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    Summary
    EudraCT Number:2010-024108-84
    Sponsor's Protocol Code Number:071001
    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:2012-03-01
    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 number2010-024108-84
    A.3Full title of the trial
    A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE
    Studio clinico di fase 3 per determinare la farmacocinetica, la sicurezza e l`efficacia di rVWF:rFVIII e rVWF nel trattamento di episodi emorragici in soggetti con diagnosi di malattia di von Willebrand
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to explore the pharmacokinetics, safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.
    Studio clinico per valutare la farmacocinetica, la sicurezza e l`efficacia di VWF ricombinante (in combinazione con FVIII ricombinante o da solo) nel trattamento di episodi emorragici in pazienti con malattia di von Willebrand.
    A.4.1Sponsor's protocol code number071001
    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 SponsorBAXTER INNOVATIONS GMBH
    B.1.3.4CountryAustria
    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 supportBaxter Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter Innovations GmbH
    B.5.2Functional name of contact pointDr. Guido Wuerth, Director ClinOps
    B.5.3 Address:
    B.5.3.1Street AddressWagramer Strasse 17 - 19
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1220
    B.5.3.4CountryAustria
    B.5.4Telephone number+43 1 20100 3489
    B.5.5Fax number+43 1 20100 717
    B.5.6E-mailguido_wuerth@baxter.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/10/814
    D.3 Description of the IMP
    D.3.1Product namerVWF
    D.3.2Product code BAX111
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNVonicog alfa
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number650
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.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 ADVATE (rAHF-PFM)
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter AG Austria
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNOCTOCOG ALFA
    D.3.9.1CAS number 139076-62-3
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB16449MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 placeboSolution for injection
    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
    Von Willebrand Disease
    Malattia di Von Willebrand
    E.1.1.1Medical condition in easily understood language
    Hereditary deficiency of Von Willebrand Factor in blood.
    Deficit congenito del Fattore di Von Willebrand nel sangue.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10047715
    E.1.2Term Von Willebrand's disease
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of pharmacokinetics (PK) of rVWF:rFVIII and rVWF and assessment of safety and efficacy of rVWF:rFVIII and rVWF in the treatment and prevention of bleeding events in subjects with severe hereditary VWD.
    Valutare la farmacocinetica (PK) di rVWF:rFVIII e rVWF, e valutare la sicurezza e l'efficacia di rVWF:rFVIII e rVWF nel trattamento e nella prevenzione di episodi emorragici in soggetti con MVW severa ereditaria
    E.2.2Secondary objectives of the trial
    • Compare PK parameters of rVWF alone or in combination with rFVIII in subjects with type 3 VWD • Examine PK parameters of rVWF in subjects with severe VWD or type 2N VWD • Evaluate hemostatic efficacy, safety, and tolerability of rVWF:rFVIII and rVWF in subjects with VWD receiving the investigational product for prevention and treatment of bleeding episodes • Evaluate tolerability and safety of rVWF including the development of inhibitory and total binding anti-VWF antibodies and clinically significant changes in laboratory parameters following drug administration • Assess changes in health-related quality of life (HRQoL)
    - Confrontare i parametri di farmacocinetica di rVWF somministrato da solo o in combinazione con rFVIII nei soggetti con MVW di tipo 3. - Esaminare i parametri di farmacocinetica di rVWF in soggetti con MVW severa o MVW di tipo 2N. - Valutare l`efficacia emostatica, la sicurezza e la tollerabilita' di rVWF:rFVIII e rVWF in soggetti con MVW che assumono il prodotto sperimentale per la prevenzione e il trattamento di episodi emorragici - Valutare la tollerabilita' e la sicurezza di rVWF compreso lo sviluppo di anticorpi inibitori e total binding anti-VWF e i cambiamenti clinicamente significativi nei parametri di laboratorio a seguito della somministrazione del farmaco. - Valutare i cambiamenti della qualita' della vita correlata allo stato di salute (HRQoL = healthrelated quality of life).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject has been diagnosed with: type 3 VWD (VWF: Ag ≤3 IU/dl) or severe non-type 3 VWD (VWF:RCo <20 IU/dL) or type 2N VWD (FVIII:C<10% and historically documented genetics) • Subject, who participates for the treatment for bleeding episodes, has had a minimum of 6 documented bleeds (medical history) requiring VWF coagulation factor replacement therapy during the previous 3 years prior to enrollment. • Subject has a Karnofsky score ≥60. • Subject is at least 18 and not older than 65 years of age at enrollment. • If female of childbearing potential, subject presents with a negative pregnancy test • The subject agrees to employ adequate birth control measures for the duration of the study. • Subject is willing and able to comply with the requirements of the protocol.
    •Il soggetto presenta una diagnosi di: MVW di tipo 3 (VWF:Ag ≤3 IU/dl) o MVW severa non di tipo 3 (VWF:RCo &lt;20 IU/dL) o MVW di tipo 2N (FVIII:C &lt;10% e genetica documentata) •Il soggetto, che partecipa al trattamento degli episodi di sanguinamento, ha avuto un minimo di 6 sanguinamenti documentati (anamnesi) che hanno richiesto una terapia sostitutiva con il fattore della coagulazione VWF nel corso degli ultimi 3 anni prima dell`arruolamento. •Il soggetto ha un punteggio Karnofsky ≥60. •Il soggetto al momento dell`arruolamento ha almeno 18 anni e non piu' di 65 anni. •Se di sesso femminile ed in eta' fertile, il soggetto presenta un test di gravidanza negativo •Il soggetto accetta di adottare adeguate misure contraccettive per tutta la durata dello studio. •Il soggetto e' in grado di intendere ed di attenersi ai requisiti del protocollo.
    E.4Principal exclusion criteria
    • Subject has been diagnosed with pseudo VWD or another hereditary or acquired coagulation disorder other than VWD (eg qualitative and quantitative platelet disorders or elevated PT/ international normalized ratio [INR] >1.4). • Subject has a documented history of a VWF:RCo half-life of <6 hours. • Subject has a history or presence of a VWF inhibitor at screening. • Subject has a history or presence of a factor VIII (FVIII) inhibitor with a titer ≥0.4 BU (by Nijmegen assay) or ≥0.6 BU (by Bethesda assay). • Subject has a known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins. • Subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies. • Subject has a medical history of a thromboembolic event. • Subject is HIV positive with an absolute CD4 count <200/mm3. • Subject has been diagnosed with cardiovascular disease (New York Heart Association [NYHA] classes 1-4). • Subject has an acute illness (eg, influenza, flu-like syndrome, allergic rhinitis/conjunctivitis, non-seasonal asthma) at screening. • Subject has been diagnosed with significant liver disease as evidenced by any of the following: serum alanine aminotransferase (ALT) 5 times the upper limit of normal; hypoalbuminemia; portal vein hypertension (eg, presence of otherwise unexplained splenomegaly, history of esophageal varices). • Subject has been diagnosed with renal disease, with a serum creatinine level ≥2 mg/dL. • In the judgment of the investigator, the subject has another clinically significant concomitant disease (eg, uncontrolled hypertension) that may pose additional risks for the subject. • Subject has been treated with an immunomodulatory drug, excluding topical treatment (eg,ointments, nasal sprays), within 30 days prior to signing the informed consent. • Subject is pregnant or lactating at the time of enrollment. • Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study. • Subject has a history of drug or alcohol abuse within the 2 years prior to enrollment. • Subject has a progressive fatal disease and/or life expectancy of less than 3 months. • Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures. • Subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude. • Subject is in prison or compulsory detention by regulatory and/or juridical order.
    -Il soggetto presenta una diagnosi di Pseudo MVW o altro disordine della coagulazione ereditario o acquisito diverso da MVW (ad esempio disordini piastrinici qualitativi e quantitativi o elevato PT/INR &gt;1.4). -Il soggetto ha un`anamnesi documentata di un`emivita VWF:RCo &lt;6 ore. -Il soggetto ha un`anamnesi o presenza di inibitori del VWF allo screening. -Il soggetto ha un`anamnesi o presenza di inibitori del fattore VIII (FVIII) con un titolo ≥0,4 BU (mediante metodo Nijmegen) o ≥0,6 BU (mediante metodo Bethesda). -Il soggetto ha ipersensibilita' nota a uno qualsiasi dei componenti dei farmaci studio, quali le proteine di topo o di criceto. -Il soggetto ha un`anamnesi di malattie immunologiche, escludendo rinite/congiuntivite allergiche stagionali , lieve asma, allergie alimentari o allergie animali. - Il soggetto ha un`anamnesi di eventi tromboembolici. - Il soggetto e' HIV positivo, con una conta CD4 assoluta &lt; 200/mm3. - Al soggetto e' stata diagnosticata malattia cardiovascolare (New York Heart Association [NYHA] classi 1-4). - Il soggetto ha una malattia acuta (ad esempio, influenza, sindrome simil-influenzale, rinite/congiuntivite allergica, asma non stagionale) al momento dello screening. - Al soggetto e' stata diagnosticata malattia epatica significativa, come evidenziato da uno dei seguenti parametri: alanina aminotransferasi sierica (ALT) 5 volte oltre il limite superiore alla norma; ipoalbuminemia; ipertensione della vena porta (ad esempio, presenza di splenomegalia altrimenti inspiegabile, anamnesi di varici esofagee) . - Al soggetto e' stata diagnosticata malattia renale, con un livello di creatinina sierica ≥2 mg/dL. - A giudizio dello sperimentatore, il soggetto soffre di altra malattia concomitante clinicamente significativa (ad esempio, ipertensione non controllata) che potrebbe causare ulteriori rischi al soggetto. - Il soggetto e' stato trattato con un farmaco immunomodulatore, escludendo il trattamento topico (ad esempio, unguenti, spray nasali), nei 30 giorni precedenti alla firma del consenso informato. - Il soggetto e' in stato di gravidanza o sta allattando al momento dell’arruolamento - Il soggetto ha partecipato a un altro studio clinico che prevedeva l’uso di un prodotto sperimentale o di un dispositivo sperimentale nei 30 giorni precedenti l’arruolamento o durante questo studio intende partecipare a un altro studio clinico che prevede un prodotto sperimentale o un dispositivo sperimentale. - Il soggetto ha un`anamnesi di abuso di droga o alcool nei 2 anni precedenti l`arruolamento. - Il soggetto presenta malattia progressiva con esito fatale e/o aspettativa di vita inferiore a 3 mesi. - Lo sperimentatore ha identificato l`incapacita' o la non volonta' del soggetto a cooperare con le procedure dello studio. - Il soggetto soffre di una condizione mentale che lo/la rende incapace di comprendere la natura, lo scopo e le possibili conseguenze dello studio, e/o evidenza di atteggiamento non collaborativo. - Il soggetto e' in prigione o in detenzione obbligatoria per provvedimento normativo e/o giudiziario.
    E.5 End points
    E.5.1Primary end point(s)
    Number of subjects with treatment success for treated bleeding episodes.
    Numero di soggetti con successo terapeutico per gli episodi emorragici trattati
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall clinical efficacy rating within 24 hrs of resolution of bleed by investigator. Home treatments will be evaluated at each study visit. Analysis of efficacy will be performed after each study part.
    Punteggio della completa efficacia clinica entro 24 ore dalla risoluzione del sanguinamento, valutato dallo Sperimentatore. I trattamenti effettuati a casa verranno valutati ad ogni visita al centro. L`analisi di efficacia sara' eseguita al termine di ciascuna parte dello studio.
    E.5.2Secondary end point(s)
    Efficacy • Number of treated bleeding episodes with an efficacy rating of `excellent` or `good` • Number of infusions and rVWF:rFVIII and/or rVWF units per bleeding episode. Safety • Development of inhibitory and total binding anti-VWF antibodies • Development of inhibitory antibodies to FVIII • Development of antibodies to Chinese hamster ovary (CHO) proteins, mouse immunoglobulin G (IgG) and rFurin • Occurrence of thrombotic events • Other IP related AEs, such as clinically significant changes in routine laboratory parameters (hematology and clinical chemistry) and vital signs Pharmacokinetic • Area under the plasma concentration/time curve from time 0 to infinity (AUC0-∞/Dose); area under the plasma concentration/time curve from time 0 to 96 hours (AUC0-96h/Dose); mean residence time (MRT); clearance (CL); incremental recovery (IR), elimination phase half-life (T1/2); volume of distribution at steady state (Vss) of VWF Ristocetin cofactor (VWF:RCo), VWF antigen (VWF:Ag), VWF collagenbinding (VWF:CB), and FVIII. • In vivo recovery (IVR) of VWF:RCo, VWF:Ag and VWF:CB. • Comparison of intra-subject PK of VWF:RCo, VWF:CB and VWF:Ag at baseline and after 6 months in a subset of at least 20 subjects with severe VWD (minimum 6 subjects with type 3 VWD). Exploratory Endpoints: • Generic: Physical Component Score (PCS) and Mental Component Score (MCS) of the Short Form-36 (SF-36) • Disease-specific: Total score of the unvalidated von Willebrand Disease Impact Questionnaire
    Efficacia: -Numero di episodi emorragici trattati con grado di efficacia `ottimo` o `buono` -Numero di infusioni e unita' di rVWF:rFVIII e/o rVWF per episodio emorragico. Sicurezza: -Sviluppo di anticorpi inibitori e total binding anti-VWF - Sviluppo di anticorpi inibitori anti-FVIII - Sviluppo di anticorpi contro le proteine delle cellule ovariche di criceto cinese (CHO), contro le immunoglobuline G (IgG) murine e contro rFurin - Verificarsi di eventi trombotici - Altri eventi avversi correlati al prodotto sperimentale, quali variazioni clinicamente significative dei parametri di laboratorio di routine (ematologia e chimica clinica) e dei segni vitali. Farmacocinetica: - Area sotto la curva concentrazione plasmatica/tempo dal tempo 0 ad infinito (AUC0-∞/dose); area sotto la curva concentrazione plasmatica/tempo dal tempo da 0 a 96 ore (AUC0-96h/Dose); tempo medio di permanenza (MRT); clearance (CL); recupero incrementale (IR), emivita della fase di eliminazione (T1/2); volume di distribuzione allo stato stazionario (Vss) del cofattore ristocetina VWF (VWF:RCo), dell’antigene VWF (VWF:Ag), del VWF legato al collagene (VWF:CB), e FVIII. - Recupero in vivo (IVR) di VWF:RCo, VWF:Ag e VWF:CB. - Confronto della farmacocinetica intra-soggetto di VWF:RCo, VWF:CB e VWF:Ag alla baseline e dopo 6 mesi in un sottogruppo di almeno 20 soggetti affetti da VWD grave (minimo 6 soggetti con VWD di tipo 3). Endpoint esplorativi: • Generici: punteggio componente fisica (PCS) e punteggio componente mentale (MCS) dello Short Form-36 (SF-36) • Specifici della malattia: punteggio totale del questionario non validato sull`impatto della malattia di Von Willebrand
    E.5.2.1Timepoint(s) of evaluation of this end point
    After each study part.
    Dopo ciascuna parte dello studio
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    In aperto, eccetto il braccio PK50 (in cieco)
    Open-label, except for PK50 arm (double blinded)
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    India
    Japan
    United States
    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
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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: 40
    F.1.3Elderly (>=65 years) No
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    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)
    After the end of the clinical trial, the patients will receive the required standard therapy, as assessed by their treating physician.
    Dopo la fine dello studio clinico, i pazienti riceveranno la terapia standard richiesta, sulla base della valutazione del medico curante.
    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 Decision2011-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-15
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