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    Summary
    EudraCT Number:2011-002908-33
    Sponsor's Protocol Code Number:1301.2
    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:2012-10-30
    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 number2011-002908-33
    A.3Full title of the trial
    A randomized, double-blind, multi-center, multi-national Phase III trial to compare efficacy and safety of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular non-Hodgkin’s lymphoma.
    Sperimentazione randomizzata, in doppio cieco, multicentrica, multinazionale di fase III per confrontare l'efficacia e la sicurezza di BI 695500 più chemioterapia, rispetto a rituximab più chemioterapia, in pazienti con linfoma follicolare non-Hodgkin non trattato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BI 695500 safety and efficacy study in patients with untreated follicular non-Hodgkin's lymphoma.
    Studio della securezza e dell'efficacia di BI695500 in pazienti con linfoma follicolare non-Hodgkin non trattato
    A.4.1Sponsor's protocol code number1301.2
    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 INTERNATIONAL GMBH
    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 supportBoehringer Ingelheim International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co.KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBenger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1 800 243 0127
    B.5.5Fax number+1 800 821 7119
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNA
    D.3.2Product code BI 695500
    D.3.4Pharmaceutical form Concentrate for solution for injection/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.3.9.2Current sponsor codeBI 695500
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 typeanticorpo monoclonale
    D.IMP: 2
    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 MABTHERA*EV 2F 10ML 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 typeanticorpo monoclonale
    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 MABTHERA*EV 1FL 50ML 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 typeanticorpo monoclonale
    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
    Untreated stage III or IV non-Hodgkin's lymphoma (CD20+Follicular Lymphoma of Grade 1, 2 or 3, requiring chemotherapy)
    Linfoma non-Hodgkin (CD20+ FL di grado 1, 2 o 3a, che richiede chemioterapia) non trattato, in stadio III o IV
    E.1.1.1Medical condition in easily understood language
    Untreated non-Hodgkin's lymphoma
    Linfoma non-Hodgkin non trattato
    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 HLT
    E.1.2Classification code 10016903
    E.1.2Term Follicle centre lymphomas, follicular grade I, II, III
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: To compare the efficacy (best overall response rate [ORR] after completion of induction therapy) of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular lymphoma (FL).
    Obiettivo primario: Confrontare l’efficacia (migliore tasso di risposta complessivo [overall response rate, ORR] dopo completamento della terapia di induzione) di BI 695500 più chemioterapia, rispetto a rituximab più chemioterapia, in pazienti con linfoma follicolare (follicular lymphoma, FL) non trattato.
    E.2.2Secondary objectives of the trial
    Secondary objectives: • To assess progression free survival (PFS), time to treatment failure (TTF) and overall survival (OS). • To evaluate safety and immunogenicity. Exploratory objectives: • To evaluate the population pharmacokinetics (PPK). • To evaluate potential predictive biomarkers correlated with BI 695500 or rituximab response by analysis of plasma and tumor samples.
    Obiettivi secondari: • Verificare la sopravvivenza libera da progressione (progression free survival, PFS), il tempo al fallimento del trattamento (time to treatment failure, TTF) e la sopravvivenza complessiva (overall survival, OS). • Valutare la sicurezza e l’immunogenicità. Obiettivi esplorativi: • Valutare la farmacocinetica della popolazione (population pharmacokinetics, PPK). • Valutare i potenziali biomarcatori predittivi correlati con la risposta di BI 695500 o rituximab attraverso un’analisi di campioni di plasma e di tumore.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients, at least 18 years of age at Screening. 2.Untreated, histologically confirmed, stage III or IV NHL (CD20+Follicular Lymphoma of Grade 1, 2 or 3a, requiring chemiotherapy) 3. Patients not previously treated. Eligible patients previously on watch and wait (i.e. those patients who do not require treatment upfront at the time of the diagnosis)can enter the trial 4. ECOG performance status of 0 to 2. 5. Have a t least one measurable lesion as per the IWG criteria 2007 at Screening 6. Adequate hematological functions (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to randomization, including: • Hemoglobin ≥ 8,0 g/dL (≥ 5,0 mmol/L). • Absolute neutrophl count≥ 1,5 x 109/L. • Platelet count≥ 100 x 109/L. 7. Adequate renal and liver function. 8. For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial.
    1. Paziente di sesso maschile o femminile, con almeno 18 anni di età allo Screening 2. 3. LNH non trattato, istologicamente confermato, di stadio III o IV (LF CD20+ di Grado 1, 2 o 3a, che richieda chemioterapia). 3. 1. Pazienti non precedentemente trattati. I pazienti idonei precedentemente in stato di ''watch and wait'' (cioè, pazienti che non necessitavano di trattamento iniziale al momento della diagnosi) possono accedere alla sperimentazione 4. Performance status ECOG da 0 a 2. 5. 5. Presenza di almeno una lesione misurabile allo screening secondo i criteri IWG 2007 6. 6. Adeguata funzione ematologica (a meno che le anomalie non siano correlate a infiltrazione del linfoma nel midollo osseo) nei 28 giorni precedenti la randomizzazione, tra cui: • Emoglobina ≥ 8,0 g/dL (≥ 5,0 mmol/L). • Conta assoluta dei neutrofili ≥ 1,5 x 109/L. • Conta delle piastrine ≥ 100 x 109/L. 7. Adeguata funzione epatica e renale. 8. 7. Per i/le partecipanti con potenziale riproduttivo (maschi e femmine) è richiesto l'uso di un metodo contraccettivo accettabile dal punto di vista medico durante la sperimentazione
    E.4Principal exclusion criteria
    1. Transformation to high-grade lymphoma (secondary to low grade lymphoma). 2. Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis). 3. Patients regularly taking oral corticosteroids must not be receiving a dose exceeding 20 mg/day prednisolone or equivalent. 4. Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, idarubicin and /or other anthracyclines and anthracenediones. 5. Patients with prior or concomitant magignancies 6. Major surgery (excluding lymph node biopsy) within 28 days prior to randomization. 7. Poor renal function: serum creatinine > 2.0 mg/dL (> 197 mcmol/L). 8. Poor hepatic function: total bilirubin > 2.0 mg/dL (> 34 mcmol/L) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, unless these abnormalities are related to lymphoma. 9. Active, chronic or persistent infection that might worsen with immunosuppressive treatment 10. Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial 11. Patients with uncontrolled hypertension. 12. Known sensitivity or allergy to murine products. 13. History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug. 14. Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit. 15. Treatment within a clinical trial within 4 weeks prior to trial entry. 16. Pregnancy or breast feeding. For women of childbearing potential, a positive serum pregnancy test at the Screening Visit.
    1. Trasformazione in linfoma di alto grado (secondario al linfoma di basso grado). 2. Presenza o anamnesi di malattia a carico del sistema nervoso centrale (SNC) (linfoma del SNC o meningite linfomatosa). 3. Pazienti che assumono regolarmente corticosteroidi non possono assumere le dosi superiori a 20 mg/giorno di prednisolone o equivalente. 4. Trattamento precedente con le dosi cumulative massime di doxorubicina, daunorubicina, idarubicina e/o altre antracicline. 5. Pazienti con neoplasie precedenti o concomitanti. 6. Intervento chirurgico importante(esclusa la biopsia dei linfonodi) nei 28 giorni precedenti la randomizzazione. 7. Scarsa funzionalità renale:creatinina sierica &gt; 2,0 mg/dL (&gt; 197 mcmol/L). 8. Scarsa funzionalità epatica:bilirubina totale &gt; 2,0 mg/dL (&gt; 34 mcmol/L) o aspartato aminotransferasi (AST) &gt; 3 volte il limite superiore della norma, a meno che tali anomalie non siano correlate al linfoma. 9. Infezione attiva, cronica o persistente che potrebbe peggiorare a seguito di trattamento immunosoppressivo 10. Gravi condizioni mediche sottostanti, che potrebbero compromettere la capacità del paziente di partecipare alla sperimentazione. 11. Pazienti con ipertensione non controllata. 12. Nota sensibilità o allergia ai prodotti di origine murina. 13. Anamnesi di grave reazione allergica o anafilattica ad un agente biologico o anamnesi di ipersensibilità ad un componente del farmaco della sperimentazione. 14. Ricezione di vaccino vivo/attenuato nelle 12 settimane precedenti la visita di screening. 15. Trattamento nell'ambito di una sperimentazione clinica nelle 4 settimane precedenti l'accesso alla sperimentazione. 16. Gravidanza o allattamento al seno. Per le donne potenzialmente fertili, la presenza di test di gravidanza sul siero positivo alla visita di screening.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint • Best ORR (complete response [CR] + partial response [PR]) after completion of induction therapy as defined by the modified International Working Group (IWG) criteria 2007.
    Endpoint primario di efficacia • Migliore ORR (risposta completa [complete response, CR] + risposta parziale [partial response, PR]) dopo il completamento della terapia di induzione, per come definita dai criteri modificati dell’International Working Group (IWG), 2007.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments and Response assessment are performed after 3 cycles of induction treatment, at the end of induction therapy and every 6 month during maintainance therapy.The primary analysis will be performed after all patients have had tumor response assessments performed on completion of induction therapy or earlier if no patients are expected to complete induction therapy.
    Le valutazioni saranno eseguite dopo 3 cicli di terapia di induzione, alla fine della tarapia di induzione e ogni 6 mesi durante la terapia di mantenimento. L'analisi primaria(migliore risposta [complete response, CR] + risposta parziale [partial response, PR]sara eseguita quando tutti i pazient avranno completato la terapia di induzione, o prima, se nessun paziente sarà previsto di completare la terapia di induzione.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints • PFS, TTF, OS and immunogenicity. Pharmacokinetic/Exploratory endpoints • PPK from plasma concentrations of BI 695500 or rituximab sampled throughout the treatment period (total of four samples per patient) • Correlation between various biomarkers and clinical outcome parameters.
    Obiettivi secondari: • Verificare la sopravvivenza libera da progressione (progression free survival, PFS), il tempo al fallimento del trattamento (time to treatment failure, TTF) e la sopravvivenza complessiva (overall survival, OS). • Valutare la sicurezza e l’immunogenicità. Obiettivi esplorativi: • Valutare la farmacocinetica della popolazione (population pharmacokinetics, PPK). • Valutare i potenziali biomarcatori predittivi correlati con la risposta di BI 695500 o rituximab attraverso un’analisi di campioni di plasma e di tumore.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor assessments and Response assessment are performed after 3 cycles of induction treatment, at the end of induction therapy and every 6 month during maintainance therapy. Survival will be assesed throuhgout the trial from C1 to End of Maintainace visit. Anti.drug antibodies will be assese at C1, C4, C6 End of Induction, every 8 weeks during maintenance, at End of Maintenance visit. Timepoint for safety endpoint: Safety endpoints are checked at each study visit.
    Le valutazioni del tumore e della risposta tumorale saranno eseguite dopo 3 cicli di terapia di induzione, alla fine della tarapia di induzione e ogni 6 mesi durante la terapia di mantenimento. Sopravvivenza sarà valutata durante lo studio da C1 alla fine di terapia di mantenimento. Le valutazioni di anticorpi antifarmaco saranno eseguite durante C1, C4, C6, Fine di terapia di induzione, ongi 8 settimane durante la terapia di mantenimento, e durante la visita di Fine di terapia di mantenimento. Gli endpoint della sicurezza saranno valutati durante ogni visita 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 Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind 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) 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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA118
    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
    Chile
    Egypt
    Guatemala
    Hong Kong
    India
    Indonesia
    Malaysia
    Mexico
    New Zealand
    Panama
    Peru
    Philippines
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Sri Lanka
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Vietnam
    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
    Final analysis will be conducted when the last patient completes maintenance therapy or earlier
    L'analisi finale sarà eseguita quando l'ultimo paziente avrà completato la terapia di mantenimento o prima.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 530
    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 permanent discontinuation of trial medication patients may receive any subsequent treatment for their conditiion at the descretion of the investigator.
    Dopo aver discontinuato dal trattamento dello studio i pazienti potranno ricevere il trattamento per la loro condizione a discrezione del medico dello studio.
    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 Decision2012-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-09
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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