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    Summary
    EudraCT Number:2012-002659-41
    Sponsor's Protocol Code Number:MOR208C201
    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 number2012-002659-41
    A.3Full title of the trial
    A Phase IIa, Open-Label, Multicenter Study of Single-Agent MOR00208, an
    Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory
    B-Cell Non-Hodgkin's Lymphoma
    Uno studio di fase IIa, in aperto, multicentrico di MOR00208 monoagente, un anticorpo anti-CD19 ottimizzato per Fc in pazienti affetti da linfoma non-Hodgkin a cellule B recidivante o refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIa, known-treatment without placebo, Multicenter Study of
    Single-Agent MOR00208, an Anti-CD19 Antibody, in Patients with Relapsed
    or Refractory B-Cell Non-Hodgkin's Lymphoma
    Uno studio di fase IIa, multicentrico, con un trattamento noto senza placebo, di MOR00208 monoagente, un anticorpo anti-CD19, in pazienti con linfoma non-Hodgkin a cellule B recidivante o refrattario
    A.4.1Sponsor's protocol code numberMOR208C201
    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 SponsorMORPHOSYS 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 supportMORPHOSYS AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMorphoSys AG
    B.5.2Functional name of contact pointClinical Program Lead Oncology
    B.5.3 Address:
    B.5.3.1Street AddressLENA-CHRIST-STR. 48
    B.5.3.2Town/ cityMARTINSRIED/PLANEGG
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone numberNA
    B.5.5Fax numberNA
    B.5.6E-mailinfo@morphosys.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 MOR00208
    D.3.4Pharmaceutical form Powder for 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.3.9.2Current sponsor codeMOR00208
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
    Linfoma non-Hodgkin a cellule B recidivante o refrattario
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
    linfoma non-Hodgkin a cellule B recidivante o refrattario
    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 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the antitumor activity of single-agent MOR00208 in adult
    patients with relapsed or refractory NHL who have received at least 1
    prior therapy containing rituximab as one of the treatments.
    1. Valutare l'attività antitumorale di MOR00208 monoagente in pazienti adulti con NHL recidivante o refrattario nel caso dei quali uno dei trattamenti precedentemente ricevuti sia almeno una terapia a base di rituximab.
    E.2.2Secondary objectives of the trial
    1. To evaluate the duration of response
    2. To establish safety and tolerability of MOR00208
    3. To assess the potential immunogenicity of MOR00208
    4. To evaluate the pharmacokinetics and pharmacodynamics of
    MOR00208 in patients with relapsed or refractory NHL
    1. Valutare la durata della risposta
    2. Stabilire sicurezza e tollerabilità di MOR00208
    3. Valutare la potenziale immunogenicità di MOR00208
    4. Valutare farmacocinetica e farmacodinamica di MOR00208 in pazienti con NHL recidivante o refrattario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients are male or female patients ≥ 18 years of age.
    2. Patients have a histologically-confirmed diagnosis according to the
    Revised European American lymphoma/World Health Organization
    (REAL/WHO) classification, of the following B-cell lymphomas :
    a. FL
    b. Other indolent NHL (eg, MZL/MALT)
    c. DLBCL
    d. MCL
    3. Patients' NHL must have progressed after at least 1 prior rituximabcontaining
    regimen.
    4. Patients have at least one site of measurable disease by magnetic
    resonance imaging (MRI) or computed tomography (CT) scan defined as
    at least one lesion that measures at least 1.5 × 1.5 cm, Exception: For
    patients with MCL only, patients with nonmeasurable disease but
    evaluable sites (bone marrow, spleen, peripheral blood, gastrointestinal
    tract) can be enrolled.
    5. Patients who have previously received an autologous stem cell
    transplantation must be at least 4 weeks post-transplant before study
    drug administration and must have exhibited a full haematological
    recovery
    6. Patients must have discontinued previous monoclonal antibody
    therapy (except rituximab) or radioimmunotherapy administration for at
    least 60 days before study drug administration.
    7. Patients should be off rituximab for at least 14 days before the
    screening visit and be confirmed to have either no response or have
    disease progression after rituximab treatment.
    8. Patients with DLBCL had a positive [18F]fluorodeoxyglucose-positron
    emission tomography (FDG-PET) scan at baseline(Cheson response
    criteria)
    9. Patients have a life expectancy of > 3 months.
    10. Patients must have an Eastern Cooperative Oncology Group (ECOG)
    performance status of < 3.
    11. Patients must meet the following laboratory criteria at screening:
    a. Absolute neutrophil count (ANC) ≥ 1.0 (1000/mm3)
    b. Platelet count ≥ 75 × 10E9/L without previous transfusion within 10
    days of first study drug administration
    c. Haemoglobin ≥ 8.0 g/dL (may have been transfused)
    d. Serum creatinine < 2.0 x upper limit of normal (ULN)
    e. Total bilirubin ≤ 2.0 × ULN
    f. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤
    2.5 × ULN.
    12. If a female of childbearing potential, a negative pregnancy test must
    be confirmed before enrolment and use of double-barrier contraception,
    oral contraceptive plus barrier contraceptive must be used during the
    study and for 3 months after the last dose, or confirmation of having
    undergone clinically documented total hysterectomy and/or
    oophorectomy, tubal ligation.
    13. If a male, an effective barrier method of contraception must be used
    during the study and for 3 months after the last dose if the patient is
    sexually active with a female of childbearing potential.
    14. The patients are able to comply with all study-related procedures,
    medication use, and evaluations.
    15. The patients are able to understand and give written informed
    consent and comply with the study protocol.
    1. I pazienti sono di sesso maschile o femminile di età ≥ 18 anni.
    2. I pazienti hanno una diagnosi istologicamente confermata secondo la classificazione Revised European American Lymphoma/Organizzazione Mondiale della Sanità (REAL/WHO) riguardo ai seguenti linfomi a cellule B:
    a. FL
    b. Altri NHL indolenti (ad es. MZL/MALT)
    c. DLBCL
    d. MCL
    3. Il linfoma non-Hodgkin dei pazienti deve aver registrato progressi a seguito di almeno 1 precedente regime contenente rituximab.
    4. I pazienti hanno almeno un sito di malattia misurabile attraverso imaging mediante risonanza magnetica (MRI) o tomografia assiale computerizzata (TAC) definito come almeno una lesione di almeno 1,5 × 1,5 cm.
    Eccezione:
    Per quanto riguarda i pazienti affetti da MCL, sarà possibile arruolare solo pazienti con siti di malattia non misurabili ma valutabili (midollo osseo, milza, sangue periferico, tratto gastrointestinale).
    5. I pazienti che sono stati previamente sottoposti a trapianto autologo di cellule staminali devono averlo subito da almeno 4 settimane prima di poter ricevere la somministrazione del farmaco e devono aver presentato un recupero ematologico completo
    6. I pazienti devono aver interrotto una precedente terapia con anticorpi monoclonali (eccetto nel caso di rituximab) o una precedente radioimmunoterapia per almeno 60 giorni prima di poter assumere il farmaco correlato allo studio.
    7. I pazienti dovrebbero aver interrotto l’assunzione di rituximab per almeno 14 giorni prima della visita di screening e deve essere confermata l’assenza di risposta o di progressione della malattia successivamente al trattamento con rituximab.
    8. I pazienti con DLBCL devono presentare una tomografia a emissione di positroni con [18F]fluorodesossiglucosio (FDG-PET) positiva al baseline (criteri di risposta Cheson)
    9. I pazienti hanno un’aspettativa di vita &gt; 3 mesi.
    10. I pazienti devono presentare uno stato di validità ECOG (Eastern Cooperative Oncology Group) &lt; 3.
    11. In sede di screening i pazienti devono soddisfare i seguenti criteri laboratoriali:
    a. Conta assoluta dei neutrofili (ANC) ≥1,0 (1000/mm3)
    b. Conta delle piastrine ≥ 75 × 109/l senza precedente trasfusione entro 10 giorni dalla prima somministrazione del farmaco sperimentale
    c. Emoglobina ≥ 8,0 g/dl (può essere stata trasfusa)
    d. Creatinina sierica &lt; 2,0 volte il limite superiore di normalità (ULN).
    e. Bilirubina totale ≤ 2,0 × ULN.
    f. Alanina transaminasi (ALT) e aspartato aminotransferasi (AST) ≤ 2,5 × ULN.
    12. Se la paziente è di sesso femminile in età fertile, prima dell’arruolamento è necessario vi sia la conferma di un test di gravidanza negativo e nel corso dello studio e per i 3 mesi successivi all’ultima assunzione sarà necessario l’utilizzo di dispositivi contraccettivi a doppia barriera, contraccettivi orali e contraccettivi a barriera, oppure deve essere prodotta una conferma circa il fatto che la paziente si è sottoposta a isterectomia totale clinicamente documentata e/o a ooforectomia, legatura delle tube.
    13. Se il paziente è di sesso maschile, è necessario il ricorso a un efficace metodo contraccettivo a barriera durante lo studio e nei 3 mesi successivi all’ultima dose nel caso in cui il paziente sia sessualmente attivo con un soggetto di sesso femminile in età fertile.
    14. I pazienti sono in grado di soddisfare tutte le procedure connesse allo studio, all’assunzione del farmaco e alle valutazioni.
    15. I pazienti sono in grado di comprendere e fornire consenso informato per iscritto, nonché di adempiere quanto specificato nel protocollo dello studio.
    E.4Principal exclusion criteria
    1. Previous treatment with cytotoxic chemotherapy, immunotherapy,
    radiotherapy or other lymphoma-specific therapy within 14 days before
    the screening visit or if patient has not recovered from side effects of
    previous lymphoma-specific therapy.
    2. Treatment with a systemic investigational agent within 28 days before
    the screening visit.
    3. Previous treatment with an anti-CD19 antibody or fragments
    4. Previous allogenic stem cell transplantation.
    5. Known or suspected hypersensitivity to the excipients contained in
    the study drug formulation.
    6. Clinically significant cardiovascular disease or cardiac insufficiency
    (New York Heart Association [NYHA] classes III-IV), cardiomyopathy,
    preexisting clinically significant arrhythmia, acute myocardial infarction
    within 3 months of enrolment, angina pectoris within 3 months of
    enrolment.
    7. Clinical or laboratory evidence of active hepatitis B (positive hepatitis
    B surface antigen [HBsAg] with negative hepatitis B surface antibody
    [HBsAb]) or hepatitis C (positive hepatitis C virus [HCV] antibody and
    detectable HCV ribonucleic acid [RNA] with ALT above the normal
    range).
    8. History of human immunodeficiency virus (HIV) infection.
    9. Any active systemic infection (viral, fungal, or bacterial) requiring
    active parenteral antibiotic therapy within 4 weeks of study drug
    administration.
    10. Current treatment with immunosuppressive agents other than
    prescribed corticosteroids (not more than 10-mg prednisone equivalent).
    11. Major surgery or radiation therapy within 4 weeks before first study
    drug administration.
    12. Systemic diseases (cardiovascular, renal, hepatic, etc) that would
    prevent study treatment in the investigator's opinion.
    13. History or clinical evidence of central nervous system (CNS),
    meningeal, or epidural disease, including brain metastasis.
    14. Active treatment/chemotherapy for another primary malignancy
    within the past 5 years (except for ductal breast cancer in situ, nonmelanoma
    skin cancer, prostate cancer not requiring treatment, and
    cervical carcinoma in situ).
    15. Pregnancy or breastfeeding in women and women of childbearing
    potential not using an acceptable method of birth control.
    16. History of noncompliance to medical regimens or patients who are
    considered potentially unreliable and not cooperative
    1. Precedente trattamento con chemioterapia citotossica, immunoterapia o con altra terapia specifica per i linfomi nel corso degli ultimi 14 giorni dalla visita di screening o mancato recupero dagli effetti collaterali di una precedente terapia specifica per la cura dei linfomi da parte del paziente.
    2. Trattamento con un farmaco sperimentale sistemico nel corso degli ultimi 28 giorni dalla visita di screening.
    3. Precedente trattamento con un anticorpo anti-CD19 o frammenti.
    4. Precedente trapianto di cellule staminali allogeniche.
    5. Nota o sospetta ipersensibilità agli eccipienti contenuti nella formulazione del farmaco sperimentale.
    6. Malattia cardiovascolare o insufficienza cardiaca (categorie NYHA (New York Heart Association) III IV), cardiomiopatia, preesistente aritmia clinicamente significativa, infarto miocardico acuto nel corso degli ultimi 3 mesi dall’arruolamento, angina pectoris nel corso degli ultimi 3 mesi dall’arruolamento.
    7. Evidenza clinica o laboratoriale di epatite B attiva (antigene di superficie dell’epatite B [HBsAg] positivo con anticorpo di superficie dell’epatite B [HBsAb]) negativo o epatite C (anticorpo del virus dell’epatite C [HCV] positivo e presenza di acido ribonucleico [RNA] dell’HCV con ALT al di sopra dei livelli normali).
    8. Anamnesi di infezione da virus dell’immunodeficienza umana (HIV).
    9. Qualsiasi infezione sistemica attiva (virale, fungina o batterica) che richieda una terapia antibiotica parenterale attiva nel corso delle ultime 4 settimane dalla somministrazione del farmaco sperimentale.
    10. Trattamento con agenti immunosoppressivi diversi dai corticosteroidi prescritti in corso (non più di 10-mg di equivalente del prednisone).
    11. Intervento di chirurgia maggiore o radioterapia nel corso delle ultime 4 settimane dalla somministrazione del farmaco sperimentale.
    12. Malattie sistemiche (di tipo cardiovascolare, renale, epatico, etc.) che secondo il giudizio dello sperimentatore ostacolerebbero i trattamenti dello studio.
    13. Anamnesi o evidenza clinica di malattie meningeali o epidurali del sistema nervoso centrale (SNC), inclusa la metastasi cerebrale.
    14. Trattamento attivo/chemioterapia per un’altra malignità primaria nel corso degli ultimi 5 anni (tranne che in caso di carcinoma mammario duttale in situ, carcinoma cutaneo non melanoma, carcinoma prostatico non richiedente trattamento e carcinoma cervicale in situ).
    15. Donne in stato di gravidanza o in fase di allattamento e donne in età fertile che non fanno uso di un metodo accettabile di controllo delle nascite.
    16. Anamnesi di mancata ottemperanza ai regime medici o pazienti considerate potenzialmente inaffidabili o non collaborativi.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) (complete remission [CR] + partial
    remission [PR]), assessed as per the 2007 International Working Group
    (IWG) response criteria
    1. Tasso di risposta complessivo (ORR) (remissione completa [CR] + remissione parziale [PR]), valutato in base ai criteri di risposta del Gruppo di Lavoro Internazionale (IWG) del 2007
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. After 40 patients
    2. After 80 patients
    1. Dopo 40 pazienti
    2. Dopo 80 pazienti
    E.5.2Secondary end point(s)
    1. Stable disease (SD), duration of response (DoR), time to progression
    (TTP), and progression-free survival (PFS)
    2. Incidence and severity of AEs
    3. Number and proportion of patients who potentially develop anti-
    MOR00208 antibodies and semiquantitative (anti-MOR00208 antibody
    titer determination of confirmed positive samples) anti-MOR00208
    antibody assessments
    4. Pharmacokinetics (apparent maximum serum concentration [Cmax],
    time to maximum serum concentration [tmax], apparent trough serum
    concentration before dosing [Cpd], area under the serum concentration
    versus time curve from time 0 to the time t of the last quantifiable
    concentration [AUC0-t], area under the serum concentration versus time
    curve from time 0 to infinity (extrapolated) [AUC0-∞], apparent terminal
    rate constant [λZ], apparent terminal half-life [t½], total body clearance
    [CL], volume of distribution during the terminal phase [Vz]), parameters
    determined using non-compartmental data analysis)
    5. Absolute and percentage change from baseline in measurements of Tand
    natural killer (NK) cell populations
    6. Evaluation of AEs and ORR stratified by baseline CD19 expression on
    malignant lymphoma cells
    7. Evaluation of AEs and ORR stratified by (FcγR)IIIa and FcγRIIa
    polymorphism
    1. Malattia stabile (SD), durata della risposta (DoR), tempo alla progressione (TTP), e sopravvivenza senza progressione (PFS)
    2. Incidenza e severità degli eventi avversi
    3. Numero e proporzione di pazienti che sviluppano potenzialmente anticorpi anti MOR00208 e valutazioni semiquantitative di anticorpi anti-MOR00208 (titolazione di anticorpi anti-MOR00208 di campioni positivi confermati)
    4. Farmacocinetica (massima concentrazione sierica apparente [Cmax], tempo alla massima concentrazione sierica [tmax], minima concentrazione sierica apparente prima del dosaggio [Cpd], area sottostante la curva temporale della concentrazione sierica rispetto al tempo dal tempo 0 al tempo t dell’ultima concentrazione quantificabile [AUC0-t], area sottostante la curva temporale della concentrazione sierica contro il tempo dal tempo 0 a infinito (estrapolata) [AUC0-∞], costante di velocità terminale apparente [λZ], emivita terminale apparente [t½], clearance totale [CL], volume di distribuzione durante la fase terminale [Vz]), parametri determinati ricorrendo a un’analisi non compartimentale dei dati)
    5. Variazione assoluta e percentuale dal baseline nelle misurazioni relative alle popolazioni di cellule T e natural killer (NK)
    6. Valutazione di eventi avversi e tasso di risposta complessivo stratificati per espressione di CD19 al baseline su cellule linfomiche maligne
    7. Valutazione di eventi avversi e tasso di risposta complessivo stratificati per polimorfismo di (FcγR)IIIa e FcγRIIa
    E.5.2.1Timepoint(s) of evaluation of this end point
    After end of study
    Dopo la fine dello studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 120
    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)
    No post-treatment provided by sponsor. The treating physician will decide upon adequate treatment of care
    Nessun post-trattamento fornito dallo sponsor. Il medico curante deciderà il trattamento di cura adeguato.
    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 Decision2012-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
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