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    Summary
    EudraCT Number:2008-001087-36
    Sponsor's Protocol Code Number:12414
    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:2008-07-28
    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 number2008-001087-36
    A.3Full title of the trial
    A Phase III randomized, double-blind, placebo-controlled study of sorafenib as adjuvant treatment for hepatocellular carcinoma after surgical resection or local ablation.
    Studio di Fase III randomizzato, in doppio cieco, controllato con placebo, su sorafenib come trattamento adiuvante per l'epatocarcinoma in seguito a resezione chirurgica o ablazione locale.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM).
    Sorafenib come trattamento Adiuvante nella Prevenzione della Ricorrenza del Carcinoma Epatocellulare (STORM).
    A.3.2Name or abbreviated title of the trial where available
    STORM
    STORM
    A.4.1Sponsor's protocol code number12414
    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 SponsorBAYER HEALTHCARE AG
    B.1.3.4CountryGermany
    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 supportBayer Healthcare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer
    B.5.2Functional name of contact pointSabrina D`Angelo
    B.5.3 Address:
    B.5.3.1Street AddressVIALE CERTOSA 130
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.4Telephone number06 8548375
    B.5.6E-mailsabrina.dangelo@bayerhealthcare.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 NEXAVAR
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma AG
    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/3/06/364
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsorafenib
    D.3.9.1CAS number 284461-73-0
    D.3.9.2Current sponsor codeBAY-43-9006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HCC after receiving potentially curative treatment with surgical resection or local ablation
    Epatocarcinoma in seguito a resezione chirurgica o ablazione locale.
    E.1.1.1Medical condition in easily understood language
    Liver Cancer.
    Carcinoma epatico.
    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 LLT
    E.1.2Classification code 10024664
    E.1.2Term Liver cell carcinoma resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of HCC after potentially curative treatment with surgical resection or local ablation.
    Valutare il profilo di efficacia e sicurezza di sorafenib a confronto con il placebo nel trattamento adiuvante dell'epatocarcinoma in seguito al trattamento potenzialmente curativo con resezione chirurgica o ablazione locale.
    E.2.2Secondary objectives of the trial
    : Recurrence Free Survival (RFS) Secondary efficacy objectives: Time to Recurrence (TTR). Overall Survival (OS) Other objectives: Patient-Reported Outcome (PRO) as assessed by FACT-Hep and EQ-5D questionnaire. Evaluation of biomarkers.
    -Periodo di tempo fino alla ricorrenza,Sopravvivenza generale-Patient-Reported Outcome (PRO) valutato con i questionari FACT-Hep e EQ-5D,analisi dei biomarker e farmacocinetica.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENOMIC:
    Vers:3.0
    Date:2008/06/04
    Title:CLINICAL PHARMACOGENOMICS SUPPLEMENT Sorafenib as adjuvant treatment after curative resection/local ablation for hepatocellular carcinoma
    Objectives:The primary objective of this additional research component is to allow for the use of plasma samples already collected for other, non-genomic biomarker studies in Study 12414 to investigate possible associations between epigenetic, genetic or genomic variation in relation to response to sorafenib. Scientific information about these differences among groups of subjects can help researchers to better understand the response of subjects to sorafenib.

    FARMACOGENOMICA:
    Vers:3.0
    Data:2008/06/04
    Titolo:SUPPLEMENTO DI FARMACOGENOMICA CLINICA Sorafenib come trattamento adiuvante in seguito a resezione/ablazione locale curativa per l`epatocarcinoma
    Obiettivi:L`obiettivo principale di questa integrazione della ricerca e' quello di consentire l`impiego dei campioni plasmatici gia' prelevati per altri studi su biomarker non genomici nello Studio 12414 per studiare le possibili associazioni tra la variazione epigenetica, genetica o genomica in relazione alla risposta al sorafenib. Le informazioni scientifiche su queste differenze tra i gruppi di pazienti possono aiutare i ricercatori a comprendere meglio la risposta dei pazienti al sorafenib.

    E.3Principal inclusion criteria
    Inclusion criteria must be met at the time of screening unless otherwise specified. Informed consent must be obtained prior to commencing any study procedure. Confirmation of diagnosis of HCC: for subjects undergoing surgical resection histological confirmation is mandatory (a post surgery pathology report is required for both histological confirmation and risk stratification). for subjects undergoing local ablation either histological confirmation or clinical diagnosis by AASLD criteria (see Appendix 10.2) in cirrhotic subjects is required. For subjects without cirrhosis histological confirmation is mandatory. Prior to curative treatment, confirmation of a maximum tumor load of: single lesion any size for surgical resection, or single lesion ` 5cm (largest diameter, unidimensional measurement) for local ablation 2-3 lesions, each ` 3 cm in size (largest diameter, unidimensional measurement) Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period. At least 3 weeks (21 days) but not more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date. A timeframe of 4 weeks after surgical resection or last ablation is recommended. Male or female subjects > 18 years of age Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review. For subjects undergoing surgical resection pathology proven complete removal of tumor. Intermediate or High Risk of recurrence as assessed by tumor characteristics. Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites. ECOG Performance Status of 0. Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 14 days prior to screening: Hemoglobin > 9.0 g/dl Absolute neutrophil count (ANC) >1,500/mm3 Platelet count 50,000/-l Total bilirubin < 2 mg/dL ALT and AST < 5 x upper limit of normal Alkaline phosphatase £ 4 x ULN PT > 50% or PT-INR < 2.3, or < 6 seconds above control For subjects on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care. Serum creatinine < 1.5 x upper limit of normal Alpha fetoprotein < 400 ng/mL Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of treatment (assessed centrally). Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial. No more than 4 weeks (28 days ± 7 days) from the eligibility scan date (CT or MRI) to randomization.
    I criteri d`inclusione devono essere soddisfatti al momento dello screening salvo laddove diversamente specificato. Il consenso informato deve essere ottenuto prima di cominciare qualsiasi procedura prevista dallo studio. Conferma della diagnosi di epatocarcinoma: o per i pazienti che si sono sottoposti a resezione chirurgica e` obbligatoria la conferma istologica (e` necessario il referto dell`analisi patologica post intervento sia per la conferma istologica che per la stratificazione del rischio). o per i pazienti che si sono sottoposti ad ablazione locale e` richiesta alternativamente la conferma istologica oppure la diagnosi clinica in base ai criteri AASLD nei pazienti cirrotici. Per i pazienti senza cirrosi, e` obbligatoria la conferma istologica. Prima del trattamento curativo, conferma di un carico tumorale massimo di: o lesione singola di qualsiasi dimensione per la resezione chirurgica, oppure lesione singola ` 5 cm (diametro massimo, misurazione unidimensionale) per l`ablazione locale o 2-3 lesioni, ciascuna ` 3 cm (diametro massimo, misurazione unidimensionale) Pazienti che si sono sottoposti a resezione chirurgica o ablazione locale (PEI oppure RFA percutanea o intraoperatoria) per il trattamento dell`epatocarcinoma a scopo curativo in 4 mesi dalla stadiazione al trattamento potenzialmente curativo. Al massimo 2 cicli di ablazione locale possono essere somministrati in questo periodo di tempo. Almeno 3 settimane (21 giorni) ma non oltre le 7 settimane (49 giorni) dalla resezione o dall`ultimo ciclo di ablazione locale alla data della TC/RMN. Si consiglia un periodo di 4 settimane dopo la resezione chirurgica o l`ultimo ciclo di ablazione locale. Pazienti di sesso maschile o femminile &gt; 18 anni d`eta` Conferma della RC (assenza di tumore residuo dopo il trattamento curativo) alla scansione di eleggibilita` da parte della revisione radiologica indipendente. Per i pazienti che si sottopongono a resezione chirurgica, asportazione completa del tumore provata dall`analisi patologica. Rischio medio o alto di ricorrenza valutato in base alle caratteristiche del tumore. Punteggio Child-Pugh 5-7 punti. Un punteggio Child-Pugh di 7 punti e` consentito solo in assenza di ascite. Performance Status ECOG di 0. Funzione adeguata del midollo osseo, del fegato e dei reni esaminata dal laboratorio centrale ,valuatata secondo i seguenti parametri di laboratorio dei campioni prelevati entro 14 giorni prima della randomizzazione: o Emoglobina &gt; 9,0 g/dl o Conta assoluta dei neutrofili &gt; 1.500/mm3 o Conta piastrinica 50.000/-l o Bilirubina totale &lt; 2 mg/dl o ALT e AST &lt; 5 x limite superiore normale o Fosfatasi alcalina &lt; 4 x limite superiore normale o PT &gt; 50% oppure PT-INR &lt; 2,3, oppure &lt; 6 secondi sopra il controllo o I pazienti che assumono warfarin saranno sottoposti a stretto monitoraggio con esami almeno settimanali finche` l`INR risultera` stabile in base a una misurazione predose, come stabilito dalla pratica standard locale. o Creatininemia &lt; 1,5 x limite superiore normale Alfafetoproteina &lt; 400 ng/ml Le donne in eta` fertile devono sottoporsi a test di gravidanza su siero che dovra` risultare negativo entro 14 giorni prima dell`inizio del trattamento (determinato centralmente). Sia gli uomini che le donne selezionati per la sperimentazione dovranno usare adeguate misure contraccettive di barriera durante lo studio e per le due settimane successive al termine dello studio. Non piu` di 4 settimane (28 giorni ± 7 giorni) dalla data della scansione di eleggibilita` (TAC o RMN) alla randomizzazione.
    E.4Principal exclusion criteria
    Subjects who meet the following criteria at the time of screening will be excluded: Excluded medical conditions: Recurrent HCC Child-Pugh score 7 points with presence of ascites. The following tumor characteristics: a) Low risk of recurrence after curative treatment defined as any of the following: § for local ablation patients: single lesions < 2 cm § for surgical resection patients: single lesions < 2 cm without microscopic vascular invasion, without tumor satellites and histologically well differentiated. b) > 3 lesions or 2-3 lesions of which any > 3 cm in size (largest diameter, unidimensional measurement) prior curative treatment (surgical resection or local ablation) c) single lesion > 5 cm (largest diameter, unidimensional measurement) in size prior local ablation. d) Macrovascular invasion e) Extrahepatic spread (including regional lymph nodes and invasion into adjacent structures) History of cardiovascular disease: congestive heart failure >NYHA class 2 (Appendix 3) active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy( beta blockers or digoxin are permitted) uncontrolled hypertension. History of HIV infection Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0) Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics) History of organ allograft Subjects with evidence or history of bleeding diathesis Subjects undergoing renal dialysis Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry, as defined by the signing of informed consent. Uncontrolled ascites (defined as not easily controlled with diuretic treatment) Encephalopathy History of GI bleeding within 30 days of randomization. Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence. Excluded therapies and medications, previous and concomitant: Prior anti cancer therapy (including sorafenib or any other molecular therapy) is excluded. Major surgery within 4 weeks of start of study, as defined by the signing of informed consent, except for surgical resection or local ablation of HCC. Autologous bone marrow transplant or stem cell rescue within 4 months of study entry as defined by the signing of informed consent Use of biologic response modifiers, such as G-CSF, within 3 week of study entry, as defined by the signing of informed consent . Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent Pregnant or breast-feeding subjects. Substance abuse, medical, psychological or social conditions that may interfere with the subject s participation in the study or evaluation of the study results Known or suspected allergy to sorafenib. Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study Subjects unable to swallow oral medications. This applies to subjects with severe obstruction of the upper GI tract that require gavage.
    Saranno esclusi i soggetti che soddisfano i seguenti criteri allo screening: Epatocarcinoma ricorrente Punteggio Child-Pugh 7 punti in presenza di ascite. Caratteristiche del tumore di seguito: a) Basso rischio di ricorrenza dopo trattamento curativo inteso come una delle seguenti condizioni: § per i paz. sottoposti ad ablazione locale: lesioni singole &lt; 2 cm § per i paz. sottoposti a resezione chirurgica: lesioni singole &lt; 2 cm senza invasione vascolare microscopica, senza tumori satellite e ben differenziate dal punto di vista istologico. b) 3 lesioni oppure 2-3 lesioni delle quali una o piu` di dimensioni &gt; 3 cm (diametro massimo, misurazione unidimensionale) pregresso trattamento curativo (resezione chirurgica o ablazione locale) c) Lesione singola &gt; 5 cm (diametro massimo, misurazione unidimensionale) pregressa ablazione locale. d) Invasione vascolare macroscopica e) Diffusione extraepatica (compresi linfonodi regionali e invasione delle strutture adiacenti) Pregressa malattia cardiovascolare: insufficienza cardiaca congestiva &gt;NYHA classe 2 coronaropatia attiva (infarto del miocardio piu` di 6 mesi prima dell`ingresso in studio consentito); aritmie cardiache che richiedano terapia antiaritmica (betabloccanti o digossina consentiti) ipertensione non controllata. Pregressa infezione da HIV. Infezioni attive clinicamente gravi (&gt; grado 2 NCI-CTCAE versione 3.0) Paz. con disturbi convulsivi che richiedano terapia farmacologica (ad es. steroidi o antiepilettici) Pregresso omotrapianto d`organo. Paz. con segni o storia di diatesi emorragica.Paz. sottoposti a dialisi renale. Cancro precedente o concomitante diverso per sede primaria o caratteristiche istologiche dal cancro in studio AD ECCEZIONE DI carcinoma della cervice in situ, carcinoma basocellulare trattato, tumori superficiali della vescica [Ta, Tis e T1], oppure qualsiasi cancro curato &gt; 3 anni prima dell`ingresso in studio stabilito dal momento della firma del consenso informato. Ascite incontrollata(intesa come non facilmente controllata con la terapia diuretica). Encefalopatia Pregresso sanguinamento gastrointestinale nei 30 giorni precedenti la randomizzazione. Paz. con pregresso sanguinamento di varici esofagee che non e` stato seguito da una terapia efficace e/o trattamento per prevenire la ricorrenza del sanguinamento. Terapie e medicinali esclusi, precedenti e concomitanti: Pregressa terapia anti cancro per il trattamento dell epatocarcinoma (comprendente sorafenib o altra terapia molecolare) viene esclusa. Intervento di chirurgia maggiore nelle 4 settimane precedenti l`inizio dello studio stabilito dal momento della firma del consenso informato, ad eccezione della resezione chirurgica o dell`ablazione locale dell`epatocarcinoma. Trapianto di midollo osseo autologo oppure salvataggio con cellule staminali nei 4 mesi precedenti l`ingresso in studio stabilito dal momento della firma del consenso informato; Impiego di modificatori della risposta biologica, ad es. G-CSF, nelle 3 sett. precedenti l`ingresso in studio stabilito dal momento della firma del consenso informato. Terapia farmacologica sperimentale al di fuori di questo studio durante o nelle 4 sett. precedenti l`ingresso in studio stabilito dal momento della firma del consenso informato. Pazienti in gravidanza o allattamento. Abuso di sostanze, condizioni mediche, psicologiche o sociali che potrebbero interferire con la partecipazione del paz. allo studio o con la valutazione dei risultati dello studio. Allergia nota o sospetta al sorafenib.Qualsiasi condizione instabile o che potrebbe mettere a rischio la sicurezza del paz. e la sua capacita` di conformarsi ai requisiti dello studio. Paz. incapaci di deglutire medicinali orali.Questo vale paz. con grave ostruzione del tratto gastointestinale superiore che necessitano di alimentazione forzata con sonda
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is Recurrence Free Survival based on independent review; if the analysis based on Recurrence Free Survival is positive, then the efficacy of Sorafenib as adjuvant therapy of HCC is considered established.
    L'endpoint di efficacia primario e' la Sopravvivenza senza ricorrenza basata sulla revisione indipendente; se l'analisi basata sulla Sopravvivenza senza ricorrenza e' positiva, allora l'efficacia di Sorafenib come terapia adiuvante dell'epatocarcinoma si considera accertata.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the study protocol
    si prega di far riferimenot al protocollo
    E.5.2Secondary end point(s)
    Please refer to the study protocol
    Si prega di far riferimenot al protocollo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the study protocol
    Si prega di far riferimenot al protocollo
    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 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) 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 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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA150
    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
    Japan
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Russian Federation
    Singapore
    Switzerland
    Taiwan
    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
    The overall end of study for regulatory purposes is the date the last subject completes the end of study visit or records disease recurrence/death, whichever comes later.
    The overall end of study for regulatory purposes is the date the last subject completes the end of study visit or records disease recurrence/death, whichever comes later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 741
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 373
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1100
    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)
    see protocol (``Post Study Follow Up`` in chapter 4.7.5.5)
    see protocol (``Post Study Follow Up`` in chapter 4.7.5.5)
    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 Decision2008-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-28
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