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    Summary
    EudraCT Number:2015-000640-42
    Sponsor's Protocol Code Number:1199.222
    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:2018-02-22
    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 number2015-000640-42
    A.3Full title of the trial
    A twelve week, open-label, randomised, parallel-group study evaluating safety, tolerability and pharmacokinetics (PK) of oral nintedanib in
    combination with oral pirfenidone, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF)
    Studio di 12 settimane in aperto, randomizzato, a gruppi paralleli per valutare la sicurezza, la tollerabilità e la farmacocinetica (PK) della somministrazione orale di nintedanib in combinazione a pirfenidone confronto alla mono terapia con nintedanib, in pazienti con fibrosi polmonare idiopatica (IPF).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF
    Sicurezza, tollerabilità e farmacocinetica di nintedanib in combinazione con pirfenidone in IPF
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number1199.222
    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 SponsorBOEHRINGER-INGELHEIM ITALIA S.P.A.
    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 supportBoehringer Ingelheim Italia Spa
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number0018002430127
    B.5.5Fax number0018008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/3/13/1123
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.3Other descriptive namenintedanib
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Ofev
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/3/13/1123
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNintedanib
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.9.3Other descriptive nameNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    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.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 Esbriet
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/3/04/241
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIRFENIDONE
    D.3.9.1CAS number 53179-13-8
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive namePIRFENIDONE
    D.3.9.4EV Substance CodeSUB09907MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number267
    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
    Idiopathic Pulmonary Fibrosis
    fibrosi polmonare idiopatica
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis
    fibrosi polmonare idiopatica
    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 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial will be to assess safety and tolerability of
    combined treatment with nintedanib and pirfenidone
    Valutare la sicurezza e la tollerabilità del trattamento combinato con nintedanib e pirfenidone.
    E.2.2Secondary objectives of the trial
    A secondary objective is to assess the exposure, based on pharmacokinetic trough concentration values, to nintedanib either given alone or in combination with pirfenidone and to assess the assess the exposure of pirfenidone when combined with nintedanib
    Un obiettivo secondario è valutare - sulla base dei valori concentrazione della PK trough - il grado di esposizione a nintedanib, sia somministrato in mono-terapia sia in combinazione con pirfenidone e valutare grado di esposizione a pirfenidone in combinazione con nintedanib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent consistent with ICH-GCP and local laws,
    signed prior to any study procedures being performed (including any
    required washout)
    -Male or female patients aged greater than or equal to 40 years at visit 1
    -Idiopathic Pulmonary Fibrosis (IPF) diagnosis, based upon the
    ATS/ERS/JRS/ALAT 2011 guideline and confirmed by the investigator
    based on chest high resolution computed tomography (HRCT) scan
    performed within 12 months of visit 1
    -FVC greater than or equal to 50% of predicted normal at visit 1
    1. Firma del modulo di consenso informato in coerenza con le ICH-GCP prima di qualunque procedura di studio (inclusi i washout).
    2. Paziente uomo o donna >= 40 anni di età alla visita 1.
    3. Diagnosi di IPF sulla base della linea guida ATS/ERS/JRS/ALAT 20112011 e confermata dallo sperimentatore sulla base di scansione tomografica computerizzata del petto ad alta risoluzione (HRCT) effettuata entro 12 mesi dalla visita 1.
    4. FVC >= 50% del valore normale predetto alla visita 1.
    E.4Principal exclusion criteria
    -ALT, AST > 1.5 fold upper limit of normal (ULN) at visit 1
    -Total bilirubin > 1.5 fold ULN at visit 1
    -Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7)
    at visit 1
    -History of myocardial infarction within 6 months of visit 1 or unstable
    angina within 1 month of visit 1
    -Bleeding Risk: Known genetic predisposition to bleeding, Patients who
    require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
    antagonists, dabigatran, heparin, hirudin etc) or high dose antiplatelet
    therapy, History of haemorrhagic central nervous system event within 12
    months prior to visit 1, History of haemoptysis or haematuria, active
    gastro-intestinal bleeding or ulcers and/or major injury or surgery
    within 3 months prior to visit 1, International normalised ratio (INR) > 2
    at visit 1, Prothrombin time and partial thromboplastin time (PTT) >
    150% of
    institutional ULN at visit 1
    -Planned major surgery during the trial participation, including lung
    transplantation,major abdominal or major intestinal surgery.
    -History of thrombotic event (including stroke and transient ischemic
    attack) within 12
    months of visit 1
    -Severe renal impairment (Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault formula) or end-stage renal disease requiring dialisys.
    -Treatment with NAC, prednisone >15 mg daily or >30 mg every 2 days
    OR equivalent
    dose of other oral corticosteroids and/or fluvoxamine within 2 weeks of
    visit 2
    -Treatment with azathioprine, cyclophosphamide, cyclosporine as well as
    any other
    investigational drug within 8 weeks of visit 2
    -Previous treatment with pirfenidone
    -Permanent discontinuation of nintedanib in the past due to AEs
    considered drug-related
    -Known hypersensitivity to nintedanib, pirfenidone, peanut or soya or to
    any of the
    excipients
    -A disease or condition which in the opinion of the investigator may
    interfere with testing procedures or put the patient at risk when
    participating in this trial
    -Alcohol or drug abuse which in the opinion of the treating physician
    would interfere with treatment
    -Women who are pregnant, nursing, or who plan to become pregnant
    while in the trial.
    -Women of childbearing potential not willing or able to use highly
    effective methods of
    birth control per ICH M3 (R2) that result in a low failure rate of less than
    1% per year
    when used consistently and correctly5 for 28 days prior to and 3 months
    after nintedanib administration
    -Patients not able to understand and follow study procedures including
    completion of selfadministered questionnaires without help
    -Patients who require dose reduction and/or temporary interruption
    during the run-in period with nintedanib 150 mg bid
    1. ALT, AST > 1.5 volte superiori al limite di normalità (ULN) alla visita 11.
    2. bilirubina totale > 1.5 volte superiore all’ ULN alla visita 11.
    3. Ostruzione rilevante alle vie aeree (i.e. FEV1/FVC <0.7 pre-broncodilatatore) alla visita 1.
    4. Anamnesi di infarto del miocardio entro 6 mesi dalla visita 1 o angina instabile entro 1 mese dalla visita 1.
    5. Rischio di sanguinamento:
    -Nota predisposizione genetica al sanguinamento
    -Pazienti che richiedono fibrinolisi, dose piena di terapia anticoagulante (e.g.
    Antagonisti della vitamina K, dabigatran, eparina, irudina etc) o alti dosaggi di terapia anti-piastrinica.
    -Anamnesi di eventi emorragici correlati al sistema nervoso centrale entro 12 mesi prima della visita 1.
    -Anamnesi di emottisi o ematuria, sanguinamenti gastro intestinali attivi, o ulcere e/o danno grave o chirurgia maggiore entro 3 mesi prima della visita 1.
    -Tempo di protrombina e tromboplastina parziale (PTT) > 150% dell’ULN istituzionale alla visita 1.
    6. Chirurgia maggiore pianificata durante la partecipazione allo studio, incluso trapianto del polmone, chirurgia rilevante all’addome o all’intestino.
    7. Anamnesi di evento trombotico (incluso ictus e attacco ischemico transiente) entro 12
    mesi dalla visita 1.
    8. Anamnesi di patologia renale di stadio terminale che richiede dialisi Disfunzione renale di grado severo ( con .Creatinine clearance <30 mL/min calcolata con la formula di Cockcroft–Gault) oppure patologia renale di ultimo stadio che richieda dialisi.
    9. Trattamento con NAC, prednisone >15 mg al dì o >30 mg ogni 2 giorni O equivalente
    dose di altri corticosteroidi orali e/o fluvoxamina entro le 2 settimane dalla visita 2.
    10. Trattamento con azatrioprina, ciclofosfamide, ciclosporine e qualunque altro farmaco sperimentale entro le 8 settimane dalla visita 2.
    11. Trattamento pregresso con pirfenidone.
    12. Pregressa interruzione permanente di nintedanib per AEs considerati farmaco-correlati.
    13. Nota ipersensibilità a nintedanib, pirfenidone, arachidi o soia o qualunque altro eccipiente elencato nella section 4.1.1 del protocollo di studio.
    14. Patologia o condizione che a giudizio dello sperimentatore può interferire con le procedure dello studio o mettere a rischio il paziente qualora partecipi allo studio.
    15. Abuso di alcol o droghe che a giudizio del medico curante interferirebbero con il trattamento.
    16. Donne incinta, in allattamento o che pianifichino una gravidanza durante lo studio.
    17. Donne in età fertile non disposte o non in grado di utilizzare metodi efficaci di contraccezione in accordo alle ICH M3 (R2) che comportino un basso tasso di fallimento, inferiore all’ 1% per anno se utilizzati con consistenza e correttezza per 28 giorni prima e 3 mesi dopo l’assunzione di nintedanib.
    18. Pazienti non in grado di comprendere e seguire le procedure dello studio inclusi i questionari autosomministrati senza aiuto.
    19. Pazienti che richiedono riduzione del dosaggio e/o interruzione temporanea del nintedanib 150 mg bid durante il run-in.
    E.5 End points
    E.5.1Primary end point(s)
    1: The primary endpoint is the percentage of patients with on-treatment
    gastrointestinal (GI) AEs (SOC GI disorders) from baseline to week 12
    L’Endpoint Primario è la percentuale di pazienti in trattamento che hanno eventi avversi (AEs) gastrointestinali (SOC GI disorders) dal baseline alla settimana 12.
    Eventi avversi durante il trattamento sono definiti come AEs con insorgenza fin dal primo dosaggio del trattamento randomizzato e fino all’ultima dose (inclusa).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    1: Pre-dose plasma concentrations at steady state (Cpre,ss) of
    nintedanib at baseline, weeks
    2 and 4
    2: Pre-dose plasma concentrations at steady state (Cpre,ss) of
    pirfenidone at weeks 2 and 4.
    1) Concentrazioni plasmatiche pre-dose allo steady state (Cpre,ss) di nintedanib al baseline, alla settimana 2 e 4.
    2) Concentrazioni plasmatiche pre-dose allo steady state (Cpre,ss) di pirfenidone alle settimane 2 e 4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: baseline, week 2 and week 4
    2: week 2 and week 4
    1) basale, settimana 2 e settimana 4
    2) basale, settimana 2 e settimana 4
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 EEA21
    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
    Canada
    France
    Germany
    Italy
    Netherlands
    United States
    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 years1
    E.8.9.1In the Member State concerned months2
    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 months2
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 135
    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)
    Patients will be treated according to clinical practice
    I pazienti saranno tratti in accordo alla 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 Decision2015-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
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