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    Summary
    EudraCT Number:2020-001178-31
    Sponsor's Protocol Code Number:YO42137
    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:2021-05-24
    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 number2020-001178-31
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBODY) IN PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA.
    STUDIO DI FASE III RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, SULL’USO DI ATEZOLIZUMAB CON O SENZA TIRAGOLUMAB (ANTICORPO ANTI-TIGIT) IN PAZIENTI CON CARCINOMA ESOFAGEO A CELLULE SQUAMOSE LOCALMENTE AVANZATO NON RESECABILE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Atezolizumab with or without Tiragolumab (Anti-TIGIT Antibody) in Patients with Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma.
    Uno studio su Atezolizumab con o senza Tiragolumab (anticorpo anti-TIGIT) in pazienti con carcinoma esofageo a cellule squamose localmente avanzato non resecabile
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberYO42137
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nametiragolumab
    D.3.2Product code [RO7092284/F03-01]
    D.3.4Pharmaceutical form Concentrate for 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 INNTIRAGOLUMAB
    D.3.9.1CAS number 1918185-84-8
    D.3.9.2Current sponsor codeRO7092284
    D.3.9.3Other descriptive nameMTIG7192A, anti-TIGIT, aTIGIT, PRO400402, 4.1D3
    D.3.9.4EV Substance CodeSUB197861
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 TECENTRIQ®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH - AIC EU/1/17/1220/001
    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 name-
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Concentrate for 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 INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A, Anti-PDL1, Anti-PD-L1, aPDL1, PRO#303280
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Esophageal squamous cell carcinoma
    Carcinoma esofageo a cellule squamose
    E.1.1.1Medical condition in easily understood language
    Esophageal squamous cell carcinoma occurs most often in the upper and middle portions of the esophagus.
    Il carcinoma eofageo a cellule squamose si verifica più spesso nella parte superiore e nelle porzioni centrali dell'esofago.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10055476
    E.1.2Term Esophageal squamous cell carcinoma
    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 efficacy of tiragolumab + atezolizumab compared with double placebo on the basis of investigator (INV) assessed progression free survival and overall survival
    • To evaluate the efficacy of placebo + atezolizumab compared with double placebo on the basis of overall survival.
    -Valutare l’efficacia di tiragolumab + atezolizumab rispetto al doppio placebo secondo la valutazione della progressione da parte dello sperimentatore basata su sopravvivenza libera da progression e sopravvivenza globale
    -Valutare l’efficacia di placebo + atezolizumab rispetto al doppio placebo sulla base della sopravvivenza globale
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of placebo + atezolizumab compared with double placebo on the basis of INV assessed progression-free survival
    • To evaluate the efficacy of tiragolumab + atezolizumab versus placebo + atezolizumab to demonstrate the contribution of tiragolumab on the basis of INV assessed progression free survival and overall survival
    • To evaluate the efficacy of tiragolumab + atezolizumab and placebo + atezolizumab compared with double placebo and the efficacy of tiragolumab + atezolizumab versus placebo + atezolizumab to demonstrate the contribution of tiragolumab on the basis of independent review facility (IRF) assessed PFS and, IRF-assessed ORR, and INV assessed ORR
    • To evaluate safety and tolerability of tiragolumab + atezolizumab and placebo + atezolizumab compared with double placebo
    • To characterize pharmacokinetics of tiragolumab and atezolizumab
    • To evaluate immune response to tiragolumab and atezolizumab.
    -Valutare l’efficacia di placebo + atezo rispetto al doppio placebo sulla base della PFS progressione valutata dallo sperimentatore
    -Valutare l'efficacia di tira+ atezo rispetto al placebo + atezo per dimostrare il contributo di tiragolumab sulla base della PFS e della sopravvivenza globale valutata dallo sperimentatore
    - Valutare l'efficacia di tiragolumab + atezolizumab e placebo +atezolizumab rispetto al doppio placebo e l'efficacia di tiragolumab + atezolizumab rispetto a placebo + atezolizumab per dimostrare il contributo di tiragolumab sulla base della sopravvivenza libera da progressione e del tasso di risposta obiettiva valutati dall’ Independent Review Facility e del tasso di risposta obiettiva valutato dallo sperimentatore
    - valutare la sicurezza e la tollerabilità di tiragolumab + atezolizumab e placebo + atezolizumab rispetto al doppio placebo
    - Caratterizzare la farmacocinetica di tiragolumab e atezolizumab
    - Valutare la risposta immunitaria a tiragolumab e atezolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age >=18 years
    • Eastern Cooperative Oncology Group Performance Status of 0 or 1
    • Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
    • Stage II-IVA per American Joint Committee on Cancer/Union for International Cancer Control, 8th edition, unresectable locally advanced disease
    • Definitive concurrent chemoradiation treatment according to regional oncology guidelines for esophageal cancer
    • Representative archival formalin-fixed, paraffin-embedded tumor specimens < 3 years old, collected prior to initiation of definitive chemoradiotherapy in paraffin blocks or >= 15 unstained slides containing freshly cut, serial sections
    • Adequate hematologic and end-organ function
    • For women of childbearing potential: agreement to remain abstinent or use contraception 5 months after the final dose of atezolizumab and for 90 days after the final dose of tiragolumab
    • For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, men must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.
    -Età >=18 anni
    -Performance status ECOG pari a 0 o 1
    -Diagnosi istologicamente o citologicamente confermata di carcinoma a cellule squamose dell’esofago
    -Stadio II-IVA secondo l’American Joint Committee on Cancer/Union for International Cancer Control, 8a edizione, malattia localmente avanzata non resecabile
    -Trattamento chemioradioterapico definitivo concomitante in base alle linee guida oncologiche regionali per il cancro dell’esofago
    -Campioni di tumore d’archivio rappresentativi, fissati in formalina e inclusi in paraffina (FFPE), prelevati < 3 anni prima dell’avvio della chemioradioterapia definitiva in blocchi di paraffina o >=15 vetrini non colorati contenenti sezioni seriali appena prelevate
    -Adeguata funzione ematologica e degli organi
    -Per le donne potenzialmente fertili: consenso a praticare l’astinenza sessuale oppure a utilizzare misure contraccettive durante il periodo di trattamento e per 5 mesi dopo l’ultima dose di atezolizumab e per 90 giorni dopo l’ultima dose di tiragolumab.
    -Per i pazienti di sesso maschile: consenso a praticare l’astinenza o a utilizzare il profilattico e consenso ad astenersi dal donare liquido seminale durante il periodo di trattamento e per 90 giorni dopo l’ultima dose di tiragolumab per evitare l’esposizione dell’embrione
    E.4Principal exclusion criteria
    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
    • Any unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE) Grade >= 2 from the prior chemoradiation therapy
    • Evidence of complete esophageal obstruction not amenable to treatment
    • Histology consistent with small cell esophageal carcinoma, esophageal adenocarcinoma, or mixed carcinoma
    • Grade >= 2 peripheral neuropathy as defined by NCI CTCAE v5.0 criteria
    • High risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula, or primary tumor invasion of the great vessels or trachea
    • Prior esophagectomy
    • Active or history of autoimmune disease or immune deficiency
    • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
    • History of malignancy other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
    • Treatment with any other investigational agent, including EGFR inhibitors, with therapeutic intent for esophageal cancer prior to randomization.
    - Precedente trattamento con agonisti del CD137 o con terapie di blocco dei checkpoint immunitari, inclusi anticorpi terapeutici anti-CTLA-4, anti-PD-1, anti-PD-L1 e anti-TIGIT
    -Eventuali tossicità non risolte di grado NCI CTCAE v. 5.0 grado >= 2 derivanti dalla precedente chemioradioterapia
    -Evidenza di ostruzione esofagea completa non riconducibile a trattamento
    -Istologia coerente con carcinoma esofageo a piccole cellule o carcinoma misto
    -Neuropatia periferica di grado >=2 secondo la definizione dei criteri NCI CTCAE v 5.0
    -Rischio elevato di sviluppare fistole esofagee rilevabili mediante valutazione clinica o diagnostica per immagini, come precedente storia o sintomi associati di fistola esofagea, o invasione di grandi vasi o della trachea da parte del tumore primitivo
    -Precedente esofagectomia
    -Malattia autoimmune o deficit immunitario attivi o in anamnesi
    -Anamnesi di fibrosi polmonare idiopatica, polmonite in via di organizzazione, polmonite indotta da farmaci o polmonite idiopatica, oppure evidenza di polmonite attiva all’esame di tomografia computerizzata (TC) toracica di screening.
    -Anamnesi di neoplasie maligne diverse da cancro dell’esofago nei 2 anni precedenti lo screening, con l’eccezione delle neoplasie che presentano un rischio trascurabile di metastasi o decesso
    -Trattamento con qualsiasi altro agente sperimentale, compresi inibitori di EGFR, con intento terapeutico per il cancro dell’esofago prima della randomizzazione
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression-Free Survival as determined by the investigator (for tiragolumab + atezolizumab compared with double placebo)
    2. Overall survival (for tiragolumab + atezolizumab compared with double placebo)
    3. Overall Survival (for placebo + atezolizumab compared with double placebo).
    1. Sopravvivenza libera da progressione secondo la valutazione dello sperimentatore (per tiragolumab + atezolizumab rispetto al doppio placebo)
    2. Sopravvivenza globale (per tiragolumab + atezolizumab rispetto al doppio placebo)
    3. Sopravvivenza globale (per placebo + atezolizumab rispetto al doppio placebo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-3. Approximately 50 months.
    1-3. Circa 50 mesi.
    E.5.2Secondary end point(s)
    1. Progression-Free Survival as determined by the investigator (for placebo + atezolizumab compared with double placebo)
    2. Overall Survival (for tiragolumab + atezolizumab versus placebo + atezolizumab to demonstrate the contribution of tiragolumab)
    3. Progression-Free Survival as determined by the independent review facility (IRF)
    4. Confirmed ORR as determined by the investigator
    5. Confirmed ORR as determined by an IRF
    6. Duration of response as determined by the investigator
    7. Duration of response as determined by the IRF
    8. Proportion of patients with clinically meaningful changes in physical functioning, role functioning, global health status/quality of life, and dysphagia, as measured by the respective scales of the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire and the European Organisation for Research and Treatment of Cancer Quality of Life-Esophageal Cancer, Module 18 Questionnaire
    9. Incidence and severity of adverse events
    10. Serum concentration of tiragolumab and atezolizumab at specified timepoints
    11. Prevalence of anti-drug antibody (ADAs) to tiragolumab at baseline and incidence of ADAs to tiragolumab during the study
    12. Prevalence of ADAs to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study.
    1. Sopravvivenza libera da progressione secondo la valutazione dello sperimentatore (per placebo + atezolizumab rispetto al doppio placebo)
    2. Sopravvivenza globale (per tiragolumab + atezolizumab rispetto al placebo + atezolizumab per dimostrare il contributo di tiragolumab)
    3. Sopravvivenza libera da progressione secondo la valutazione dell’ independent review facility (IRF)
    4. tasso di risposta obiettiva confermato come determinato dallo sperimentatore
    5. tasso di risposta obiettiva confermato come determinato da IRF
    6. Durata della risposta determinata dallo sperimentatore
    7. Durata della risposta determinata da IRF
    8. Percentuale di pazienti con variazioni clinicamente rilevanti di funzionalità fisica, funzionalità di ruolo, GHS/QoL e disfagia, misurati con le rispettive scale dei questionari EORTC QLQ-C30 ed EORTC QLQ-OES18
    9.Incidenza e gravità degli eventi avversi
    10.Concentrazioni sieriche di tiragolumab e atezolizumab in punti temporali specifici
    11.Prevalenza di ADA diretti contro tiragolumab al basale e incidenza di ADA diretti contro tiragolumab durante lo studio
    12. Prevalenza di ADA diretti contro atezolizumab al basale e incidenza di ADA diretti contro atezolizumab durante lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- 7. Approximately 50 months
    8. Day 1 of Cycle 1 and Day 1 of every cycle thereafter until treatment discontinuation, and at the study treatment discontinuation visit and during survival follow-up, every 3 months for 1 year
    9. Approximately 50 months
    10-12. Day 1 of Cycle 1, Day 1 of Cycle 2-4, 8, 12, 16 and at treatment discontinuation, disease progression, or completion visit.
    1-7. Circa 50 mesi
    8. Giorno 1 del ciclo 1 e giorno 1 di ogni ciclo successivo fino all’interruzione del trattamento e alla visita di interruzione del trattamento e durante il follow-up di sopravvivenza, ogni 3 mesi per 1 anno
    9. Circa 50 mesi
    10-12. Giorno 1 del ciclo 1, giorno 1 dei cicli 2-4, 8, 12, 16 e all’interruzione del trattamento, progressione della malattia o visita di completamento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker (exploratory) and Health Status Utility Objective.
    Immunogeneticità, Biomarker esporativi, obbietivo utilità dello stato di salute
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Australia
    Brazil
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    New Zealand
    Russian Federation
    South Africa
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    France
    Germany
    Greece
    Hungary
    Italy
    Poland
    Portugal
    Spain
    Switzerland
    United Kingdom
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    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 months38
    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 months50
    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: 285
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 465
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 317
    F.4.2.2In the whole clinical trial 750
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    'None'.
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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