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    Summary
    EudraCT Number:2020-003170-44
    Sponsor's Protocol Code Number:VX19-445-117
    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:2021-06-15
    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 number2020-003170-44
    A.3Full title of the trial
    A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis
    Subjects with Abnormal Glucose Metabolism
    Studio di fase 3b, in aperto, per valutare l’effetto di elexacaftor/tezacaftor/ivacaftor sulla tolleranza al glucosio in soggetti affetti da fibrosi cistica con
    metabolismo del glucosio anomalo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis
    Studio per valutare l’effetto di ELX/TEZ/IVA sulla tolleranza al glucosio in soggetti affetti da fib
    A.4.1Sponsor's protocol code numberVX19-445-117
    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 SponsorVERTEX PHARMACEUTICALS INCORPORATED
    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 supportVertex Pharmaceuticals Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVertex Pharmaceuticals Incorporated
    B.5.2Functional name of contact pointClinical Trials and Medical Info
    B.5.3 Address:
    B.5.3.1Street Address50 Northern Avenue
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeMA 02210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18776348789
    B.5.5Fax number+15105958183
    B.5.6E-mailmedicalinfo@vrtx.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2116
    D.3 Description of the IMP
    D.3.1Product nameELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNElexacaftor
    D.3.9.2Current sponsor codeVX-445
    D.3.9.4EV Substance CodeSUB193216
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTezacaftor
    D.3.9.2Current sponsor codeVX-661
    D.3.9.4EV Substance CodeSUB188271
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIVACAFTOR
    D.3.9.1CAS number 873054-44-5
    D.3.9.2Current sponsor codeVX-770
    D.3.9.4EV Substance CodeSUB33103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.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 Ivacaftor
    D.2.1.1.2Name of the Marketing Authorisation holderVertex Pharmaceuticals (Ireland) Ltd.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/556
    D.3 Description of the IMP
    D.3.1Product name150mg IVACAFTOR
    D.3.2Product code [VX-770]
    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 INNIVACAFTOR
    D.3.9.1CAS number 873054-44-5
    D.3.9.2Current sponsor codeVX-770
    D.3.9.4EV Substance CodeSUB33103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    Cystic Fibrosis
    Fibrosi Cistica
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis
    Fibrosi Cistica
    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 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor
    (IVA) on glucose tolerance in CF subjects with impaired glucose
    tolerance (IGT) or CF-related diabetes (CFRD)
    Valutare l’effetto di elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) sulla
    tolleranza al glucosio in soggetti affetti da FC con alterata tolleranza al glucosio
    (IGT) o diabete correlato a FC (CFRD)
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of ELX/TEZ/IVA
    Valutare la sicurezza e la tollerabilità di ELX/TEZ/IVA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF), and,
    when appropriate, an assent form.
    2. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other
    study procedures.
    3. Subjects (male and female) 12 years of age or older on the date of informed consent.
    4. Subjects heterozygous for F508del and an MF mutation (F/MF genotypes).
    a. Genotype should be confirmed at the Screening Visit.
    b. If the screening CFTR genotype result is not received before the first dose of study drug, a previous CFTR genotype laboratory report may be
    used to establish eligibility.
    c. Subjects who have been enrolled and whose screening genotype does not confirm study eligibility must be discontinued from the study
    (Section 9.9).
    5. Forced expiratory volume in 1 second (FEV1) value >o= 30% of predicted mean for age, sex, and height (equations of the Global Lung Function
    Initiative [GLI])9 at the Screening Visit (spirometry measurements must meet American Thoracic Society/European Respiratory Society criteria
    for acceptability and repeatability) and stable CF disease as judged by the investigator.
    6. Willing to remain on a stable CF treatment regimen (other than CFTR modulators) through completion of study participation.
    7. Abnormal glucose tolerance as determined by an OGTT, classified as either IGT (defined as 2-hour post-OGTT blood glucose level 140 to 199
    mg/dL) or CFRD (defined as either fasting hyperglycemia [blood glucose level >126 mg/dL after an 8-hour fast] or 2-hour post-OGTT blood
    glucose level >200 mg/dL).
    1. Il soggetto (o il suo rappresentante legalmente nominato e
    autorizzato) firmerà e daterà un modulo di consenso informato (ICF), e
    quando opportuno, un modulo di assenso.
    2. Disponibilità e capacità di rispettare le visite programmate, il piano di trattamento
    le restrizioni dello studio, gli esami di laboratorio, le linee guida contraccettive e altre
    procedure dello studio.
    3. Soggetti (di sesso maschile e femminile) di età pari o superiore a 12 anni alla data del
    consenso informato.
    4. Soggetti eterozigoti per F508del e una mutazione a funzione minima (MF; genotipi
    F/MF).
    a. Il genotipo deve essere confermato alla Visita di screening.
    b. Se il risultato del genotipo del regolatore della conduttanza transmembrana della fibrosi cistica (CFTR) allo screening non viene ricevuto prima della prima
    dose del farmaco dello studio, un precedente referto di laboratorio del genotipo del CFTR può essere
    utilizzato per stabilire l’idoneità.
    c. I soggetti che sono stati arruolati e il cui genotipo allo screening
    non conferma l’idoneità allo studio devono essere rimossi dallo studio
    (Sezione 9.9).
    5. Volume espiratorio forzato in 1 secondo (FEV1) > o =30% della media
    predetta per età, sesso e altezza (equazioni della Global Lung Function
    Initiative [GLI])9 alla Visita di screening (le misurazioni spirometriche devono
    soddisfare i criteri dell’American Thoracic Society/European Respiratory Society
    per l’accettabilità e la ripetibilità) e la malattia della FC stabile in base al giudizio
    dello sperimentatore.
    6. Disponibilità a continuare ad assumere un regime di trattamento stabile per la FC (diverso dai modulatori del
    CFTR) fino al completamento della partecipazione allo studio.
    7. Tolleranza anomala al glucosio determinata da un test orale di tolleranza al glucosio (OGTT), classificata come
    tolleranza al glucosio compromessa (IGT; definita come livello di glicemia a 2 ore post-OGTT da 140 a 199
    mg/dl) o diabete correlato alla fibrosi cistica (CFRD; definito come iperglicemia a digiuno
    [livello di glicemia >126 mg/dl dopo un digiuno di 8 ore] o livello di glicemia a 2 ore
    post-OGTT >200 mg/dl).
    E.4Principal exclusion criteria
    1. History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an
    additional risk in administering study drug(s) to the subject. This includes, but is not limited to, the following:
    - Clinically significant liver cirrhosis with or without portal hypertension
    - Solid organ or hematological transplantation
    - Alcohol or drug abuse in the past year, including, but not limited to, cannabis, cocaine, and opiates, as deemed by the investigator
    - Cancer, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ (all 3 with no recurrence for the
    last 5 years)
    2. Type 1 or Type 2 diabetes, or a first degree relative with Type 2 diabetes.
    3. Duration of CFRD > o = 5 years.
    4. Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue
    risk for the subject (as deemed by the investigator).
    5. Any of the following abnormal laboratory values at screening:
    - Hemoglobin <10 g/dL
    - Total bilirubin >o= 2 x upper limit of normal (ULN)
    - Aspartate transaminase (AST), alanine transaminase (ALT), gammaglutamyl transferase (GGT), or alkaline phosphatase (ALP) >0=3 xULN
    - Abnormal renal function defined as glomerular filtration rate <o= 45.mL/min/1.73.m2 (calculated by the Counahan-Barratt equation)11
    6. An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug).
    7. Lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, Burkholderia
    cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus). For subjects who have had a history of a positive culture, the investigator
    will apply the following criteria to establish whether the subject is free of infection with such organisms:
    - The subject has not had a respiratory tract culture positive for these organisms within the 12 months before the date of informed consent.
    - The subject has had at least 2 respiratory tract cultures negative for such organisms within the 12 months before the date of informed
    consent, with the first and last of these separated by at least 3 months, and the most recent one within the 6 months before the date of informed
    consent.
    8. An acute illness not related to CF (e.g., gastroenteritis) within 14 days before the first dose of study drug (Day 1).
    9. Ongoing or prior participation in an investigational drug study (including studies investigating ELX with or without coadministration of
    other study drugs) within 28 days of the Screening Visit.
    - A washout period of 5 terminal half-lives of the previous investigational
    study drug, or 28 days, whichever is longer, must elapse before the Screening Visit.
    - The duration of the elapsed time may be longer if required by local
    regulations.
    10. Use of restricted medication (including antidiabetic medication other
    than insulin, which must be at a dose no greater than 0.3 units/kg/day)
    within specified duration before the first dose of study drug as defined in
    Table 9-1.
    11. BMI >o=30 kg/m2 at the Screening Visit.
    12. Pregnant and breast-feeding females. All female subjects regardless
    of childbearing potential status (Section 11.4.6) must have a negative
    pregnancy test at the Screening Visit and the Day 1 Visit.
    13. The subject or a close relative of the subject is the investigator or a
    subinvestigator, research assistant, pharmacist, study coordinator, or
    other staff directly involved with the conduct of the study at that site.
    However, an adult (aged 18 years or older) who is a relative of a study
    staff member may be enrolled in the study provided that
    - the adult lives independently of and does not reside with the study staff member, and
    - the adult participates in the study at a site other than the site at which the family member is employed.
    1. Anamnesi di qualsiasi malattia o condizione clinica che, secondo il giudizio dello sperimentatore, potrebbe confondere i risultati dello studio o creare
    un ulteriore rischio nella somministrazione del/i farmaco/i dello studio al soggetto. Queste includono, a titolo esemplificativo ma non esaustivo, quanto segue:
    - cirrosi epatica clinicamente significativa con o senza ipertensione portale
    - Trapianto di organo solido o ematologico
    - Abuso di alcol o di sostanze stupefacenti nell’ultimo anno, inclusi, a titolo esemplificativo ma non esaustivo,
    cannabis, cocaina e oppiacei, in base al parere dello sperimentatore
    - Tumore, ad eccezione del carcinoma cutaneo a cellule squamose, del carcinoma cutaneo basocellulare,
    e del carcinoma cervicale di stadio 0 in situ (tutti i 3 senza recidiva per gli ultimi 5 anni)
    2. Diabete di tipo 1 o di tipo 2 o un parente di primo grado con diabete di tipo 2.
    3. Durata del CFRD > o = 5 anni.
    4. Qualsiasi anomalia di laboratorio clinicamente significativa allo screening
    Visita che interferirebbe con le valutazioni dello studio o che porterebbe un rischio ingiustificato per il soggetto (in base al parere dello sperimentatore).
    5. Uno qualsiasi dei seguenti valori di laboratorio anomali allo screening:
    - emoglobina < 10 g/dl
    - Bilirubina totale >o= 2 x limite superiore della norma (ULN)
    - Aspartato aminotransferasi (AST), alanina aminotransferasi (ALT) e gamma-glutamiltransferasi (GGT) o fosfatasi alcalina (ALP) >o=3 x ULN
    - Funzione renale anomala definita come velocità di filtrazione glomerulare
    < o = 45 ml/min/1,73m2 (calcolata in base all’equazione di Counahan-Barratt)11
    6. Infezione acuta delle vie aeree superiori o inferiori, riacutizzazione polmonare o cambiamenti nella terapia (compresi gli antibiotici) per
    la malattia polmonare nei 28 giorni precedenti il Giorno 1 (prima dose del farmaco dello studio).
    7. Infezione polmonare con organismi associati a un declino più rapido dello stato polmonare (inclusi, a titolo esemplificativo ma non esaustivo, Burkholderia cenocepacia, Burkholderia dolosa e Mycobacterium abscessus). Per i soggetti che avevano avuto un’anamnesi di coltura positiva, lo sperimentatore applicherà i seguenti criteri per stabilire se il soggetto è privo di infezione da tali organismi:
    - il soggetto non aveva presentato una coltura del tratto respiratorio positiva per questi
    organismi entro i 12 mesi precedenti la data del consenso informato.
    - Il soggetto aveva presentato almeno 2 colture del tratto respiratorio negative per tali organismi entro i 12 mesi precedenti la data del consenso
    informato, con la prima e l’ultima di queste a distanza di almeno 3 mesi, e quella più recente nei 6 mesi precedenti la data del consenso informato
    8. Una malattia acuta non correlata alla FC (per es. gastroenterite) entro 14 giorni prima della prima dose del farmaco dello studio (Giorno 1).
    9. Partecipazione in corso o precedente a uno studio su un farmaco sperimentale (inclusi studi volti a valutare ELX con o senza somministrazione concomitante di altri farmaci dello studio) entro 28 giorni dalla Visita di screening.
    - Deve essere trascorso un periodo di washout di 5 emivite terminali del precedente farmaco sperimentale dello studio, oppure un periodo di 28 giorni, a seconda di quale sia il periodo più lungo, prima della Visita di screening.
    10. Uso di farmaci soggetti a restrizioni (inclusi farmaci antidiabetici oltre all’insulina, la cui dose non deve essere superiore a 0,3 unità/kg/die)
    entro la durata specificata prima della prima dose di farmaco dello studio, come definito nella Tabella 9-1.
    11. IMC > o =30 kg/m2 alla Visita di screening.
    12. Donne in gravidanza e allattamento. Tutti i soggetti di sesso femminile, indipendentemente dallo stato di età fertile (Sezione 11.4.6) devono risultare negativi al test di gravidanza alla Visita di screening e alla Visita del Giorno 1.
    13. vedere inglese
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in 2-hour blood glucose levels following an oral glucose tolerance test
    (OGTT) to the average of Week 36 and Week 48
    Variazione dei livelli di glicemia a 2 ore dopo un test orale della tolleranza al
    glucosio (OGTT) dal basale alla media della Settimana 36 e della Settimana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 36 and Week 48
    settimana 36 e settimana 48
    E.5.2Secondary end point(s)
    -Proportion of subjects with improvement in dysglycemia categorization (CFRD, IGT, normal glucose tolerance [NGT]) at Week 48
    -Safety and tolerability of ELX/TEZ/IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry
    -Percentuale di soggetti con migliorata categorizzazione di disglicemia (CFRD, IGT, normale tolleranza al glucosio [NGT]) alla Settimana 48
    -Sicurezza e tollerabilità di ELX/TEZ/IVA basate su eventi avversi (EA), valori clinici di laboratorio, ECG, segni vitali e pulsossimetria
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48
    settimana 48
    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 No
    E.6.7Pharmacodynamic Yes
    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
    Tolerance
    tolleranza
    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 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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Belgium
    Czechia
    France
    Italy
    Netherlands
    Spain
    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
    Last scheduled visit (or scheduled contact) of the last subject
    Ultima visita programmata (o ultimo contatto programmato) dell'ultimo soggetto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 20
    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: 20
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    subjects under age incapable of giving consent personally
    soggetti minorenni incapaci di dare personalmente il proprio consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 60
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ECFS Clinical Trials Network
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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