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    Summary
    EudraCT Number:2016-002944-18
    Sponsor's Protocol Code Number:BIA-HDMP-201
    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:2016-08-08
    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 number2016-002944-18
    A.3Full title of the trial
    MULTICENTRE, RANDOMIZED, DOUBLE BLIND CLINICAL TRIAL PHASE II, WITH SUBCUTANEOUS POLYMERIZED DEPOT IMMUNOTHERAPY AT DIFFERENT DOSES IN PARALLEL PLACEBO-CONTROLLED GROUPS IN PATIENTS WITH ALLERGIC RHINOCONJUNCTIVITIS, SENSITIZED TO HOUSE DUST MITES
    Ensayo Clínico Multicéntrico, aleatorizado, doble ciego, de fase II, con inmunoterapia polimerizado depot subcutaneo en dosis en diferentes grupos, controlado con placebo, paralelo, en pacientes con rinoconjuntivitis alérgica, sensibilizados a los ácaros del polvo doméstico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial with subcutaneous polymerized depot innmunotherapy in patients with allergic rhinoconjunctivitis, sensitized to house dust mites.
    Ensayo clínico con inmunoterapia polimerizado depot subcutaneo en pacientes con rinoconjuntivitis alérgica, sensibilizados a los ácaros del polvo doméstico.
    A.4.1Sponsor's protocol code numberBIA-HDMP-201
    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 SponsorBial Industrial Farmacéutica S.A.
    B.1.3.4CountrySpain
    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 supportBial Industrial Farmacéutica S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBial Industrial Farmacéutica S.A.
    B.5.2Functional name of contact pointMª Cruz Gómez
    B.5.3 Address:
    B.5.3.1Street AddressParque Científico y Tecnológico de Bizkaia. Edif. 401
    B.5.3.2Town/ cityZamudio (Vizcaya)
    B.5.3.3Post code48170
    B.5.3.4CountrySpain
    B.5.4Telephone number+3494 443 80 00
    B.5.5Fax number+3494 443 80 16
    B.5.6E-mailMcruz.gomez@bial.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 name1-day polymerized depot Allergovac
    D.3.2Product code V01AA
    D.3.4Pharmaceutical form Suspension 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 INNDERMATOPHAGOIDES PTERONYSSINUS
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES PTERONYSSINUS
    D.3.9.4EV Substance CodeSUB25740
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDERMATOPHAGOIDES FARINAE
    D.3.9.3Other descriptive nameDERMATOPHAGOIDES FARINAE
    D.3.9.4EV Substance CodeSUB29199
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The disease under study is allergic rhinoconjunctivitis secondary to sensitization to DPT and DF. Included in the study are patients diagnosed with that disease who also have associated mild asthma. The investigational drug is subcutaneous immunotherapy in polymerized depot presentation, containing a mixture of 50% DPT and DF extracts adsorbed onto 0.33% aluminium hydroxide.
    La enfermedad en estudio es la rinoconjuntivitis alérgica secundaria a la sensibilización a la DPT y DF. Incluidos en el estudio son pacientes diagnosticados con esta enfermedad, que también han asociado el asma leve. El fármaco en investigación es la inmunoterapia subcutánea en presentación depot polimerizado, que contiene una mezcla de 50% de DPT y extractos DF adsorbido en hidróxido de aluminio 0,33%.
    E.1.1.1Medical condition in easily understood language
    The disease under study is allergic rhinoconjunctivitis secondary to sensitization to DPT and DF, Included patients diagnosed with that disease who also have associated mild asthma.
    La enfermedad en estudio es la rinoconjuntivitis alérgica secundaria a la sensibilización a la DPT y DF, incluidos los pacientes con diagnóstico de esa enfermedad que también han asociado el asma leve
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical efficacy of immunotherapy by changing the concentration of the allergen (DPT- DF) required to produce a positive response in the nasal provocation test between the screening visit (V0) and the final visit (FV) of the study. Differences in this variation will be compared between the different treatment groups versus placebo.
    Evaluar la eficacia clínica de la inmunoterapia cambiando la concentración del alergeno (DPT- DF) requerida para producir una respuesta positiva en la prueba de provocación nasal entre la visita de selección (V0) y la visita final (FV) del estudio. Las diferencias en esta variación se compararon entre los diferentes grupos de tratamiento en comparación con placebo.
    E.2.2Secondary objectives of the trial
    To estimate the clinical efficacy of immunotherapy through the change in the mean symptom score after conducting the nasal provocation test between the V0 and FV.
    To evaluate the percentage of responder patients, without change patients and non-responder patients.
    To determinate the clinical efficacy of immunotherapy through the change in the average score in the scale visual analogic of rhinoconjunctivitis symptoms after receiving immunotherapy for six maintenance months, between the V0 and the FV.
    To establish the indirect efficacy of immunotherapy by measuring changes in levels of specific sIgE, total specific sIgG and specific sIgG4.
    To evaluate the indirect efficacy of immunotherapy through the reduction in the size of wheal by conducting the dose-response skin-prick test.
    To analyse the safety and tolerability of two doses of subcutaneous immunotherapy in polymerized depot.
    To analyze relevant variations in analytical results between visit 0 and the final visit.
    Estimar la eficacia clínica de la inmunoterapia a través del cambio en la puntuación media de los síntomas después de la prueba de provocación nasal.
    Evaluar el porcentaje de pacientes respondedores, sin cambios y los pacientes no respondedores.
    Determinar la eficacia clínica de la inmunoterapia a través del cambio en la puntuación media en la escala analógica visual de los síntomas de rinoconjuntivitis después de recibir la inmunoterapia durante seis meses de mantenimiento.
    Establecer la eficacia de la inmunoterapia indirecta mediante la medición de cambios en los niveles de sIgE específica, SigG específica total y sIgG4 específico.
    Evaluar la eficacia de la inmunoterapia indirecta a través de la reducción en el tamaño de la roncha mediante la realización de la prueba de punción cutánea dosis-respuesta. Enalizar la seguridad y la tolerabilidad de dos dosis de la inmunoterapia subcutánea en el depósito polimerizado.
    Analizar las variaciones relevantes en los resultados analíticos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who sign the informed consent sheet.
    2. Patients between 18 and 60 years of age.
    3. Patients with allergic rhinoconjunctivitis produced by their sensitivity to house dust mites: DPT and DF for at least one year before participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients with a mild concomitant asthmatic condition may also be included. Only patients with mild asthma can be admitted (Global Initiative for Asthma (GINA) 2015).
    4. Patients preferably sensitized to both DPT and DF with symptoms which are clinically relevant to the exposure and, in the opinion of the clinical investigator, for whom treatment with a vaccine of 50% DPT and DF in polymerized depot is indicated.
    5. Patients polysensitized to DPT and DF and also Lepidoglyphus destructor (LD), can be included, only in case, their level of specific IgE against at least one of the two dermatophagoides was at least double the level against LD.
    6. Patients who present a positive nasal provocation test to DPT/DF at least one of the three concentrations of DPT/DF, tested at the beginning of the study. The negative control of this test must produce a consistent result.
    7. Patients who have presented a skin-prick test result ≥3 mm in diameter for DPT and for DF. Both the negative and positive control of the test must produce consistent results.
    8. Patients with a specific IgE value ≥ class 2 (ImmunoCAP® System) for DPT and DF.
    9. Women of childbearing age must present a negative urine pregnancy test at entry to the study (V0) and before administration of the first vaccine dose.
    10. Also, the women at childbearing age (menarche), and the men participating in the study must agree to use a highly effective contraceptive method, according to (Clinical Trial Facilitation Group (CTFG) 2014), methods that can achieve a failure rate of less than 1% per year when used consistently and correctly.
    1. Los pacientes que firmar la hoja de consentimiento informado.
    2. Los pacientes entre 18 y 60 años de edad.
    3. Los pacientes con rinoconjuntivitis alérgica producida por su sensibilidad a los ácaros del polvo doméstico: DPT y DF durante al menos un año antes de participar en el estudio. Aunque la patología que se está estudiando es la rinoconjuntivitis alérgica, los pacientes con una condición asmática concomitante leve también pueden ser incluidos. Sólo los pacientes con asma leve pueden ser admitidos (Iniciativa Global para el Asma (GINA) 2015).
    4. Los pacientes sensibilizados con preferencia a ambos DPT y DF con síntomas que son clínicamente relevantes para la exposición y, en opinión del investigador clínico, para los que está indicado el tratamiento con una vacuna DPT del 50% y DF en el depósito del polimerizado.
    5. Los pacientes polisensibilizados de DPT y DF y también Lepidoglyphus destructor (LD), se pueden incluir, sólo en el caso, su nivel de IgE específica frente a al menos una de las dos dermatofagoides era al menos el doble del nivel contra el DL.
    6. Los pacientes que presentan una prueba de provocación nasal positiva a DPT / DF al menos una de las tres concentraciones de DPT / DF, probadas al inicio del estudio. El control negativo de esta prueba debe producir un resultado coherente.
    7. Los pacientes que han presentado un resultado de la prueba de punción cutánea ≥ 3 mm de diámetro para la DPT y DF. Tanto el control negativo y positivo de la prueba debe producir resultados consistentes.
    8. Los pacientes con una clase específica de IgE valor ≥ 2 (Sistema ImmunoCAP®) para la DPT y DF.
    9. Las mujeres en edad fértil deben presentar una prueba de embarazo en orina negativa al ingreso al estudio (V0) y antes de la administración de la primera dosis de la vacuna.
    10. Además, las mujeres en edad fértil (menarquia), y los hombres que participan en el estudio deben ponerse de acuerdo para utilizar un método anticonceptivo muy eficaz, de acuerdo con (Clinical Trial facilitación de grupos (CTFG) 2014), métodos que pueden lograr una tasa de fracaso de menos de 1% por año, cuando se usan sistemática y correctamente.
    E.4Principal exclusion criteria
    1. Patients who have received prior immunotherapy in the preceding 5 years for any of the tested allergens or a cross-reactive allergen, or are currently receiving any allergen immunotherapy.
    2. Patients with concomitant asthma who present a maximum expiratory volume in the first second of forced exhalation (FEV1) <70% of the predicted level at the time of inclusion, despite being controlled pharmacologically.
    3. Polysensitized patients to other airborne allergens apart from Dermatophagoides pteronyssinus and Dermatophagoides farinae, who upon inclusion may present clinical symptoms which are relevant in the view of the investigator, and at the time of the nasal provocation test at the end of the trial.
    4. Patients with immune, heart, kidney or liver diseases.
    5. Patients with a history of anaphylaxis.
    6. Patients with active chronic urticaria.
    7. Patients with active severe atopic eczema.
    8. Patients who participated in another clinical trial three months earlier.
    9. Pregnant women or breastfeeding mothers.
    10. Patients being treated with tricyclic antidepressants, phenothiazines, β-blockers, and angiotensin converting enzyme inhibitors (ACE inhibitors).
    11. Patients who cannot attend visits or, in the investigator's opinion, are unlikely to meet the study requirements.
    12. Lack of collaboration or refusal to participate by the patient, or of another type deemed by the investigator to be of sufficient importance to interference with the study.
    1. Los pacientes que han recibido inmunoterapia antes de los 5 años anteriores para cualquiera de los alérgenos probados o un alergeno de reactividad cruzada, o que actualmente están recibiendo cualquier inmunoterapia con alergenos.
    2. Los pacientes con asma concomitante que presentan un volumen espiratorio máximo en el primer segundo de la espiración forzada (FEV1) <70% del nivel previsto en el momento de la inclusión, a pesar de ser controlada farmacológicamente.
    3. Los pacientes polisensibilizados a otros alérgenos en el aire, aparte de Dermatophagoides pteronyssinus y Dermatophagoides farinae, que en la inclusión pueden presentar síntomas clínicos que son relevantes en la vista del investigador, y en el momento de la prueba de provocación nasal al final del ensayo.
    4. Pacientes con inmune, corazón, riñón o enfermedades del hígado.
    5. Los pacientes con antecedentes de anafilaxia.
    6. Los pacientes con urticaria crónica activa.
    7. Los pacientes con eczema atópico severo activa.
    8. Los pacientes que participaron en otro ensayo clínico tres meses antes.
    9. Las mujeres embarazadas o madres lactantes.
    10. Los pacientes tratados con antidepresivos tricíclicos, fenotiazinas, beta-bloqueantes, y inhibidores de la enzima convertidora de la angiotensina (IECA).
    11. Los pacientes que no pueden asistir a las visitas o, en opinión del investigador, es poco probable que cumplir con los requisitos del estudio.
    12. La falta de colaboración o negativa a participar por el paciente, o de otro tipo, a juicio del investigador como de suficiente importancia a la interferencia con el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the change in the concentration of the allergen (DPT- DF) required to produce a positive response in the nasal provocation test between the screening visit (V0) and the final visit (FV) of the study. Differences in this variation between the different treatment groups will be compared and with the placebo group too.
    El criterio de valoración primario del estudio es el cambio en la concentración del alergeno (DPT- DF) requerida para producir una respuesta positiva en la prueba de provocación nasal entre la visita de selección (V0) y la visita final (FV) del estudio. Las diferencias en esta variación entre los diferentes grupos de tratamiento serán comparados y con el grupo placebo también.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 weeks (25+3)
    28 semanas (25+3)
    E.5.2Secondary end point(s)
    • The change in the mean symptom score after conducting the nasal provocation test between the baseline visit (V0) and the final visit (FV) of the study. This variation in the symptom score will be compared between different treatment groups and against the placebo group.
    • The percentage of responder patients, without change patients and non-responder patients. The firsts are whose after receiving immunotherapy for six maintenance months, presents an increase in the concentration of the allergen (DPT-DF) required to produce a positive response in the nasal provocation test between the selection visit (V0) and the final visit (FV), in each group. The latter are whose after receiving immunotherapy for six maintenance months, presents a decrease in the concentration of the allergen (DPT-DF) required to produce a positive response in the nasal provocation test between the selection visit (V0) and the final visit (FV) in each group.
    • The change in the average score in the scale visual analogic, (EVA) of rhinoconjunctivitis symptoms after receiving immunotherapy for six maintenance months, between the baseline visit (V0) and the final visit (FV).
    • Difference obtained in immunoglobulin levels: specific IgE, total IgG and specific IgG4 between V0 and VF.
    • Comparison of the differences obtained in the wheal size between V0 and the intragroup VF.
    • Number and percentage of adverse reactions by number of patients and doses received; recorded by both the patient and the medical staff responsible for providing the subcutaneous immunotherapy.
    • In addition, variations in analytical results estimated to be clinically relevant, at the discretion of each principal investigator, will be analysed and compared between visit 0 and the final visit.
    • El cambio en la puntuación media de los síntomas después de la realización de la prueba de provocación nasal entre la visita basal (V0) y la visita final (FV) del estudio. Esta variación en la puntuación de los síntomas se comparó entre los diferentes grupos de tratamiento y contra el grupo placebo.
    • El porcentaje de pacientes respondedores, sin cambio los pacientes y los pacientes no respondedores. Los primeros son cuyo después de recibir la inmunoterapia durante seis meses de mantenimiento, presenta un aumento en la concentración del alergeno (DPT-DF) requerida para producir una respuesta positiva en la prueba de provocación nasal entre la visita de selección (V0) y la visita final (FV ), en cada grupo. Estos últimos son cuyo después de recibir la inmunoterapia durante seis meses de mantenimiento, se presenta una disminución en la concentración del alergeno (DPT-DF) requerida para producir una respuesta positiva en la prueba de provocación nasal entre la visita de selección (V0) y la visita final (FV ) en cada grupo.
    • El cambio en la puntuación media en la escala visual analógica (EVA) de síntomas de rinoconjuntivitis después de recibir la inmunoterapia durante seis meses de mantenimiento, entre la visita basal (V0) y la visita final (FV).
    • La diferencia obtenida en los niveles de inmunoglobulinas: IgE específica, el total de IgG e IgG4 específica entre V0 y VF.
    • Comparación de las diferencias obtenidas en el tamaño del habón entre V0 y la intragrupo VF.
    • Número y porcentaje de reacciones adversas por parte de los pacientes y número de dosis recibidas; registrado por el paciente y el personal médico responsable de proporcionar la inmunoterapia subcutánea.
    • Además, las variaciones en los resultados analíticos se prevé que estén clínicamente relevante, según el criterio de cada investigador principal, serán analizados y comparados entre 0 y visita de la visita final.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 weeks (25+3)
    28 semanas (25+3)
    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) 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    LVLS
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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: 100
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Clinical Practice
    Práctica clínica habitual
    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 Decision2016-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-04-10
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