Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-000834-50
    Sponsor's Protocol Code Number:MGN1703-C06
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-06-09
    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 number2014-000834-50
    A.3Full title of the trial
    IMPALA-Trial: Evaluation of an immunomodulatory maintenance treatment in patients with metastatic colorectal cancer with tumor reduction during induction treatment - A phase III trial
    Ensayo IMPALA:Evaluación de un tratamiento de mantenimiento inmunomodulador en pacientes con cáncer colorrectal metastásico con reducción del tumor durante el tratamiento de inducción. Un ensayo en fase III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to assess the effectiveness of treatment with MGN1703 in further delaying the time of first tumour progression in patients with metastatic colorectal cancer that have already experienced tumor reduction after receiving treatment with standard first-line chemotherapy.
    Un ensayo para evaluar la eficacia del tratamiento con MGN1703 para retrasar aún más el tiempo de progresión del primer tumor en pacientes con cáncer colorrectal metastásico que ya han experimentado reducción del tumor después de recibir tratamiento con quimioterapia estándar de primera línea
    A.3.2Name or abbreviated title of the trial where available
    IMPALA trial
    A.4.1Sponsor's protocol code numberMGN1703-C06
    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 SponsorMOLOGEN 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 supportMOLOGEN AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMOLOGEN AG
    B.5.2Functional name of contact pointDr. Andreas Dax
    B.5.3 Address:
    B.5.3.1Street AddressFabeckstr. 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14195
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930 84 17 8839
    B.5.5Fax number+493084 17 8850
    B.5.6E-maila.dax@mologen.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 nameMGN1703
    D.3.2Product code MGN1703
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdSLIM-30L1
    D.3.9.2Current sponsor codeMGN1703
    D.3.9.3Other descriptive nameA synthetic DNA-based double Stem Loop Immunomodulator 30L1
    D.3.9.4EV Substance CodeSUB32567
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic colorectal cancer
    Cáncer colorrectal metastásico
    E.1.1.1Medical condition in easily understood language
    Cancer of the colon that has spread to another part of the body.
    Cáncer de colon que se ha extendido a otra parte del cuerpo.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10010036
    E.1.2Term Colorectal carcinoma
    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
    The primary objective of the IMPALA trial is the evaluation of the efficacy of a novel maintenance treatment with MGN1703 to increase overall survival (OS) in patients with metastatic colorectal cancer with tumor reduction after induction treatment with standard first-line chemotherapy, with or without biological agents.
    El objetivo principal del ensayo IMPALA es la evaluación de la eficacia de un tratamiento de mantenimiento novedoso con MGN1703 para mejorar la supervivencia global (SG) en pacientes con cáncer colorrectal metastásico con reducción del tumor después del tratamiento de inducción con quimioterapia de primera línea convencional, con o sin fármacos biológicos
    E.2.2Secondary objectives of the trial
    The secondary objectives are efficacy parameters such as progression free survival and survival endpoints, toxicity and safety, tolerability, Quality of Life and patient related outcome (in participating study sites), and translational research.
    Los objetivos secundarios son los parámetros de eficacia, tales como Los criterios de valoración de supervivencia libre de progresión y supervivencia global, toxicidad y seguridad, tolerabilidad, calidad de vida y los resultados percibidos por el paciente (en los centros de estudio participantes) y la Investigación traslacional
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent
    2. Male or female patient 18 years or older
    3. Histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage IV (UICC) disease (primary tumor may be present)
    4. Complete or partial response, as assessed by local investigators according to RECIST 1.1, after 12-30 weeks of induction treatment with standard first-line chemotherapy with or without biological agents
    5. ECOG PS 0-1
    6. Haematology and biochemistry laboratory results within the limits normally expected for the patient population:
    - Absolute neutrophil count >= 1.0x10 9/L
    - Platelet count >= 100x10 9/L
    - Leukocyte count >= 3.0x10 9/L
    - Lymphocytes >= 1.0x10 9/L
    - Haemoglobin >= 9.0 g/dL or 5.59 mmol/L
    - Total bilirubin <=2 times the upper limit of normal (ULN)
    - AST <=3xULN in absence of liver metastases, or <=5.0xULN in presence of liver metastases
    - ALT <=3xULN in absence of liver metastases, or <=5.0xULN in presence of liver metastases
    - Serum creatinine <=1.5xULN

    7. Male and female patients of childbearing potential (i.e. not post-menopausal for at least 24 consecutive months and did not undergo surgical sterilization: hysterectomy, bilateral tubal ligation, or bilateral oophorectomy for women, vasectomy for men) using an effective means of contraception with a failure rate of less than 1% per year, e.g. established use of oral, implanted or injected hormonal contraceptives; placement of intra-uterine device (IUD) or intra-uterine system (IUS); use of barrier methods such as condom or diaphragm together with spermicide product; true abstinence (when it is in line with preferred and usual lifestyle of the patient). Females of child bearing potential must have a negative serum pregnancy test.
    1. Consentimiento informado por escrito firmado
    2. Paciente de sexo masculino o femenino de 18 años o más
    3. Diagnóstico de cáncer colorrectal confirmado histológicamente con enfermedad irresecable en estadio IV (UICC) (el tumor primario puede estar presente)
    4. Remisión completa o parcial, evaluada por los investigadores locales según los criterios RECIST 1.1, después de 12-30 semanas de tratamiento de inducción con quimioterapia de primera línea convencional con o sin fármacos biológicos
    5. EF ECOG 0-1
    6. Resultados de análisis de hematología y bioquímica dentro de los límites previstos para la población de pacientes:
    - Cifra absoluta de neutrófilos >= 1,0 x 109/l
    - Cifra de trombocitos >= 100 x 109/l
    - Cifra de leucocitos >= 3,0 x 109/l
    - Cifra de linfocitos >= 1,0 x 109/l
    - Hemoglobina >= 9,0 g/dl o 5,59 mmol/l
    - Bilirrubina total <=2 veces el límite superior de la normalidad (LSN)
    - AST <=3 x LSN en ausencia de metástasis hepáticas o <=5,0 x LSN en presencia de metástasis hepáticas
    - ALT <=3 x LSN en ausencia de metástasis hepáticas o <=5,0 x LSN en presencia de metástasis hepáticas
    - Creatinina sérica <=1,5 x LSN
    7. Pacientes de sexo masculino y femenino en edad fértil (es decir, en estado no menopáusico durante al menos 24 meses consecutivos y sin esterilización quirúrgica: histerectomía, ligadura de trompas bilateral u ovariectomía bilateral para mujeres; vasectomía para hombres) que utilizan un método anticonceptivo eficaz con una tasa de ineficacia inferior al 1 % anual, p. ej. uso establecido de anticonceptivos hormonales orales, implantados o inyectados, colocación de un dispositivo intrauterino (DIU) o sistema intrauterino (SIU), uso de métodos de barrera, como preservativo o diafragma junto con un producto espermicida, abstinencia real (si coincide con el estilo de vida habitual del paciente). Las mujeres en edad fértil deben presentar un resultado negativo en la prueba de embarazo en sangre.
    E.4Principal exclusion criteria
    1. History of other malignant tumors within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
    2. Known brain metastases
    3. Contraindication to receiving MGN1703 as per current investigator's brochure
    4. Presence of acute bacterial infection or undiagnosed febrile condition
    5. Pre-existing autoimmune or antibody mediated diseases
    6. Chronic systemic immune therapy or immunosuppressant medication within the last 6 weeks; continuous steroid treatment within the last 2 weeks prior to randomization
    7. Use of antibiotic therapy within the last 2 weeks prior to randomization
    8. Inadequate pulmonary function according to the investigator?s judgment, history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
    9. HIV seropositivity or active HBV/HCV infection
    10. Serious concomitant disease or a medical condition that in the judgment of the investigator renders the patient at high risk of treatment complications
    11. Female patient who is pregnant or breast feeding
    12. Contraindication to receiving the planned standard maintenance treatment according to applicable SmPC
    13. Treatment with any investigational drug within 12 months prior to randomization
    14. Vaccination within 1 month prior to randomization
    15. Any medical, mental, psychological or psychiatric condition that in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
    1. Antecedentes de otros tumores malignos en los últimos 5 años, salvo carcinoma basocelular o carcinoma de cuello uterino in situ extirpado de forma curativa
    2. Metástasis cerebrales conocidas
    3. Contraindicación para recibir MGN1703 según lo previsto en el manual del investigador actual
    4. Presencia de infección bacteriana aguda o estado febril no diagnosticado
    5. Enfermedades autoinmunes o mediadas por anticuerpos preexistentes
    6. Inmunoterapia sistémica prolongada o medicación inmunosupresora en las 6 últimas semanas; tratamiento continuo con esteroides en las 2 semanas anteriores a la aleatorización;
    7. Uso de terapia con antibióticos en las 2 semanas anteriores a la aleatorización
    8. Actividad pulmonar inadecuada a criterio del investigador, antecedentes de enfermedad pulmonar intersticial, p. ej. neumonía o fibrosis pulmonar o evidencia de enfermedad pulmonar intersticial en la TC torácica inicial
    9. Seropositividad para el VIH o infección activa por el VHB/VHC
    10. Enfermedad concomitante grave o una afección médica que, a criterio del investigador, ponga al paciente en grave riesgo de sufrir complicaciones a raíz del tratamiento
    11. Paciente de sexo femenino en período de gestación o lactancia
    12. Contraindicación para recibir el tratamiento de mantenimiento convencional según el RCP aplicable
    13. Tratamiento con un fármaco en fase de investigación en los 12 meses anteriores a la aleatorización
    14. Vacunación 1 mes antes de la aleatorización
    15. Cualquier enfermedad física, mental, psicológica o psiquiátrica que, en opinión del investigador, no permita que el paciente termine el estudio o entienda la información para el paciente
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is overall survival after randomization (OS), defined as the time between the date of randomization and the date of death from any cause.
    Supervivencia global después de la aleatorización (SG), definida como el tiempo entre la fecha de aleatorización y la fecha de muerte por cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary study endpoint is overall survival after randomization (OS), defined as the time between the date of randomization and the date of death from any cause. Measured by imaging (CT/MRI) at screening and throughout study according to local practice.
    Supervivencia global después de la aleatorización (SG), definida como el tiempo entre la fecha de aleatorización y la fecha de muerte por cualquier causa. Medida por imagen ((TC o RM) en selección y a lo largo del estudio con arreglo a la práctica local.
    E.5.2Secondary end point(s)
    1. Overall survival from start of induction therapy (OSi)
    2. Overall survival rates at 3, 4 and 5 years after Randomization
    3. Progression free survival on study treatment (PFS on study) after randomization until second disease progression (PD) according to RECIST 1.1 (includes PFS1 and PFS2, see below).
    4. Progression free survival after randomization until first PD, necessitating discontinuation of maintenance and re-introduction of all first-line chemotherapy agents (PFS1).
    5. PFS after re-introduction of initial induction therapy until PD (usually followed by the start of a second line treatment) (PFS2)
    6. Progression free survival after first-line treatment, including induction chemotherapy before randomization, maintenance treatment and reintroduction until subsequent PD (usually followed by the start of a second line treatment) (PFS3)
    7. PFS rates at 2, 3, 4 and 5 years after randomization
    8. Primary and secondary endpoints will also be analyzed by stratification criteria and by maintenance strategy.
    - Overall response rate (ORR = CR + PR) after randomization according to RECIST v1.1 . PFS will be assessed according to RECIST 1.1.
    9. Responses and PD will be confirmed by independent radiological review for exploratory purposes only (the primary assessment will be that of the local investigators)
    10. Adverse events (toxicity) according to NCI CTC AE v4.03
    11. Quality of Life (QoL) assessment (EORTC QLQ C30 + CR29 and additional tools used locally) in selected study sites
    12. Translational research
    a.) All randomized patients will participate in the immuno-monitoring plan.
    b.) The Study Steering Committee may also propose additional research projects for the sponsor's approval. Those selected for separate funding will be detailed in annex protocols submitted to local ethics committees for approval at participating institutions and will be conducted in consenting patients only.
    1. Supervivencia global desde el inicio de la terapia de inducción (SGi)
    2. Tasas de supervivencia global 3, 4 y 5 años después de la aleatorización
    3. Supervivencia libre de progresión durante el tratamiento del estudio (SLP durante el estudio) después de la aleatorización hasta la segunda progresión tumoral (PT) con arreglo a los criterios RECIST 1.1 (incluye SLP1 y SLP2, véase más abajo).
    4. Supervivencia libre de progresión después de la aleatorización hasta la primera PT que requiere la suspensión de la terapia de mantenimiento o la readministración de todos los fármacos quimioterapéuticos de primera línea (SLP1).
    5. Supervivencia libre de progresión después de la reanudación de la terapia de inducción inicial hasta la PT (normalmente seguida de instauración de un tratamiento de segunda línea) (SLP2)
    6. Supervivencia libre de progresión después del tratamiento de primera línea, incluida quimioterapia de inducción antes de la aleatorización, tratamiento de mantenimiento y reanudación hasta la PT posterior (normalmente seguido de instauración de un tratamiento de segunda línea) (SLP3)
    7. Tasas de SLP 2, 3, 4 y 5 años después de la aleatorización
    8. Los criterios de valoración principal y secundarios también se analizarán según los criterios de estratificación y la estrategia de mantenimiento
    Tasa de respuesta global (TRG= RC+ RP) después de la aleatorización según RECIST v1.1. PFS se evaluarán según RECIST 1.1.

    9. Tasa de respuesta global (TRG = RC + RP) después de la aleatorización con arreglo a los criterios RECIST v1.1
    La SLP se evaluará de acuerdo a los criterios RECIST 1.1. Las respuestas y la PT serán confirmadas mediante revisión radiológica independiente con fines exclusivamente exploratorios (la evaluación principal será la que realizan los investigadores locales)
    10. Acontecimientos adversos (toxicidad) con arreglo a los criterios NCI CTCAE v4.03
    11. Evaluaciones de la calidad de vida (CV) (EORTC QLQ C30+CR29 e instrumentos adicionales utilizados a escala local) en centros de estudio seleccionados
    12. Investigación traslacional
    a) Todos los pacientes aleatorizados participarán en el plan de inmunomonitorización.
    b) El Comité Directivo del estudio también podrá proponer proyectos de investigación adicionales para su aprobación por parte del promotor. Los proyectos seleccionados para recibir financiación independiente se detallarán en protocolos anexos presentados a los comités éticos de investigación clínica locales para su aprobación en las instituciones participantes y se llevarán a cabo únicamente en los pacientes que otorguen su consentimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. from start of induction;

    2. 3, 4 and 5 yrs after random.

    3. on treatment after random. to 2nd PD

    4. after random. to 1st PD

    5. after re-intro of induction therapy until PD

    6. after 1st line treat. incl. induction chemo before random, maint treat & reintroduction until PD

    7. PFS rates at 2, 3, 4 yrs after random. All PFS by imaging from Scr to EoT according to local practice

    8. subgroup analyses: performed at various timepoints

    9. imaging from Scr to EoT according to local practice

    10. ongoing through study

    11. Some sites: Scr, Treat phase/maint; Treat phase/ re-induction at various visits to EOT

    12. Bloods: Scr, Treat phase/maintenance;Treat phase/ re-induction at various visits to EOT
    1. desde inicio inducción

    2. 3, 4 y 5 años tras random

    3. durante tratamiento tras random hasta 2 PT

    4. tras random. hasta 1 PT

    5. reanudación de terapia de inducción inicial hasta PT

    6. tras tratamiento primera línea. incl. quimioterapia de inducción antes de aleatorización, tto mantenimiento y reanudación hasta PT

    7. Tasas de SLP 2, 3, 4 y 5 años tras random. Toda SLP por imagen desde Scr a fin tto según práctica local.

    8. analisis subgrupo analyses: en varios momentos

    9. Imagen desde Scr a fin tto segun practica local

    10. a lo largo del estudio

    11. Algunos centros: Scr, Fase tto/mantenimiento; fase tto/Re-inducción en varias vistas hasta fin Tto.

    12. Sangre: Scr, Fase tto/mantenimiento; fase tto/Re-inducción en varias vistas hasta fin Tto
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Quality of Life and Translational research
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    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 Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The primary analysis of the overall survival will be performed after a total of 365 events have been observed in total from both treatment arms. The study will be closed 36 months after the randomization of the last patient.
    El análisis primario de supervivencia global se realizará tras de un total de 365 eventos observados en total de ambos brazos de tratamiento. El estudio se cerrará 36 meses tras de la aleatorización 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 297
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 243
    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 state89
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 540
    F.4.2.2In the whole clinical trial 540
    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)
    None
    Ninguno.
    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 Decision2014-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon Apr 29 13:01:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA