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    Summary
    EudraCT Number:2012-002659-41
    Sponsor's Protocol Code Number:MOR208C201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-09
    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 ConcernedSpain - AEMPS
    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
    Estudio multicéntrico abierto de fase IIa sobre el uso en monoterapia de MOR00208, un anticuerpo anti-CD19 con optimización del dominio Fc, en pacientes con linfoma no-Hodgkin de células B recidivante o refractario
    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
    Estudio multicéntrio de fase IIa sobre el uso de un fármaco conocido sin placebo en monoterapia de MOR00208, un anticuerpo anti-CD19, en pacientes con linfoma no-Hodgkin de células B recidivante o refractario
    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-Strasse 48
    B.5.3.2Town/ cityMartinsried/Planegg
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    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.3.2Product code MOR00208
    D.3.4Pharmaceutical form Lyophilisate 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.3.8INN - Proposed INNno INN assigned
    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 no-Hodgkin de células B recidivante o refractario
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory B-Cell Non-Hodgkin?'s Lymphoma
    Linfoma no-Hodgkin de células B recidivante o refractario
    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 one prior therapy containing rituximab as one of the treatments.
    Evaluar la actividad antitumoral de MOR00208 en monoterapia en pacientes adultos con LNH recidivante o refractario que hayan recibido al menos una terapia previa que incluyese el rituximab como uno de los tratamientos.
    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. Evaluar la duración de la respuesta.
    2. Determinar la seguridad y tolerabilidad de MOR00208.
    3.Evaluar la posible inmunogenicidad de MOR00208.
    4. Evaluar la farmacocinética y la farmacodinámica de MOR00208 en pacientes con LNH recidivante o refractario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients are male or female older or equal to 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 one prior rituximab-containing 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) greater or equal to 1.0 (1000/mm3)
    b. Platelet count greater or equal to 75 × 10E9/L without previous transfusion within 10 days of first study drug administration
    c. Haemoglobin greater or equal to 8.0 g/dL (may have been transfused)
    d. Serum creatinine < 2.0 x upper limit of normal (ULN)
    e. Total bilirubin lower or equal to 2.0 × ULN
    f. Alanine transaminase (ALT) and aspartate aminotransferase (AST) lower or equal to 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. Los pacientes podrán ser de cualquier sexo y deberán tener al menos 18 años.
    2. Los pacientes deberán presentar un diagnóstico histológicamente confirmado de alguno de los siguientes linfomas de células B, según la clasificación REAL/OMS:
    a. LF
    b. Otros tipos de LNH indolente (p.ej. LZM/ linfoma TLAM)
    c. LDCBG
    d. LCM
    3. El LNH de los pacientes debe haber progresado después de al menos una terapia previa que contuviese rituximab.
    4. Los pacientes deben presentar al menos una zona de enfermedad medible por resonancia magnética (RM) o tomografía computarizada (TC), definida como la presencia de al menos una lesión con dimensiones mínimas de 1,5 × 1,5 cm. Excepción: solo en el caso de pacientes con LCM, podrá incluirse a pacientes con enfermedad no medible pero ubicaciones evaluables (médula ósea, bazo, sangre periférica, tubo digestivo).
    5. En los pacientes que hayan recibido previamente un trasplante autólogo de células madre deberán haber transcurrido al menos 4 semanas de dicho trasplante antes de la administración del fármaco del estudio y deberá existir una recuperación hematológica completa.
    6. Al comenzar la administración del fármaco del estudio, los pacientes deberán llevar al menos 60 días sin recibir el tratamiento anterior con anticuerpos monoclonales (salvo el rituximab) ni recibir radioinmunoterapia.
    7. Los pacientes deberán llevar al menos 14 días sin recibir rituximab antes de la visita de cribado, y deberá existir confirmación de que no han respondido al tratamiento con rituximab o han experimentado una progresión de la enfermedad tras dicho tratamiento.
    8. Los pacientes con LDCBG deberán presentar en el momento inicial un resultado positivo de la tomografía de emisión de positrones con [18F]-fluorodesoxiglucosa (TEP-FDG) (criterios de respuesta de Cheson).
    9. Los pacientes deberán tener una esperanza de vida superior a 3 meses.
    10. Los pacientes deberán tener un índice de calidad de vida inferior a 3 en la escala ECOG.
    11. Los pacientes deberán cumplir los siguientes criterios de laboratorio en el momento del cribado:
    a. Recuento absoluto de neutrófilos (RAN) mayor o igual a 1,0 (1000/mm3)
    b. Recuento de plaquetas mayor o igual a 75 × 109/L sin transfusión previa en los 10 días anteriores a la primera administración del fármaco del estudio
    c. Hemoglobina mayor o igual a 8,0 g/dL (puede proceder de transfusión)
    d. Creatinina sérica < 2,0 × límite superior de la normalidad (LSN)
    e. Bilirrubina total menor o igual a 2,0 × LSN
    f. Alanina-transaminasa (ALT) y aspartato-aminotransferasa (AST) menor o igual a 2,5 × LSN.
    12. En el caso de mujeres potencialmente fértiles deberá confirmarse una prueba de embarazo negativa antes de la inclusión, y deberá utilizarse un método anticonceptivo de doble protección (anticonceptivo oral más anticonceptivo de barrera) durante el estudio y en los 3 meses siguientes a la última dosis; alternativamente deberá confirmarse que la paciente ha sido sometida a una histerectomía, ovariectomía o ligadura de trompas clínicamente documentadas.
    13. En el caso de los pacientes varones, deberán utilizar un método anticonceptivo de barrera eficaz durante el estudio y en los 3 meses siguientes a la última dosis cuando mantengan relaciones sexuales con una mujer potencialmente fértil.
    14. Los pacientes deberán ser capaces de cumplir todos los procedimientos, medicaciones y evaluaciones relacionados con el estudio.
    15. Los pacientes deberán ser capaces de comprender el consentimiento informado, dar dicho consentimiento por escrito y cumplir el protocolo del estudio.
    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, non-melanoma 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/or not cooperative.
    1. Tratamiento previo con quimioterapia citotóxica, inmunoterapia, radioterapia u otra terapia específica contra el linfoma en los 14 días anteriores a la visita de cribado, o paciente no recuperado de los efectos secundarios de una terapia previa específica contra el linfoma.
    2. Tratamiento con un agente sistémico en fase de investigación en los 28 días anteriores a la visita de cribado.
    3. Tratamiento previo con un anticuerpo anti-CD19 o sus fragmentos
    4. Trasplante alógeno previo de células madre.
    5. Sospecha o confirmación de hipersensibilidad a los excipientes contenidos en la formulación del fármaco del estudio.
    6. Enfermedad cardiovascular o insuficiencia cardiaca clínicamente significativas (clases III-IV de la clasificación NYHA), cardiomiopatía, preexistencia de arritmia clínicamente significativa, infarto agudo de miocardio en los 3 meses anteriores a la inclusión, angina de pecho en los 3 meses anteriores a la inclusión.
    7. Signos clínicos o analíticos de hepatitis B activa (resultado positivo para el antígeno de superficie de la hepatitis B [HBsAg] con resultado negativo del anticuerpo de superficie de la hepatitis B [HBsAb]) o hepatitis C activa (resultado positivo del anticuerpo contra el virus de la hepatitis C [VHC] y ácido ribonucleico [ARN] del VHC detectable con concentración de ALT por encima del intervalo de normalidad).
    8. Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH).
    9. Cualquier infección sistémica activa (vírica, fúngica o bacteriana) que requiera antibioterapia parenteral en las 4 semanas anteriores a la administración del fármaco del estudio.
    10. Tratamiento en curso con inmunosupresores que no sean corticoesteroides con prescripción médica (los cuales no podrán superar el equivalente a 10 mg de prednisona).
    11. Intervenciones de cirugía mayor o radioterapia en las 4 semanas anteriores a la primera administración del fármaco del estudio.
    12. Enfermedades sistémicas (cardiovasculares, renales, hepáticas, etc.) que en opinión del investigador impidan el tratamiento del estudio.
    13. Antecedentes o signos clínicos de enfermedades del sistema nervioso central (SNC), enfermedad meníngea o enfermedad epidural, incluidas metástasis cerebrales.
    14. Tratamiento/quimioterapia activos para otro tumor maligno primario en los 5 años anteriores (salvo en los casos de carcinoma intracanalicular de mama localizado, cáncer de piel no melanómico, cáncer de próstata que no requiera tratamiento y carcinoma cervical localizado).
    15. Mujeres embarazadas o lactantes, o mujeres potencialmente fértiles que no usen un método anticonceptivo aceptable.
    16. Antecedentes de incumplimiento terapéutico o pacientes considerados potencialmente no fiables y/o no cooperadores.
    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
    Tasa de respuesta global (TRG) (remisión completa [RC] + remisión parcial [RP]), evaluada según los criterios de respuesta del Grupo de Trabajo Internacional (IWG) de 2007
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. After 40 patients
    2. After 80 patients
    1. Tras la inclusión de 40 pacientes
    2. Tras la inclusión de 80 pacientes
    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 [?Z], 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 B,T- and 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 (Fc?R)IIIa and Fc?RIIa polymorphism
    1. Enfermedad estable (EE), duración de la respuesta (DR), tiempo hasta la progresión (THP) y supervivencia sin progresión (SSP)
    2. Incidencia y gravedad de los AA
    3. Número y proporción de pacientes que desarrollen en su caso anticuerpos anti MOR00208, así como evaluaciones semicuantitativas de dichos anticuerpos (determinación de la concentración de anticuerpos anti-MOR00208 en muestras positivas confirmadas)
    4. Farmacocinética (concentración sérica máxima aparente [Cmax], tiempo hasta la concentración sérica máxima [tmax], concentración sérica mínima aparente antes de la administración [Cpd], superficie bajo la curva temporal de concentración sérica desde el momento 0 hasta el momento t de la última concentración cuantificable [AUC0-t], superficie bajo la curva temporal de concentración sérica desde el momento 0 hasta el infinito (extrapolada) [AUC0-?], constante de velocidad terminal aparente [?Z], semivida terminal aparente [t½], eliminación corporal total [CL], volumen de distribución durante la fase terminal [Vz]); parámetros determinados mediante análisis de datos no compartimental)
    5. Variación absoluta y porcentual con respecto al momento inicial en las concentraciones de linfocitos B, T y NK
    6. Evaluación de los AA y de la TRG, estratificada en función de la expresión inicial de CD19 en las células malignas del linfoma.
    7. Evaluación de los AA y de la TRG, estratificada en función del polimorfismo (Fc?R)IIIa y Fc?RIIa
    E.5.2.1Timepoint(s) of evaluation of this end point
    After end of study
    A la finalización del ensayo
    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 No
    E.6.9Dose response No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    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
    Belgium
    Germany
    Hungary
    Italy
    Poland
    Spain
    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
    LPLV
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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
    No está previsto facilitar tratamiento posterior. Los médicos de los pacientes decidirán el mejor tratamiento a posteriori.
    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 Decision2013-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
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