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    Summary
    EudraCT Number:2018-000286-36
    Sponsor's Protocol Code Number:LEVODESA_04-2017
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-11
    Trial results View 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 number2018-000286-36
    A.3Full title of the trial
    An international, multicenter, randomized, blinded-assessor, parallel-group clinical study comparing eye drops of combined LEvofloxAcin + DExamethasone foR 7 days followed by dexamethasone alone for an additional 7 days vs. tobramycin + dexamethasone for 14 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults – LEADER 7.
    Studio clinico internazionale, multicentrico, randomizzato, con valutatore in cieco, a gruppi paralleli di confronto tra gocce oculari contenenti levofloxacina + desametasone per 7 giorni seguiti da solo desametasone per altri 7 giorni rispetto a tobramicina + desametasone per 14 giorni per la prevenzione e il trattamento dell’infiammazione e la prevenzione delle infezioni associate all’intervento chirurgico per cataratta negli adulti - Studio LEADER 7
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study comparing eye drops of combined LEvofloxAcin + DExamethasone foR 7 days followed by dexamethasone alone for an
    additional 7 days vs. tobramycin + dexamethasone for 14 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults.
    Studio clinico per confrontare gocce oculari contenenti levofloxacina + desametasone per 7 giorni seguiti da solo desametasone per altri 7 giorni rispetto a tobramicina + desametasone per 14 giorni per la prevenzione e il trattamento dell’infiammazione e la prevenzione delle infezioni associate all’intervento chirurgico per cataratta negli adulti.
    A.3.2Name or abbreviated title of the trial where available
    LEADER 7
    LEADER 7
    A.4.1Sponsor's protocol code numberLEVODESA_04-2017
    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 SponsorNTC SRL
    B.1.3.4CountryItaly
    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 supportNTC s.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPIS s.r.l.
    B.5.2Functional name of contact pointDipartimento Medico
    B.5.3 Address:
    B.5.3.1Street AddressPalazzo Aliprandi, Via Matteotti 10
    B.5.3.2Town/ cityDesio (MB)
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number003903626331
    B.5.5Fax number00390362633633
    B.5.6E-mailosservatorio@opis.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 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 nameNA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOFLOXACINA
    D.3.9.1CAS number 100986-85-4
    D.3.9.2Current sponsor codeLEVOFLOXACINA
    D.3.9.4EV Substance CodeSUB08471MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.2Current sponsor codeDESAMETASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Maxidex
    D.2.1.1.2Name of the Marketing Authorisation holderAlcon Laboratories (UK) Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameNA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.2Current sponsor codeDESAMETASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 3
    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 TOBRADEX - 0.3% + 0.1% COLLIRIO, SOSPENSIONEFLACONE CONTAGOCCE 5 ML
    D.2.1.1.2Name of the Marketing Authorisation holderALCON-COUVREUR S.A.
    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 nametobramicina+desametasone
    D.3.2Product code [tobramicina+desametasone]
    D.3.4Pharmaceutical form Eye drops, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOBRAMICINA
    D.3.9.2Current sponsor codeTOBRAMICINA
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.2Current sponsor codeDESAMETASONE
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Prevention and treatment of inflammation and prevention of infection associated with cataract surgery
    Prevenzione e trattamento dell’infiammazione e prevenzione delle infezioni associate all'intervento chirurgico per cataratta
    E.1.1.1Medical condition in easily understood language
    Prevention and treatment of inflammation and prevention of infection associated with cataract surgery
    Prevenzione e trattamento dell’infiammazione e prevenzione delle infezioni associate all'intervento chirurgico per cataratta
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007739
    E.1.2Term Cataract
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficay: To demonstrate the non-inferiority of combined levofloxacin + dexamethasone eye drops for 7 days followed by dexamethasone eye drops alone for an additional 7 days vs. standard treatment tobramycin + dexamethasone eye drops for 14 days in the prevention and treatment of postoperative ocular inflammation and prevention of infection.
    Efficacia: dimostrare la non inferiorità della combinazione di levofloxacina + desametasone in gocce oculari per 7 giorni seguito da solo desametasone in gocce oculari per altri 7 giorni rispetto al trattamento standard con tobramicina + desametasone in gocce oculari per 14 giorni nella prevenzione e nel trattamento dell’infiammazione oculare post-chirurgica e nella prevenzione dell’infezione.
    E.2.2Secondary objectives of the trial
    - Safety and tolerability: To evaluate the safety of combined levofloxacin
    - dexamethasone eye drops; To evaluate the tolerability of combined levofloxacin - dexamethasone eye drops.

    - Compliance: To evaluate compliance with prescribed treatment.
    - Sicurezza e tollerabilità: valutare la sicurezza della combinazione di levofloxacina + desametasone in gocce oculari; valutare la tollerabilità della combinazione di levofloxacina + desametasone in gocce oculari.

    Compliance: valutare l’aderenza al trattamento prescritto.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent must be obtained before any assessment is performed
    2. Male or female, age =40 years
    3. Senile or presenile uncomplicated cataract surgery
    4. Willing to interrupt the use of contact lenses for the entire duration of the study
    5. Able and willing to follow study procedures
    6. Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception, which include an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide.
    1. Consenso informato scritto ottenuto prima dell’effettuazione di qualsiasi valutazione
    2. Pazienti di sesso maschile o femminile, di età =40 anni
    3. Intervento chirurgico non complicato di cataratta senile o pre-senile
    4. Disponibilità ad interrompere l’uso di lenti a contatto per tutta la durata dello studio
    5. Disponibilità e capacità di seguire le procedure di studio
    6. Per le donne potenzialmente fertili, utilizzo di un metodo contraccettivo di elevata efficacia e disponibilità ad utilizzare tale metodo durante la partecipazione allo studio
    E.4Principal exclusion criteria
    1. Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations (e.g. ocular herpes, blepharitis, conjunctivitis, uveitis, keratitis, diabetic retinopathy, retinal vein occlusions, retinal vasculitis, retinal angiomatous proliferation, pseudoexfoliation syndrome, intraoperative floppy iris syndrome, etc.)
    2. Patients undergoing bilateral cataract surgery
    3. Patients under treatment with prostaglandin analogues or intravitreal injections of anti-VEGF (vascular endothelial growth factor) drugs
    4. Systemic diseases that may interfere with the results of the study (e.g. rheumatoid arthritis, Sjögren's syndrome, Behçet's disease, systemic lupus erythematosus, scleroderma with major ocular
    involvement, etc.)
    5. Any condition that could interfere with correct instillation of eye drops
    6. Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
    7. Monocular patients
    8. Visual Acuity (VA) < 20/80 in the contralateral eye
    9. Contraindication to ocular treatment with levofloxacin, tobramycin or dexamethasone
    10. Hypersensitivity to the study product or its excipients
    11. Participation in other studies in the last month
    before screening
    12. Pregnancy or breastfeeding
    1. Condizioni oculari che, a giudizio dello sperimentatore, possono interferire con le valutazioni di efficacia e/o di sicurezza (ad es. herpes oculare, blefarite, congiuntivite, uveite, cheratite, retinopatia diabetica, occlusione della vena retinica, vasculite retinica, proliferazione angiomatosa retinica, sindrome pseudoesfoliativa, sindrome intraoperatoria dell’iride a bandiera, ecc.)
    2. Pazienti sottoposti a intervento chirurgico di cataratta bilaterale
    3. Pazienti in trattamento con analoghi delle prostaglandine o iniezioni intravitreali di farmaci anti-VEGF (fattore di crescita endoteliale vascolare)
    4. Malattie sistemiche che possono interferire con i risultati dello studio (ad es. artrite reumatoide, sindrome di Sjögren, sindrome di Behçet, lupus eritematoso sistemico, sclerodermia con coinvolgimento oculare maggiore, ecc.)
    5. Qualsiasi condizione che possa interferire con la corretta instillazione di gocce oculari
    6. Intervento chirurgico oculare nell’occhio in studio (compresa la chirurgia laser) nei 3 mesi precedenti lo screening
    7. Pazienti monocoli
    8. Acuità visiva < 20/80 nell’occhio controlaterale
    9. Controindicazioni al trattamento oculare con levofloxacina, tobramicina o desametasone
    10. Ipersensibilità ai prodotti o ai loro eccipienti
    11. Partecipazione ad altri studi nel mese precedente lo screening
    12. Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients without signs of anterior chamber inflammation (sum of cells and flare score = 0).
    Proporzione di pazienti senza segni di infiammazione della camera oculare anteriore (punteggio relativo alla somma del numero di cellule e di flare = 0).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 14 days of treatment.
    Dopo 14 giorni di trattamento.
    E.5.2Secondary end point(s)
    Efficacy:
    - Incidence of endophthalmitis
    - Proportion of patients without signs of anterior ocular chamber inflammation
    - Conjunctival hyperemia
    - Total Ocular Symptoms Score (TOSS)
    - Ocular pain/discomfort
    - Use of rescue therapy; Safety and tolerability:
    - Intraocular pressure (IOP)
    - Visual acuity (ETDRS)
    - Adverse events
    - Global evaluation
    - Burning, stinging, blurred vision; Compliance:
    - Assessment of patient diary
    Efficacia:
    - Incidenza di endoftalmiti
    - Proporzione di pazienti senza segni di infiammazione della camera oculare anteriore
    - Iperemia congiuntivale
    - Punteggio totale dei sintomi oculari (Total Ocular Symptoms Score – TOSS)
    - Dolore/fastidio oculare
    - Utilizzo di terapia di emergenza ; Sicurezza e tollerabilità:
    - Pressione intraoculare (Intraocular Pressure – IOP)
    - Acuità visiva
    - Eventi avversi
    - Valutazione globale
    - Bruciore, sensazione pungente, visione offuscata ; Compliance:
    - Valutazione del diario paziente
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    - During treatment
    - After 3 and 7 days of treatment
    - After 3, 7 and 14 days of treatment
    - After 3, 7 and 14 days of treatment
    - After 3, 7 and 14 days of treatment
    - During treatment; Safety and tolerability:
    - After 3, 7 and 14 days of treatment
    - After 14 days of treatment
    - During treatment
    - After 3, 7 and 14 days of treatment
    - After 3, 7 and 14 days of treatment; Compliance:
    - After 3, 7 and 14 days of treatment
    Efficacia:
    - Durante il trattamento
    - Dopo 3 e 7 giorni di trattamento
    - Dopo 3, 7 e 14 giorni di trattamento
    - Dopo 3, 7 e 14 giorni di trattamento
    - Dopo 3, 7 e 14 giorni di trattamento
    - Durante il trattamento; Sicurezza e tollerabilità:
    - Dopo 3, 7 e 14 giorni di trattamento
    - Dopo 14 giorni di trattamento
    - Durante il trattamento
    - Dopo 3, 7 e 14 giorni di trattamento
    - Dopo 3, 7 e 14 giorni di trattamento; Compliance:
    - Dopo 3, 7 e 14 giorni di trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    valutatore in cieco
    blinded-assessor
    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 concerned57
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    Germany
    Italy
    Russian Federation
    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
    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 months9
    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 months9
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 800
    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)
    The patients will be managed according to standard routine practice applied by each center.
    I pazienti saranno trattati in accordo alla normale pratica clinica prevista da ciascun centro.
    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 Decision2018-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-19
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