 mm Hg nonostante farmaci antipertensivi ottimali nelle 2 settimane precedenti la prima dose del trattamento sperimentale.
    6. È affetto da disturbi noti di natura psichiatrica o correlati all’abuso di sostanze che potrebbero interferire con il rispetto dei requisiti dello studio.
    7. Ha ricevuto un intervento chirurgico importante =4 settimane precedenti la prima dose del trattamento sperimentale. Nota: l’adeguata guarigione della ferita dopo un intervento chirurgico importante deve essere valutata clinicamente, indipendentemente dal tempo trascorso per l’eleggibilità.
    8. Ha ricevuto un trattamento precedente (eccetto gli analoghi della somatostatina) con chemioterapia, terapia mirata o altra terapia sperimentale nelle ultime 4 settimane prima dell’ingresso nello studio, o biofarmaci o immunoterapia nelle ultime 6 settimane prima dell’ingresso nello studio.
    9. Ha ricevuto precedenti terapie locoregionali o radiazioni nelle ultime 4 settimane prima dell’ingresso nello studio.
    10. Ha ricevuto un precedente trattamento con PRRT/terapia con radionuclidi (come 177Lu-Dotatate) o altra terapia radiofarmaceutica nelle ultime 12 settimane dallo screening per i partecipanti con pNET.
    11. Ha ricevuto una terapia con meta-iodobenzilguanidina (MIBG) o altra terapia radiofarmaceutica nelle ultime 12 settimane dallo screening per i partecipanti con PPGL.
    12. Ha ricevuto un trattamento precedente con qualsiasi inibitore di HIF-2a (incluso belzutifan).
    13. Presenta ipersensibilità nota al trattamento sperimentale o a uno qualsiasi degli eccipienti.
    14. Ha tossicità da precedenti terapie locoregionali o sistemiche o qualsiasi altra terapia che non sono ritornate al basale o CTCAE =grado 1 (con l’eccezione di alopecia).

    Per ulteriori criteri di esclusione si prega di far riferimento al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response (OR): a confirmed complete response (CR) or partial response (PR).
    Risposta obiettiva (OR): una risposta completa (CR) o parziale (PR) confermata.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to approximately 4 years.
    Fino a circa 4 anni.
    E.5.2Secondary end point(s)
    1. Duration of response: the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
    2. Time to response, defined as the time from first dose of belzutifan/MK-6482 to first documented evidence of CR or PR.
    3. Disease control: a confirmed CR, PR, or stable disease (SD).
    4. Progression-free survival: the time from first dose of belzutifan/MK-6482 to the first documented progressive disease (PD) or death from any cause, whichever occurs first.
    5. Overall survival: the time from first dose of belzutifan/MK-6482 until death from any cause.
    6. Number of Participants Who Experienced One or More Adverse Events (AEs).
    7. Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE).
    1. DOR: tempo dalla prima evidenza documentata di CR o PR fino alla progressione di malattia o alla morte per qualsiasi causa, in base all’evento che si verifica per primo.
    2. TTR, definito come il tempo dalla prima dose di belzutifan/MK-6482 alla prima evidenza documentata di CR o PR.
    3. Controllo della malattia: CR, PR o SD confermate.
    4. PFS: tempo dalla prima dose di belzutifan/MK-6482 alla prima PD documentata o alla morte per qualsiasi causa, in base all’evento che si verifica per primo.
    5. OS: tempo dalla prima dose di belzutifan/MK-6482 al decesso per qualsiasi causa.
    6. Eventi avversi (EA).
    7. Interruzioni dovute ad EA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 4 years.
    2. Up to approximately 4 years.
    3. Up to approximately 4 years.
    4. Up to approximately 4 years.
    5. Up to approximately 4 years.
    6. Up to approximately 4 years.
    7. Up to approximately 4 years.
    1. Fino a circa 4 anni.
    2. Fino a circa 4 anni.
    3. Fino a circa 4 anni.
    4. Fino a circa 4 anni.
    5. Fino a circa 4 anni.
    6. Fino a circa 4 anni.
    7. Fino a circa 4 anni.
    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 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 Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.2Open Yes
    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 Yes
    E.8.2.3.1Comparator description
    -
    -
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Canada
    Russian Federation
    Turkey
    United States
    Denmark
    France
    Germany
    Hungary
    Italy
    Spain
    Sweden
    United Kingdom
    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 years4
    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 years4
    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 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: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 68
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 140
    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 Decision2021-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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