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    Summary
    EudraCT Number:2020-005619-35
    Sponsor's Protocol Code Number:REFINE2020
    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:2021-08-02
    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 number2020-005619-35
    A.3Full title of the trial
    SINGLE-CELL DEEP PHENOTYPING OF B LYMPHOCYTES TO PERSONALIZE IMMUNOTHERAPY IN PATIENTS WITH MYASTHENIA GRAVIS: CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RITXUXIMAB IN GENERALIZED ACHR-ANTIBODY POSITIVE MYASTHENIA GRAVIS
    Fenotipizzazione dei linfociti B con studio della singola cellula per la personalizzazione dell’immunoterapia in pazienti con Miastenia Gravis: studio clinico randomizzato controllato contro placebo per valutare l’efficacia e la sicurezza del Rituximab in pazienti con Miastenia Gravis generalizzata associata ad anticorpi anti-recettore dell’Acetilcolina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SINGLE-CELL DEEP PHENOTYPING OF B LYMPHOCYTES TO PERSONALIZE IMMUNOTHERAPY IN PATIENTS WITH MYASTHENIA GRAVIS: CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF RITXUXIMAB IN GENERALIZED ACHR-ANTIBODY POSITIVE MYASTHENIA GRAVIS
    Fenotipizzazione dei linfociti B con studio della singola cellula per la personalizzazione dell’immunoterapia in pazienti con Miastenia Gravis: studio clinico randomizzato controllato contro placebo per valutare l’efficacia e la sicurezza del Rituximab in pazienti con Miastenia Gravis generalizzata associata ad anticorpi anti-recettore dell’Acetilcolina
    A.3.2Name or abbreviated title of the trial where available
    REFINE 2020
    REFINE 2020
    A.4.1Sponsor's protocol code numberREFINE2020
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Policlinico Universitario A. Gemelli IRCCS
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressLargo A. Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00135
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.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.2.5The 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 namerituximab
    D.3.2Product code [rituximab]
    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 INNrituximab
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor coderituximab
    D.3.9.3Other descriptive namerituximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product 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 placeboInfusion
    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
    Generalized AChR-antibody positive Myasthenia Gravis
    Miastenia Gravis generalizzata associata ad anticorpi anti-recettore dell’Acetilcolina
    E.1.1.1Medical condition in easily understood language
    generalized AChR-antibody positive Myasthenia Gravis
    Miastenia Gravis generalizzata associata ad anticorpi anti-recettore dell’Acetilcolina
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028417
    E.1.2Term Myasthenia gravis
    E.1.2System Organ Class 10029205 - Nervous system 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 assess whether rituximab can reduce MG-related functional impairment.
    L’obiettivo primario dello studio è valutare se il Rituximab è efficace nel produrre un miglioramento clinico nei pazienti miastenici, riducendo le limitazioni funzionali dovute alla malattia.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of rituximab on corticosteroid usage.
    2. To evaluate the effect of rituximab on MG-related disability.
    3. To evaluate whether rituximab can improve MG-related quality of life.
    4. To evaluate the safety and tolerability of rituximab in MG.
    5. To evaluate if rituximab reduces MG exacerbations
    Gli obiettivi secondari sono:
    (1) valutare l’efficacia del Rituximab come farmaco “risparmiatore di corticosteroidi”;
    (2) valutare l’efficacia del Rituximab nel migliorare la limitazione dell’autonomia dei pazienti dovuta alla miastenia;
    (3) valutare l’efficacia del Rituximab nel migliorare la qualità della vita dei pazienti miastenici;
    (4) valutare la sicurezza e la tollerabilità del Rituximab nei pazienti con MG;
    (5) valutare se il Rituximab riduce le riesacerbazioni di malattia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects = 18 years old.
    2. Written informed consent and European Union Data Privacy Directive obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
    3. Diagnosis of MG defined as:
    a. Positive serologic test for anti-AChR or anti-MuSK antibody titers as confirmed at screening (one retest allowed), and
    b. At least one of the following:
    • History of abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; or
    • History of positive anticholinesterase test (eg, edrophonium chloride test); or
    • Patient demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician; or
    • Clinical syndrome consistent with a diagnosis of MG, and not otherwise explained by another condition.
    4. MGFA Clinical Classification Class II, III, or IV at the time of screening and randomization.
    5. MG-ADL score of 5 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.
    6. QMG score of 11 or greater at screening and at randomization.
    7. Subjects must be on corticosteroids only, with no dose increase within 4 weeks prior to randomization and at least 20 mg prednisone per day (or equivalent dose on alternate day regimen)
    8. Willing and able to comply with the protocol, complete study assessments, and return for follow-up visits.
    9. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective contraception method (Table 1) from the time of screening and for 6 months after the final dose of IP. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause).
    10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom from Day 1 for the duration of the study and for 3 months after the last dose of IP. Because male condom is not a highly effective contraception method, it is strongly recommended that female partners of a male study subject also use a highly effective method of contraception throughout this period (Table 1).
    11. Vital signs, electrocardiogram (ECG), and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the Investigator.
    1. Età minima di 18 anni al momento della firma del consenso informato.
    2. Fornire un consenso informato scritto alla partecipazione allo studio e consenso al trattamento dei dati personali
    3. Diagnosi di MG, formulata in base ai seguenti criteri:
    a) test sierologico positivo per gli anticorpi anti-AChR (da ripetere allo screening se eseguito prima di 3 mesi dalla visita di screening) e
    b) almeno uno dei test seguenti:
    - disturbo della trasmissione neuromuscolare dimostrato da un’elettromiografia a singola fibra o stimolazione nervosa ripetuta
    - positività al test con anticolinesterasici (ad es. test all’edrofonio cloruro)
    - chiaro miglioramento clinico (secondo la valutazione del medico curante) in seguito a terapia orale con inibitori della colinesterasi
    - quadro clinico compatibile con una diagnosi di MG e non altrimenti spiegabile da altre condizioni.
    4. Classificazione clinica allo screening in classe da II a IV secondo la Myasthenia Gravis Foundation of America (Fondazione Americana della Miastenia Grave)
    5. Il punteggio MG-ADL deve essere = 5 allo screening e alla randomizzazione (Giorno 1) con più del 50% del punteggio attribuito a item di interessamento non oculare
    6. Punteggio alla scala QMG = 11 allo screening ed alla randomizzazione (Giorno 1)
    7. Assunzione di sola terapia corticosteroidea (con o senza terapia sintomatica con piridostigmina), ad una posologia stabile almeno per le 4 settimane precedenti lo screening, con un dosaggio di prednisone = 20 mg al dì (o dose equivalente con regime a giorni alterni)
    8. Soggetti motivati a partecipare e completare lo studio clinico e a seguire le indicazioni del protocollo
    9. I soggetti di sesso femminile in età fertile dovranno praticare astinenza sessuale o, in alternativa, usare un metodo contraccetivo altamente efficace
    10. I soggetti di sesso maschile non vasectomizzati, sessualmente attivi, il cui partner è un soggetto di sesso femminile in età fertile, dovranno utilizzare il profilattico durante l’attività sessuale dal giorno 1 del trial fino a 3 mesi dall’ultima dose di farmaco ricevuta.
    11. Riscontro di parametri vitali, ECG e valori degli esami di laboratorio nella norma allo screening o, se anormali, giudicati come non clinicamente significativi dallo sperimetatore.
    E.4Principal exclusion criteria
    1. Any condition that, in the opinion of the Investigator, would place the patient at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of patient safety or study results.
    2. Lactating or pregnant females, or females who intend to become pregnant anytime from signing the informed consent form (ICF) throughout the RCP plus 6 months following last dose of IP.
    3. History of drug or alcohol abuse within < 1 year prior to screening, or any condition associated with poor compliance as judged by the Investigator.
    4. Site staff and their family members.
    5. Currently committed to an institution by way of official or judicial order.
    6. Subjects diagnosed with congenital myasthenic syndromes.
    7. Known immunodeficiency disorder, including human immunodeficiency virus (HIV) infection.
    8. Thymectomy within = 12 months prior to baseline (Day 1) visit or planned thymectomy during the duration of the RCP.
    10. Receipt of the following medications or treatments at any time prior to randomization:
    a. Alemtuzumab (Lemtrada®, Campath®)
    b. Total lymphoid irradiation
    c. Bone marrow transplant
    d. T-cell vaccination therapy
    e. Natalizumab (Tysabri®)
    10. Receipt of ANY immunosuppressive treatment (excluding corticosteroids) at ANY time prior to randomization (such as Azathioprine, Mycophenolate mofetil or Mycophenolic acid, Cyclosporine (except eye drop), Tacrolimus (except topical), Methotrexate, Cyclophosphamide, Tocilizumab (Actemra®), Belimumab (Benlysta®), Eculizumab (Soliris®), rituximab (MabThera®, Rituxan®), ocrelizumab (Ocrevus®), ofatumumab (Arzerra®), obinutuzumab (Gazyva®), inebilizumab, or any experimental B-cell depleting agent)
    11. Receipt within the 4 weeks prior to Day 1:
    a. Intravenous immunoglobulin (IVIg)
    b. Plasma exchange (PLEX) treatment
    12. Current use of:
    a. Prednisone < 20 mg/day or < 40 mg over a 2-day period (or equivalent dose of other corticosteroids)
    b. Pyridostigmine > 480 mg/day or unstable dose in the 2 weeks prior to Day 1
    13. Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 half-lives of the investigational treatment, whichever is longer, prior to Day 1.
    14. Receipt of a live attenuated vaccine within 4 weeks prior to randomization. Administration of inactivated (killed) vaccines is acceptable.
    15. History of severe allergic or anaphylactic reactions to biologic agents or known allergy to any component of the IP formulation.
    16. History of recurrent significant infections (eg, requiring hospitalization or IV antibiotics).
    17. Within 2 weeks prior to the screening visit: clinically significant active infection requiring antimicrobial medication but allowing chronic nail infections.
    1. Qualunque condizione che, secondo lo sperimentatore, esporrebbe il soggetto ad un rischio inaccettabile di complicazioni, potrebbe interferire con la valutazione del farmaco in studio, o confondere l’interpretazione dei risultati dello studio e del profilo di sicurezza del farmaco in studio.
    2. Soggetti di sesso femminile in gravidanza o in fase di allattamento, o donne che intendono avere una gravidanza in un periodo compreso tra la firma del consenso informato fino a sei mesi dalla fine del trial clinico.
    3. Anamnesi positiva per abuso di alcol o droghe nell’anno precedente allo screening, o qualunque condizione che, secondo lo sperimentatore, potrebbe determinare una scarsa aderenza de soggetto al protocollo dello studio clinico.
    4. Membri dello staff del sito di sperimentazione e loro familiari.
    5. Soggetti con diagnosi di sindrome miastenica congenita.
    6. Immunodeficienza nota, inclusa infezione da virus dell’immunodeficienza umana (HIV).
    7. Timectomia nei 12 mesi prima del giorno 1 dello studio clinico o intervento di timectomia previsto nel periodo dello studio clinico.
    8. Soggetti che hanno ricevuto i seguenti trattamenti/farmaci in un qualunque momento prima della randomizzazione:
    a. Alemtuzumab
    b. irradiazione linfoide totale
    c. trapianto di midollo osseo
    d. terapia vaccinale con cellule T (CAR-T)
    e. Natalizumab
    9. Aver effettuato qualunque terapia immunosoppressiva (ad eccezione della terapia steroidea) in un qualunque momento prima della randomizzazione (ad es.: azatioprina, micofenolato mofetile o acido micofenolico, ciclosporina (ad eccezione del collirio), Tacrolimus (ad eccezione di trattamenti topici), Metotrexate, ciclofosfamide, Tocilizumab (Actemra®), Belimumab (Benlysta®), Eculizumab (Soliris®), rituximab (MabThera®, Rituxan®), ocrelizumab (Ocrevus®), ofatumumab (Arzerra®), obinutuzumab (Gazyva®), inebilizumab, o qualunuque farmaco sperimentale depletore delle cellule B)
    10. Aver effettuato i seguenti trattamenti nelle 4 settimane prima dello giorno 1 dello studio clinico:
    a. Immunoglobuline umane e.v.
    b. Plasmaferesi
    11. Uso attuale di:
    a. prednisone ad un dosaggio <20 mg/die (o equivalente a giorni alterni)
    b. piridostigimina > 480 mg/die o con una posologia instabile nelle due settimane precedenti il giorno 1
    12. Concomitante partecipazione ad altri trial clinici o precedente partecipazione ad altri studi clinici interventistici nelle 4 settimane precedenti o in un periodo pari a 5 emivite del farmaco in sperimentazione (quale dei due è maggiore) precedentemente al giorno 1 di questo studio clinico.
    13. Aver ricevuto un vaccino vivo attenuato entro 4 settimane prima della randomizzazione (i vaccini inattivati sono accettabili).
    14. Anamnesi positiva per reazioni allergiche severe innescate da agenti biologici o allergia nota al farmaco in studio o ai suoi eccipienti.
    15. Anamnesi positiva per infezioni clinicamente significative ricorrenti (ovvero che hanno richiesto ospedalizzazione o antibiotici somministrati per via parenterale).
    16. Infezione attiva clinicamente rilevante che ha richiesto antibiotici / antimicotici / antivirali nelle 2 settimane prima dello screening (ad eccezione delle infezioni ungueali).
    17. Timoma non trattato (nota: soggetti con timoma begnigno resecato più di 1 anno prima dello screening possono essere inclusi. Per timoma benigno si intende una neoplasia epiteliale timica capsulata, che all’esame istologico non supera né infiltra la capsula, e che non ha determinato metastasi a distanza. Un’indagine radiologica appropriata per escludere la presenza eventuale di timoma deve essere stata effettuata prima della randomizzazione secondo la buona pratica clinica).
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Quantitative Myasthenia Gravis Score (QMG) at week 12 (3 months) of the RCP
    l’endopoint primario sarà valutato alla 12° settimana, prima dell’inizio della fase di riduzione della terapia corticosteroidea. L’endopoint primario sarà valutato analizzando la variazione del punteggio del Quantitative Myasthenia Gravis (QMG) score dal baseline alla 12° settimana del trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 MONTHS
    3 MESI
    E.5.2Secondary end point(s)
    1. Change in corticosteroid dosage from week 12 to the end of the RCP.
    2. Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at week 12.
    3. Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at the end of RCP.
    4. Change from baseline in Quantitative Myasthenia Gravis Score (QMG) score at the end of RCP.
    5. Proportion of subjects with both (1) = 3-point improvement in MG-ADL at end of the RCP (2) no use of rescue therapy during RCP.
    6. Change from baseline in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score at the week 12 and at the end of the RCP
    7. Proportion of patients achieving the status of minimal-manifestation or better at week 12 and the end of the RCP
    8. Proportion of patients requiring rescue therapy during the RCP.
    (1) la variazione della dose media di corticosteroidi dalla settimana 12 (inizio del programma di riduzione del dosaggio secondo criteri pre-stabiliti) rispetto alla fine del trial; (2) la variazione del punteggio alla scala “MG Activities of Daily Living” (MG-ADL) dal baseline alla 12° settimana del trial e dal baseline al termine del trial; (3) variazione del QMG dal baseline al termine del trial; (4) percentuale di pazienti che ottengono un miglioramento di almeno 3 punti alla scala MG-ADL alla fine del trial, senza necessità di ricorrere a terapie di emergenza durante lo studio clinico; (5) variazione del punteggio alla scala “Myasthenia Gravis Quality of Life-15 revised” (MGQOL-15r) dal baseline alla 12° settimana del trial e del baseline al termine del trial; (7) percentuale di pazienti che raggiungo il Post-Intervention Status (PIS) di “manifestazioni minime di malattia” (o migliore) alla fine del trial clinico; (8) percentuale di pazienti che necessitano di ricorrere a terapie di emergenza (a causa di esacerbazioni della malattia) durante il trial clinico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 MONTHS
    12 MESI
    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 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) 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    BEST CLINICAL PRACTICE
    MIGLIORE PRATICA CLINICA
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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