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    Summary
    EudraCT Number:2008-005872-29
    Sponsor's Protocol Code Number:MORAb-003-004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-05-05
    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 number2008-005872-29
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse
    Studio randomizzato, in doppio cieco, controllato verso placebo, di fase 3 per valutare efficacia e sicurezza di Farletuzumab (MORAb-003) settimanale in combinazione con Carboplatino e Taxano in soggetti con tumore ovarico Platino-sensibile alla prima recidiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
    Valutare l`efficacia e la sicurezza MORAb-003 in soggetti con tumore ovarico Platino-sensibile alla prima recidiva
    A.4.1Sponsor's protocol code numberMORAb-003-004
    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 SponsorEisai Limited
    B.1.3.4CountryUnited Kingdom
    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 supportEisai Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEisai Limited
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressEuropean Knowledge Centre, Mosquito Way
    B.5.3.2Town/ cityHatfield, Hertfordshire
    B.5.3.3Post codeAL10 9SN
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0208 600 1400
    B.5.5Fax number+44 0208 600 1401
    B.5.6E-mailLMedInfo@eisai.net
    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/3/08/535
    D.3 Description of the IMP
    D.3.1Product nameFarletuzumab
    D.3.2Product code MORAb-003
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFarletuzumab
    D.3.9.1CAS number 896723-44-7
    D.3.9.2Current sponsor codeMORAb-003
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 5.5
    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 Yes
    D.3.11.13.1Other medicinal product typemAb umanizzato verso il recettore alfa del folato
    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 infusion
    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
    Prima recidiva di carcinoma ovarico epiteliale non mucinoso platino-sensibile incluso carcinoma peritoneale primario o tumore delle tube di falloppio
    First relapse of platinum-sensitive non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    Carcinoma ovarico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033160
    E.1.2Term Ovarian epithelial cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of two dose levels of MORAb-003 or placebo in combination with carboplatin and taxane on progression-free survival (PFS) as determined by RECIST, in subjects with platinum-sensitive ovarian cancer in first relapse.
    Valutare l`effetto di due livelli di dosaggio di MORAb-003 o placebo associati a carboplatino e taxano sulla sopravvivenza libera da progressione (PFS) come definito da RECIST, in soggetti con carcinoma ovarico platino-sensibile alla prima recidiva.
    E.2.2Secondary objectives of the trial
    -To assess the effect of MORAb-003 on overall survival (OS) (key secondary objective) -To assess the effect of MORAb-003 on CA-125 defined PFS and serologic response, based on Rustin criteria -To assess the effect of MORAb-003 to prolong second remission longer than first remission -To assess the effect of MORAb-003 on best objective response (OR) rate, time to response (TTR) and duration of response (DR) by RECIST criteria -To compare the serologic response of low- (1.25 mg/kg) and high- (2.5 mg/kg) dose MORAb-003 to each other in combination with carboplatin and taxane, and to placebo plus carboplatin and taxane -To assess the safety and tolerability of both dose levels of MORAb-003 -To assess the effect of MORAb-003 on subject-reported on Quality of Life (QoL) -To assess the effect of MORAb-003 on resource utilization
    -Valutare l effetto di MORAb-003 sulla OS-Valutare l effetto di MORAb-003 sulla PFS definita da CA-125 e sulla risposta sierologica,in base ai criteri Rustin-Valutare l effetto di MORAb-003 nel prolungamento dei tempi della seconda remissione rispetto ai tempi della prima remissione-Valutare l effetto di MORAb-003 sul miglior tasso di risposta oggettiva (OR),tempo di risposta (TTR) e durata della risposta (DR) secondo i criteri RECIST-Confrontare la risposta sierologica di un basso dosaggio (1,25 mg/kg) e di un dosaggio elevato (2,5 mg/kg) di MORAb-003 associato a carboplatino e taxano,e al placebo piu` carboplatino e taxano-Valutare la sicurezza e la tollerabilita` di entrambi i livelli di dosaggio di MORAb-003-Valutare l effetto di MORAb-003 sulla Qualita` della vita-Valutare l`effetto di MORAb-003 sull`uso delle risorse
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:2
    Date:2009/02/02
    Title:A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in Subjects with Platinumsensitive Ovarian Cancer in First Relapse
    Objectives:To determine if a pharmacokinetic interaction exists between MORAb- 003 and carboplatin, paclitaxel, or docetaxel with a PK drug-drug interaction (DDI) sub-study

    FARMACOCINETICA/FARMACODINAMICA:
    Vers:2
    Data:2009/02/02
    Titolo:Studio randomizzato, in doppio cieco, controllato verso placebo, di fase 3 per valutare efficacia e sicurezza di Farletuzumab (MORAb-003) settimanale in combinazione con Carboplatino e Taxano in soggetti con tumore ovarico Platino-sensibile alla prima recidiva
    Obiettivi:Valutare se esiste un`interazione fra livelli di MORAb-003, carboplatino, paclitaxel o docetaxel. Circa 90 soggetti verranno arruolati in un sottostudio PK DDI.

    E.3Principal inclusion criteria
    1.Female subjects ¥18 years of age 2.Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. Contraceptive measures must start either prior to or at screening and continue throughout the entire study period and for 2 months after the last dose of study drug is administered. Pregnant and/or lactating females are excluded 3.A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies 4.Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy 5. Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed 6.Must have measurable disease by CT or MRI scan 7.Must have relapsed radiologically with a randomization date within ¥6 and ` 24 months of completion of firstline platinum/taxane chemotherapy 8.Must be a candidate for repeat carboplatin and taxane therapy 9.Life expectancy of ¥6 months as estimated by the investigator 10.Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1 11.Karnofsky performance status (KPS) ¥70% 12.Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows: Absolute neutrophil count (ANC) ¥ 1.5 x 10*9/L Platelet count ¥ 100 x 10*9/L Hemoglobin ¥ 9 g/dL Creatinine `1.5x ULN (CTCAE Grade 1)Bilirubin < 1.5x ULN (CTCAE Grade 1) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase < 2.5 x ULN (CTCAE Grade 1) 13.Neurologic function: neuropathy (sensory and motor) `CTCAE Grade 1 14.Subject must provide written informed consent and be able to comply with the protocol procedures (*=to the power)
    1.Soggetti di sesso femminile `‰¥18 anni di eta` 2.I soggetti in età fertile devono essere chirurgicamente sterili o acconsentire all`uso di un metodo contraccettivo accettabile nel corso dell'intero periodo dello studio. Le misure contraccettive devono iniziare prima o al momento dello screening e proseguire nell`arco dell`intero periodo dello studio e per 2 mesi dopo che è stata somministrata l`ultima dose di farmaco dello studio. Le donne in gravidanza e/o in allattamento sono escluse 3.Una diagnosi istologicamente o citologicamente confermata di carcinoma ovarico epiteliale non mucinoso, inclusi tumori maligni peritoneali primari o delle tube di Falloppio. 4.Essere stati sottoposti a debulking chirurgico e a chemioterapia a base di platino e taxano di prima linea. 5.consentito un precedente mantenimento con bevacizumbab. L`ultima dose di bevacizumab deve essere stata assunta almeno 30 giorni prima del Giorno 1 dello studio. Non è consentita alcuna terapia di mantenimento citotossica (ad es. taxano) o terapia vaccinale antitumorale. 6.Devono essere affetti da patologia misurabile da TC o RM 7.Devono presentare recidiva radiologicamente confermata con una data di randomizzazione compresa tra ¥6 e &lt; 24 mesi dal completamento della chemioterapia di prima linea con platino 8.Devono essere candidati per una terapia con carboplatino e taxano 9.Aspettativa di vita `‰¥6 mesi secondo la stima dallo sperimentatore 10.Altre condizioni mediche significative devono essere ben controllate e stabili secondo l`opinione dello sperimentatore per almeno 30 giorni antecedenti al Giorno 1 dello studio 11.Scala di Karnofsky (KPS) `‰¥70% 12.Risultati di laboratorio e risultati clinici nelle 2 settimane precedenti al Giorno 1 dello studio come di seguito: Conta assoluta dei neutrofili (ANC) `‰¥1,5 x 10^9/l, Conteggio piastrinico `‰¥100 x 10^9/l, Emoglobina `‰¥9 g/dl, Creatinina &lt;1,5x ULN (CTCAE grado 1), Bilirubina &lt; 1,5x ULN (CTCAE grado 1), Aspartato aminotransferasi (AST), alanina aminotransferasi (ALT) e fosfatasi alcalina &lt; 2,5 x ULN (CTCAE grado 1) 13.Funzione neurologica: neuropatia (sensoriale e motoria) `‰¤ CTCAE grado 1 14.Il soggetto deve fornire un consenso informato scritto ed essere in grado di attenersi alle procedure del protocollo
    E.4Principal exclusion criteria
    1. Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy 2. Subjects who have received other therapy to treat their ovarian cancer since relapse 3. Known central nervous system (CNS) tumor involvement 4. Evidence of other active invasive malignancy requiring treatment in the past 5 years 5. Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months) 6. Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible) 7. Active serious systemic disease, including active bacterial or fungal infection 8. Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary. 9. Other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed) 10. Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA 11. Previous treatment with MORAb-003 (farletuzumab) 12. Clinical contraindications to use of a taxane 13. Prior treatment with any investigational agent within 4 weeks of study entry 14. Breast-feeding, pregnant, or likely to become pregnant during the study
    1. Soggetti che non hanno mai risposto alla terapia di prima linea basata su platino o la cui prima recidiva ha luogo &lt;6 mesi o &gt;24 mesi dopo l`ultima terapia basata su platino 2. Soggetti che hanno ricevuto una diversa terapia per il trattamento del carcinoma ovarico dalla recidiva 3. Sviluppo noto del tumore nel sistema nervoso centrale (CNS) 4. Evidenza di altro tumore maligno invasivo attivo che ha richiesto un trattamento negli ultimi 5 anni 5. Malattia cardiaca clinicamente significativa (vale a dire, insufficienza cardiaca congestizia di classe 3 o 4 secondo la New York Heart Association, angina non ben controllata tramite trattamento medico o infarto miocardico entro 6 mesi) 6. Elettrocardiogramma (ECG) che dimostri aritmie clinicamente significative (Nota: I soggetti con aritmia atriale cronica, vale a dire fibrillazione atriale o tachicardia sopraventricolare parossistica [SVT] sono idonei) 7. Malattia sistemica seria attiva, inclusa infezione batterica o fungina attiva 8. Infezione da epatite virale attiva o virus dell`immunodeficienza umana attivo (HIV). La sierologia asintomatica positiva non e` motivo di esclusione. 9. Altra immunoterapia concomitante (vale a dire, immunosoppressori o utilizzo cronico di corticosteroidi sistemici, ad eccezione dei corticosteroidi a bassa dose, che sono consentiti) 10. Reazione allergica nota a una precedente terapia con anticorpi monoclonali o HAHA documentata 11. Precedente trattamento con MORAb-003 (farletuzumab) 12. Controindicazioni cliniche all`uso di taxano 13. Precedente trattamento con farmaco sperimentale entro 4 settimane dall`ingresso nello studio 14. Donne che allattano al seno, donne incinte o donne che potrebbero rimanere incinte durante lo studio
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) is the primary efficacy endpoint, defined as the time from randomization to progression by RECIST (as measured using independent review of CT/MRI scans as outlined in the Central Radiology Charter and Statistical Analysis Plan), or death from all causes.
    L`endpoint primario di efficacia è la sopravvivenza libera da progressione (PFS) definita come il tempo dalla randomizzazione alla progressione secondo RECIST (basata su valutazioni radiologiche centrali e indipendenti come evidenziato dal Central Radiology Charter and Statistical Analysis Plan) o morte per tutte le cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    English PFS is defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (RECIST), or date of death, whatever the cause.
    PFS è definita come il tempo (in mesi) dalla data della randomizzazione alla data della prima osservazione di progressione basata sulla valutazione radiologica indipendente (RECIST) o fino alla data del decesso, qualunque sia la causa.
    E.5.2Secondary end point(s)
    English Overall Survival (OS); CA-125 PFS (Rustin Criteria); GCIG PFS (GCIG Criteria); Tumor Response (OR, TTR, DR per RECIST); Serologic Response (CA-125); length of first versus second remission; Subjectreported Quality of Life (QoL); and Resource utilization [hospitalizations (inpatient or outpatient, length of stay), unscheduled office visits, and admission to hospice or nursing home]
    Sopravvivenza complessiva (OS); CA-125 PFS (Criteri Rustin); GCIG PFS (Criteri GCIG); Risposta al Tumore (OR, TTR, DR per RECIST); Risposta Sierologica (CA-125); durata della prima remissione rispetto alla seconda; Qualità della vita (QoL) rilevata dal soggetto (QOL); utilizzo delle risorse [ospedalizzazioni (paziente ricoverato o prestazione ambulatoriale, durata della permanenza), visite non programmate e ricovero presso ospizio o casa di cura]
    E.5.2.1Timepoint(s) of evaluation of this end point
    English OS is defined as the time from the date of randomization to the date of death, due to all causes. If death is not observed for a subject, the survival time will be censored on the last date known to be alive or the cut-off date, whichever is earliest. CA-125 PFS is defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. GCIG PFS is defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the GCIG criteria, or date of death, whatever the cause.
    OS è definito come il tempo dalla data di randomizzazione alla data di decesso, per qualsiasi causa. Se non si verifica decesso in un soggetto, il tempo di sopravvivenza sarà valutato sulla base dell`ultima data conosciuta relativa alla sopravvivenza o della data di sospensione, comunque precedente. CA-125 PFS è definito come il tempo (in mesi) dalla data della randomizzazione alla data della prima osservazione di progressione basato sui criteri Rustin, o data del decesso, qualsiasi sia la causa. GCIG PFS è definito come il tempo (in mesi) dalla data della randomizzazione alla data della prima osservazione di progressione basato sui criteri GCIG, o data del decesso, qualsiasi sia la causa.
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned28
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA143
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    China
    Hong Kong
    India
    Israel
    Japan
    Korea, Republic of
    Philippines
    Russian Federation
    Singapore
    Switzerland
    Taiwan
    Ukraine
    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 years0
    E.8.9.1In the Member State concerned months65
    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 months65
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 720
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 518
    F.4.2.2In the whole clinical trial 1080
    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)
    -
    -
    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 Decision2009-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-01-10
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