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    Summary
    EudraCT Number:2017-003689-28
    Sponsor's Protocol Code Number:BrEPEM-LH-22017
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-26
    Trial 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 number2017-003689-28
    A.3Full title of the trial
    A Phase Ib/II Trial of Combined SGN-35 (BrentuximabVedotin) Therapy with cyclophosphamide, procarbazine, prednisone, etoposide and mitoxantrone (BrEPEM) for Older Patients with Untreated Hodgkin Lymphoma (HL)
    Ensayo clínico fases Ib/II en terapia combinada de SGN-35 (BrentuximabVedotin) con ciclofosfamida, procarbacina, prednisona y mitoxantrona (BrEPEM) en pacientes ancianos con Linfoma de Hodgkin (HL) no tratado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase Ib/II Trial of Combined SGN-35 (BrentuximabVedotin) Therapy with cyclophosphamide, procarbazine, prednisone, etoposide and mitoxantrone (BrEPEM) for Older Patients with Untreated Hodgkin Lymphoma (HL)
    Ensayo clínico fases Ib/II en terapia combinada de SGN-35 (BrentuximabVedotin) con ciclofosfamida, procarbacina, prednisona y mitoxantrona (BrEPEM) en pacientes ancianos con Linfoma de Hodgkin (HL) no tratado.
    A.4.1Sponsor's protocol code numberBrEPEM-LH-22017
    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 SponsorGELTAMO (Grupo Español de Linfomas y trasplante autólogo de médula osea)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMillennium Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGELTAMO (Grupo Español de Linfomas y trasplante autólogo de médula osea)
    B.5.2Functional name of contact pointSecretaria Cientifica de GELTAMO
    B.5.3 Address:
    B.5.3.1Street AddressFortuny, 51, local 5
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28010
    B.5.3.4CountrySpain
    B.5.4Telephone number00349131 9 57 80
    B.5.5Fax number003491319 57 80
    B.5.6E-mailensayosclinicos01@geltamo.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 Adcetris
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namebrentuximab vedotin
    D.3.4Pharmaceutical form Powder for concentrate 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 INNBRENTUXIMAB VEDOTIN
    D.3.9.1CAS number 914088-09-8
    D.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Older Patients with Untreated Hodgkin Lymphoma
    Pacientes ancianos con linfoma de Hodgkin no tratados
    E.1.1.1Medical condition in easily understood language
    Older Patients with Untreated Hodgkin Lymphoma
    Pacientes ancianos con linfoma de Hodgkin no tratados
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080208
    E.1.2Term Classical Hodgkin lymphoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase Ib
    •To identify the maximum tolerated dose (MTD) of Brentuximab Vedotin (BV) in combination with EPEM, by assessment of dose limiting toxicity (DLT) in a 28-day schedule.
    •To assess the toxicity of the combination of BV with EPEM.
    Phase II
    •To assess the efficacy of BV in combination with EPEM by assessment of complete response rate among older patients with HL at the end of scheduled treatment
    Fase Ib
    •Determinar la dosis máxima tolerada (MTD) de Brentuximab Vedotin (BV) en combinación con EPEM mediante la evaluación de la dosis límite tolerada en un programa de 28 días.
    •Evaluar la toxicidad de la combinación de BV con EPEM.
    Fase II
    •Evaluar al final del tratamiento programado la eficacia de la BV en combinación con EPEM mediante la evaluación de la tasa de respuesta completa en pacientes ancianos con LH
    E.2.2Secondary objectives of the trial
    •To evaluate (PFS), (EFS) and (OS) with this treatment regimen
    •To evaluate the duration of response with this treatment regimen
    •To evaluate the (ORR) based on best response (Complete Response [CR] and Partial Response [PR]) and the tumor local control rate (CR, PR, and stable disease [SD]) with this treatment regimen.
    •To assess the safety and tolerability of BV in combination with EPEM: type, frequency, and severity for adverse events (AEs) and relationship of AEs to this treatment regimen.
    •To assess the effects of therapy on the quality of life, the ability to perform everyday tasks and to determine how often side effects occur.
    •To evaluate the differential expression of CD30 between patients who achieved a sustained clinical response, and those who have will demonstrate refractory to therapy.
    •Proposal of Biomarkers for BV: by comparing protein expression and mutational patterns between responders and non-responders to therapy; targets will include:
    •Evaluar para esta combinación de tratamiento la (PFS), la (EFS) y la OS.
    •Evaluar la duración de respuesta de esta combinación de tratamiento.
    •Evaluar para esta combinación la (ORR) basada en la mejor respuesta posible (Respuesta Completa [CR] y Respuesta Parcial [PR]) y la tasa de control local del tumor (CR, PR y enfermedad estable [SD])
    •Evaluar la seguridad y tolerabilidad de BV en combinación con EPEM: tipo, frecuencia y severidad de los acontecimientos adversos y su relación con esta combinación.
    •Evaluar los efectos de la terapia en la calidad de vista, la capacidad para realizar las tareas diarias y determinar cada cuanto se producen reacciones adversas
    •Evaluar la expresión diferencial CD30 entre pacientes que alcanzan una respuesta clínica adecuada, y aquellos que demuestren resistencia al tratamiento
    •Proponer biomarcadoeres para BV: por comparación de patrones de expresión proteica y mutacional ente pacientes respondedores y no respondedores a la terapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Males or females of 60 years of age or older.
    2.Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified [NOS]).
    3.Stage IIB, III, and IV disease by Ann Arbor classification.
    4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
    5.Patients must have bi-dimensional measurable disease documented in the lymphoma baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm); patients with non-measurable disease in addition to measurable disease must have been assessed within 60 days prior to registration.
    6.Patients must have a bone marrow biopsy within 60 days prior to registration.
    7.Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60 days prior to study registration and the ejection fraction must be >= 50%.
    8.Adequate hematologic function, defined as Absolute neutrophil count (ANC) ≥ 1,500/mm3 / 1x109/L and Platelet count ≥75,000/mm3 / 75x109/L unless there is know marrow involvement of the disease
    9.Serum Creatinine < 2.0 mg/dl and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
    10.Total Bilirubin < 1.5 x the upper limit of normal (ULN) unless elevation is know to be due to Gilbert syndrome.
    11.ALT or AST must be < 3 x the upper limit of the normal range. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of hematologic/solid tumor in liver.
    12.Hemoglobin must be ≥ 8g/dL
    13.Patients must not have received prior chemotherapy or radiation therapy for the treatment of Hodgkin lymphoma.
    14.Female patient is either post-menopausal for at least 2 years before the screening visit or surgically sterile or if of childbearing potential must agree to use two effective contraceptive methods, at the same time, from the time of signing the informed consent and for 6 months following the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
    15.Male patients, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
    16.Patients must sign the informed consent form before registration. Voluntary written informed consent must be signed before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
    1.Hombre o mujer ≥ 60 años.

    2.Diagnóstico de Linfoma de Hodgkin clásico no tratados previamente (p.ej. esclerosis nodular, celularidad mixta, deplecion linfocitica, rico en linfocitos, y otros no especificados (NOS)).

    3. Enfermedad en estadio IIB, III o IV según la clasificación Ann Arbor.
    4.Punctuation ECOG de 0, 1 o 2.

    5.Pacientes con enfermedad bidimensional medible documentado en la evaluación tumoral basal del linfoma en los 30 días previos a la inclusión en el estudio (mínimo de 1.5 cm); además los pacientes con enfermedad no medible y enfermedad medible deberán tener una evaluación en los 60 días previos a la inclusión en el estudio.

    6.Pacientes con biopsia de medula ósea en los 60 días previos al registro en el estudio.

    7.Pacientes deben de tener una fracción de eyección >= 50%, evaluada con MUGA o ecocardiograma en los 60 días previos a la inclusión en el estudio.

    8.Función hematológica adecuada, definida como recuento absoluto de neutrófilos (ANC) ≥ 1,500/mm3 /1,5x109/L y recuento de plaquetas ≥ 75,000/mm3 / 75x109/L a menos que exista evidencia de infiltración medular por el linfoma. 

    9.Creatinina sérica < 2.0 mg/dl y/o aclaramiento de creatinina calculada > 40 mL/minutos.

    10.Bilirrubina total < 1.5 x LSN a menos que el aumento de bilirrubina se deba a un síndrome Gilbert [Gilbert-Meulengracht- Syndrome])

    11.ALT o AST < 3 x límite superior normal (LSN). AST y ALT podrían estar elevadas hasta 5 veces el LSN si esta elevación podría estar razonablemente atribuida a la presencia afectación hepática por el linfoma.

    12.Hemoglobina ≥ 8g/dL

    13.Pacientes que no hayan recibido previamente quimioterapia o radioterapia para el tratamiento del linfoma de Hodgkin.

    14. Mujeres en periodo postmenopáusico de 2 o más años de duración desde la visita de screeinig o mujeres quirúrgicamente estériles. Las mujeres en edad fértil deben aceptar el uso de dos métodos anticonceptivos eficaces al mismo tiempo, desde el momento de la firma del consentimiento informado y durante los 6 meses siguientes a la última dosis del medicamento del estudio, o aceptar acordar abstenerse completamente de relaciones heterosexuales.
    15. Los hombres tendrán que aceptar la anticoncepción de barrera efectiva durante todo el período de estudio y hasta 6 meses después de la última dosis del medicamento del estudio, incluso si están esterilizados quirúrgicamente (es decir, después de la vasectomía), o aceptar abstenerse por completo de las relaciones heterosexuales.
    16. Consentimiento informado firmado previo a la inclusión en el estudio.
    E.4Principal exclusion criteria
    1.Nodular lymphocyte predominant Hodgkin lymphoma
    2.Previous treatment with BV or any other prior anti-CD30-based antibody therapy
    3. Female patient who is both lactating and breast-feeding or has a positive pregnancy test during the screening period or a positive pregnancy test on Day 1 before the first dose of study drug
    4.History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: early stage [stage I or II] breast cancer treated with surgery and radiation +/- hormones [without adjuvant chemotherapy], non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou test [PAP smear])
    5.Known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of PML
    6.Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first dose
    7.Known or suspected hepatitis B infection, or known or suspected active hepatitis C infection
    Known human immunodeficiency virus (HIV) positive
    8.Patients with a known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
    9.Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent
    10.Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
    11.Any sensory or motor peripheral neuropathy greater than or equal to 2
    12.Known history of any of the following cardiovascular conditions;
    a. Myocardial infarction within 2 years of enrollment
    b. New York Heart Association (NYHA) Class III or IV heart failure
    c. Evidence of uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
    1. Linfoma de Hodgkin nodular con predominio de linfocitos.
    2.Tratamiento previo con Brentuximab vedotin o cualquier otra terapia previa basada en anti CD30

    3.Mujeres en periodo de lactancia o con test de embarazo positivo durante el periodo de screening o test de embarazo positivo el día 1 antes de la primera dosis del estudio.

    4.Cualquier otra neoplasia en los 3 últimos años (a excepción de cáncer de mama en estadio temprano (I o II) tratado con cirugía y radiación +/- hormonas (sin quimioterapia adyuvante), carcinoma cutáneo, extirpado complete del melanoma in situ [estadio 0], cáncer de próstata localizado tratado curativamente, y carcinoma cervical in situ con biopsia o lesión escamosa intraepitelial en la prueba de Papanicolaou.

    5.Enfermedad cerebral y/o meníngea conocida (HL o cualquier otra etiología), incluido signos o síntomas de leucoencefalopatía multifocal progresiva..
    6.Cualquier actividad viral sistémica, bacteriana, o infección fúngica que requiera tratamiento con terapia anti-microbiana en la semana previa a la administración de la primera dosis.

    7.Infección por Hepatitis B conocida o sospecha de infección de hepatitis B, o infección por hepatitis C active conocida o sospecha de infección de hepatitis C. VIH positivo conocido
    8.Pacientes con hipersensibilidad conocida a proteínas recombinantes, proteínas murinas, o cualquier otro excipiente contenido en la formulación de brentuximb vedotin

    9.Pacientes con demencia o el estado mental alterado que pudiera perjudicar el entendimiento e interpretación del consentimiento informado.
    10.Enfermedad neurológica sintomática que comprometa la normalidad de las actividades cotidianas o requiera medicación.

    11.Cualquier neuropatía periférica sensorial o motora mayor o igual a grado 2
    12.Historia conocida de cualquier de las siguientes condiciones cardíacas:
    a. Infarto de miocardio en los 2 años previos a la inclusión 

    b. NYHA Clase III o IV 

    c. Evidencia de condición cardiovascular no controlada, incluyendo arritmias, insuficiencia cardiaca congestiva o infarto de miocardio o anormalidades en el sistema de conducción.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    •Dose-limiting toxicity (DLT) of the combination treatment (BV + EPEM)
    •Maximum tolerated dose (MTD)of BV-EPEM for the phase II part of the study
    •(Severe) Adverse Events during the combination treatment
    Phase 2: Complete response (CR) rate after the 6 cycles of BV-EPEM therapy (based on the results of the PET scan).
    Fase 1:
    Toxicidad limitante de dosis del tratamiento combinado BV + EPEM
    Dosis máxima tolerada de BV-EPEM para la parte de fase II del estudio
    Eventos adversos (Graves) durante el tratamiento de combinación
    Fase II: tasa de CR después de 6 ciclos de terapia con BV-EPEM (basados en los resultados del PET)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1 part:
    The patients will be monitored closely for adverse events. The number of
    patients with unacceptable toxicities, requests to stop treatment or death will be determined at day 28 after
    start of each one of the 6 cycles , when 6 patients have been entered in a dose level.

    Phase 2 part: the endpoints will be evaluated when data for 6 BV-EPEM
    cycles are available for all patients
    Fase I:
    Se monitorizarán estrechamente los AEs. EL número de pacientes con toxicidad inaceptable, paradas de tratamiento requerido o muerte serán evaluados en el dia 28 de cada uno de los 6 ciclos, cuando 6 pacientes hayan entrado en uno de los niveles de dosis.
    Fase 2:
    La variable será evaluada cuando los datos de los 6 ciclos de EV-EPEM estén disponibles para todos lo pacientes
    E.5.2Secondary end point(s)
    •Progression free survival (PFS): defined as the time from the date of registration to the date of first documented tumor progression or death from any cause, whichever occurs first.
    •Event free survival (EFS): defined as the time from the date of registration until failure of treatment (either no CR or PR on treatment or relapse) or death as a result of any case.
    •Overall survival (OS): defined as the time from study entry to death from any cause. All deaths will be included, whether they occur on study or following treatment discontinuation. For patients who have not died, overall survival will be censored at the date of last contact.
    •Duration of response: defined as the time from first documentation of CR or PR to disease progression or death from any cause, whichever occurs first.
    • Overall response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD]).
    • Safety and tolerability as assessed by type, frequency, and severity for AEs and relationship of AEs to the combination of BV and EPEM chemotherapy.
    •Supervivencia libre de progresión: Definido como el tiempo transcurrido desde la inclusión del primer paciente en el estudio hasta la progresión de la enfermedad o muerte por cualquier causa, lo que ocurra antes
    •Supervivencia libre de acontecimientos. Definido como el tiempo transcurrido desde la inclusión en el ensayo hasta el fracaso terapéutico (tanto la no RC o la RP en tratamiento o recaída) o la muerte por cualquier causa.
    •Supervivencia global (SG): Definida como el tiempo transcurrido entre la entrada en el ensayo y la muerte por cualquier causa. Todos los casos de muerte serán incluidos tanto si ocurren durante el estudio como si ocurren tras la discontinuación del tratamiento. Los pacientes que no hayan fallecido, sus datos de SG se censurarán en la fecha del último contacto.
    •Duración de la respuesta. Definida como la fecha en que existe un indicio de RC o RP hasta la fecha de la progresión de la enfermedad o muerte por cualquier causa, lo que ocurra antes.
    •Tasa de respuesta global basada en la mejor respuesta (RC y RP) y tasa de control local del tumor ( RC, RP, y enfermedad estable ED)
    •Seguridad y tolerabilidad evaluadas por el tipo, frecuencia y gravedad de los AEs y relación de AEs con la combinación de quimioterapia de BV y EPEM
    E.5.2.1Timepoint(s) of evaluation of this end point
    These endpoints will be evaluated when the relevant data for all patients are available in the phase 1 and phase 2
    Estas variables serán evaluadas cuando los datos relevantes de todos los pacientes de la fase I y II estén disponibles
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose finding
    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 No
    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.8.3 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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of trial is defined as the last patient last visit.
    La finalización del estudio se define como la última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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)
    Patients will be treated according to the local standard care.
    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 Decision2018-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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