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    Summary
    EudraCT Number:2018-003481-13
    Sponsor's Protocol Code Number:NEAT44
    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:2020-11-06
    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 number2018-003481-13
    A.3Full title of the trial
    An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease. The Late Presenter Treatment Optimisation Study (LAPTOP).
    Studio in aperto, multicentrico, randomizzato, volto a esaminare una terapia antiretrovirale con inibitore dell’integrasi rispetto a un inibitore della proteasi potenziato per i pazienti affetti da malattia da HIV in stadio avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Investigate two therapy against HIV virus for Patients with Advanced Disease.
    Stuido clinico volto a esaminare due terapie per la malattia da HIV per i pazienti affetti da malattia in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    LAPTOP - Late Presenter Treatment Optimisation Study
    LAPTOP
    A.4.1Sponsor's protocol code numberNEAT44
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03696160
    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 SponsorNEAT ID Foundation
    B.1.3.4CountryBelgium
    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 supportGilead Sciences, Inc.,
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJanssen Pharmaceutica NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch Organisation (KC) Ltd
    B.5.2Functional name of contact pointLAPTOP Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressThe Stanley Building, 7 Pancras Square
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeN1C 4AG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+447508533444
    B.5.6E-maillaptop@rokcservices.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 Yes
    D.2.1.1.1Trade name Biktarvy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameBiktarvy
    D.3.2Product code [J05AR]
    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 INNBictegravir
    D.3.9.1CAS number 1611493-60-7
    D.3.9.2Current sponsor codeN/A
    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 INNEMTRICITABINA
    D.3.9.1CAS number 143491-54-7
    D.3.9.2Current sponsor codeN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR ALAFENAMIDE
    D.3.9.1CAS number 383365-04-6
    D.3.9.2Current sponsor codeN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 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 Symtuza
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSymtuza
    D.3.2Product code [J05AR22]
    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 INNDarunavir ethanolate
    D.3.9.1CAS number 635728-49-3
    D.3.9.2Current sponsor codeN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcobicistat
    D.3.9.1CAS number 1004316-88-4
    D.3.9.2Current sponsor codeN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINA
    D.3.9.1CAS number 143491-54-7
    D.3.9.2Current sponsor codeN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTenofovir alafenamide fumarate
    D.3.9.1CAS number 1392275-56-7
    D.3.9.2Current sponsor codeN/A
    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) 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
    Patients who present late on during their acquisition of the HIV-1 (Human Immunodeficiency Virus)
    Pazienti che si presentano ie l'acquisizione tardiva dell'HIV-1 (virus dell'immunodeficienza umana)
    E.1.1.1Medical condition in easily understood language
    HIV infection - A virus that damages the patient's immune system causing difficulties in fighting other infections and diseases.
    Infezione da HIV-Un virus che danneggia il sistema immunitario del paziente causando difficoltà nel combattere altre infezioni e malattie.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of an INI containing regimen [bictegravir (B)/emtricitabine (F)/tenofovir alafenamide (TAF) QD] versus a boosted PI regimen [darunavir (D)/cobicistat (C)/emtricitabine (F)/tenofovir alafenamide (TAF) QD] in patients with advanced HIV infection.
    Dimostrare la non inferiorità di un regime contenente INI [bictegravir (B)/emtricitabina (F)/tenofovir alafenamide (TAF) una volta al giorno (QD)] rispetto a un regime di PI potenziato [darunavir (D)/cobicistat (C)/emtricitabina (F)/tenofovir alafenamide (TAF) QD] in pazienti con infezione da HIV in stadio avanzato.
    E.2.2Secondary objectives of the trial
    To investigate the immunological and virological response, tolerability, resistance development, discontinuation of therapy due to tolerability, QOL and IRIS incidence.
    Studiare la risposta virologica e immunologica, la tollerabilità, lo sviluppo di resistenza, l’interruzione della terapia a causa della tollerabilità, la qualità della vita (QOL) e l’incidenza della sindrome infiammatoria da immunoricostituzione (IRIS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand and sign a written informed consent form (ICF) and must
    be willing to comply with all study requirements
    2. = 18 years
    3. HIV-1 infected AIDS except active tuberculosis (TB) or cryptococcal meningitis with any CD4 cell count, or; severe bacterial infection (BI) and must have a CD4 cell count < 200/µL within 28 days prior to study entry, or; any symptoms or no symptoms with CD4 cell count < 100/µL within 28 days prior to study entry and must have an entry HIV viral load > 1000 copies/mL, or; currently being treated for opportunistic infections (OI)
    4. Have an entry HIV viral load > 1000 copies/mL
    5. Able to take oral medications
    6. ART-naïve prior to study enrolment
    7. Willing to use acceptable methods of contraception
    1. Capacità di comprendere e firmare un modulo di consenso informato (ICF) scritto e disponibilità ad attenersi a tutti i requisiti dello studio
    2. Età =18 anni
    3. AIDS con infezione da HIV-1, ad eccezione di tubercolosi attiva (TBC) o meningite criptococcica con qualsiasi conta delle cellule CD4, oppure grave infezione batterica (IB) e con una conta delle cellule CD4 <200/µl nei 28 giorni precedenti all’ingresso nello studio, oppure soggetti asintomatici con conta delle cellule CD4 <100/µl nei 28 giorni precedenti all’ingresso nello studio e con una carica virale dell’HIV all’ingresso >1000 copie/ml, oppure attualmente in trattamento per infezioni opportunistiche (IO)
    4. Carica virale dell’HIV all’ingresso >1000 copie/ml
    5. In grado di assumere farmaci per via orale
    6.Naïve all’ART prima dell’arruolamento nello studio
    7. Disposti a utilizzare metodi contraccettivi accettabili
    E.4Principal exclusion criteria
    1. Any therapeutic ARV which commenced less than 2 weeks prior to screening and which was taken for more than 48 hours

    2. Systemic cancer chemotherapy within 30 days prior to study entry, or current treatment for cancer (with the exception of Kaposi’s sarcoma) or lymphoma.

    3. Current or anticipated use of contraindicated medications or anticipated systemic chemotherapy during study enrolment (administration of any contraindicated medication must be discontinued at least 30 days prior to the baseline visit and for the duration of the study).

    4. Known resistance to the components of study medications (see section 6.1.3 for more details).

    5. History or symptoms of advanced renal and/or hepatic impairment. Such as, kidney failure requiring dialysis; eGFR <30 mL/min; hepatic transaminases (AST and ALT) > 5 x upper limit of normal (ULN); or, platelet count <50,000.

    6. Current drug or alcohol use that, in the opinion of the Investigator, would cause interference with the study.

    7. Cryptococcal meningitis or active TB or current or expected treatment requiring Rifampicin or Rifabutin (patients with expected latent TB will have a TB test (IGRAs e.g. ELISPOT, QuantiFERON etc.) at their screening visit).

    8. History or presence of allergy to the study drugs or their components, or drugs of their class.

    9. Using any concomitant therapy disallowed as per the reference safety information (RSI) and product labelling for the study drugs.

    10. Any investigational drug within 30 days prior to the study drug administration.

    11. Patients with severe (Child Pugh class C) hepatic impairment.

    12. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study.

    13. Females of childbearing potential and heterosexually active males must be willing to use a highly effective method of contraception.
    1. Qualsiasi terapia ARV iniziata meno di due settimane prima dello screning ed assunta per piu di 48 ore.

    2. Chemioterapia stemica nei precedenti 30 giorni prima dell'inizio dello studio o trattamento in corso per tumori (ad eccezione del sarcoma di Kaposi) o linfoma.

    3. Uso corrente o previsto di farmaci controindicati o chemioterapia sistemica anticipata durante l'iscrizione allo studio (la somministrazione di qualsiasi farmaco controindicato deve essere interrotta per almeno 30 giorni prima della visita di base e per la durata dello studio).

    4. Resistenza nota ai componenti dei farmaci in studio

    5. Storia o sintomi di insufficienza renale e / o epatica avanzata. Come l'insufficienza renale che necesita di dialisi; eGFR <30 mL / min; transaminasi epatiche (AST e ALT)> 5 x limite superiore della norma (ULN); oppure, conta piastrinica <50.000.

    6. Uso corrente di droghe o alcol che, secondo l'opinione dell'Investigatore, potrebbero causare interferenze con lo studio.

    7. Meningite criptococcica o tubercolosi attiva o trattamento attuale o atteso che richiede rifampicina o rifabutina (i pazienti con tubercolosi latente attesa dovranno sottoporsi a un test della tubercolosi (IGRA ad es. ELISPOT, QuantiFERON ecc.) Alla visita di screening).

    8. Storia o presenza di allergia ai farmaci in studio o ai loro componenti o ai farmaci della loro classe.

    9. L'uso di qualsiasi terapia concomitante non è consentito secondo il reference safety information (RSI) e l'etichettatura del prodotto per i farmaci in studio.

    10. Qualsiasi farmaco sperimentale entro 30 giorni prima della somministrazione del farmaco in studio.

    11. Pazienti con insufficienza epatica grave (classe Child Pugh C).

    12. Donne in gravidanza, in allattamento o che stanno pianificando una gravidanza o allattamento durante lo studio.

    13. Le femmine in età fertile e i maschi eterosessualmente attivi devono essere disposti a utilizzare un metodo contraccettivo altamente efficace.
    E.5 End points
    E.5.1Primary end point(s)
    Time to failure, as the first occurrence of any of the following components:

    1. Virological reasons:
    a) Virological failure, defined as insufficient virological response (specifically HIV-1 RNA reduction < 1 log 10 copies/mL at week 12; or viral load > 50 HIV-1 RNA copies/mL at week 48); or viral rebound, defined as rebound > 1 log 10 copies/mL of any post baseline HIV-1 RNA nadir > 400 copies/mL; or defined as rebound in HIV-1 RNA to >200 copies/mL after having achieved HIV-1 RNA <50 copies/mL, which is subsequently confirmed at the following scheduled or unscheduled visit.

    2. Clinical reasons:
    a) Death related to HIV, AIDS, OI/severe BI or complications of therapy including IRIS
    b) Any new or recurrent AIDS defining event
    c) Any new serious non-AIDS defining event documented by the endpoint review committee (including severe BI, liver cirrhosis, renal failure, cardiovascular event, and non-AIDS related malignant disease)
    d) Clinically relevant AEs of any grade which require treatment interruption of INI or boosted PI therapy within the first 48 weeks after randomisation (discontinuation of BIC or boosted DRV followed by continuation with another INI or PI, respectively, is not considered as a strategy failure or endpoint)
    Tempo al fallimento da trattamento, descritto come occorrenza di uno dele seguenti ragioni

    1. Ragioni virologiche:
    a) Insufficienza virologica, definita come risposta virologica insufficiente (in particolare riduzione dell'RNA dell'HIV-1 <1 log 10 copie / mL alla settimana 12; o carica virale> 50 copie dell'RNA dell'HIV-1 / mL alla settimana 48); o rimbalzo virale, definito come rimbalzo> 1 log 10 copie / mL di qualsiasi nadir di HIV-1 RNA post baseline> 400 copie / mL; o definito come rimbalzo dell'RNA dell'HIV-1 a> 200 copie / mL dopo aver raggiunto l'RNA dell'HIV-1 <50 copie / mL, che è successivamente confermato alla successiva visita programmata o non programmata.

    2. Ragioni cliniche:
    a) Morte correlata a HIV, AIDS, OI / BI grave o complicanze della terapia incluso IRIS
    b) Eventuali eventi nuovi o ricorrenti che definiscono l'AIDS
    c) Eventuali nuovi eventi gravi che non definiscono l'AIDS documentati dal comitato di revisione degli endpoint (inclusi BI grave, cirrosi epatica, insufficienza renale, evento cardiovascolare e malattia maligna non correlata all'AIDS)
    d) gli eventi avversi clinicamente rilevanti di qualsiasi grado che richiedono l'interruzione del trattamento di INI o una terapia PI potenziata entro le prime 48 settimane dopo la randomizzazione (l'interruzione di BIC o DRV potenziato seguita da una continuazione con un altro INI o PI, rispettivamente, non è considerata un fallimento della strategia o endpoint)
    E.5.1.1Timepoint(s) of evaluation of this end point
    This end point is a composite end point and is dependent on whether the patients experience virological failure.
    Questo endpoint è un endpoint composito e dipende dal fatto che i pazienti manifestino insufficienza virologica.
    E.5.2Secondary end point(s)
    Proportion of patients with HIV-RNA viral load < 50 copies/mL at week 24, 36, 48

    HIV-1 drug resistance at confirmed virological failure (genotype)

    Time to reach CD4 count > 200/µL (first measurement)

    Proportion of patients with CD4 cell count < 200 µL and < 350µL at week 4, 8, 12, 24, 36, 48

    CD4/CD8 ratio at week 4, 8, 12, 24, 36, 48

    Incidence of IRIS in the two arms through week 48

    Incidence and duration of hospitalisation, rate of relapse of specific OI/BI through week 48

    Safety and tolerability, measured by Grade 2, 3 and 4 signs and symptoms and laboratory toxicities through week 48

    ART and OI/BI treatment changes and dose modifications due to toxicities and DDI with ART, and IRIS through week 48

    Health care resource use, including total inpatient days and emergency room visits through week 48

    QOL and functional status outcomes, including overall self-reported QOL and functional status compared in the two groups at week 48

    Discontinuation or modification of study medication due to insufficient virological response or resistance mutation development before week 48
    Proporzione di pazienti con carica virale HIV-RNA <50 copie / mL alla settimana 24, 36, 48 nei due bracci

    Resistenza ai farmaci per l'HIV-1 a fallimento virologico confermato (genotipo)

    Tempo per raggiungere il conteggio CD4> 200 / µL (prima misurazione)

    Proporzione di pazienti con conta delle cellule CD4 <200 µL e <350µL alla settimana 4, 8, 12, 24, 36, 48

    Rapporto CD4 / CD8 alla settimana 4, 8, 12, 24, 36, 48

    Incidenza dell'IRIS nei due bracci fino alla settimana 48

    Incidenza e durata del ricovero, tasso di recidiva di OI / BI specifici fino alla settimana 48

    Sicurezza e tollerabilità, misurate con segni e sintomi di grado 2, 3 e 4 e tossicità di laboratorio fino alla settimana 48

    Cambiamenti del trattamento ART e OI / BI e modifiche della dose dovute a tossicità e DDI con ART e IRIS fino alla settimana 48

    Utilizzo delle risorse sanitarie, compresi i giorni totali di degenza e le visite al pronto soccorso durante la settimana 48

    QOL e risultati dello stato funzionale, inclusi QOL generale auto-riferito e stato funzionale rispetto ai due gruppi alla settimana 48

    Sospensione o modifica del farmaco in studio a causa dell'insufficiente risposta virologica o dello sviluppo di mutazione della resistenza prima della settimana 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each timepoint is listed above
    I singoli endpoint sono indicati nella sezione E.5.2.IT
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 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 (Ultima Visita, ultimo soggetto)
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 440
    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)
    No post trial medication will be provided to participants. Following their last treatment visit at Week 48 participants will receive treatment as per local standard of care.
    Nessun farmaco, dopo la conlcusione dello studio, sarà fornito ai partecipanti. Dopo l'ultima visita di trattamento alla settimana 48, i partecipanti riceveranno il trattamento secondo lo standard di cura locale.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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