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    Summary
    EudraCT Number:2012-003253-28
    Sponsor's Protocol Code Number:MV130-SLG-001
    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:2012-10-29
    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 number2012-003253-28
    A.3Full title of the trial
    Randomized double-blind placebo-controlled prospective, parallel, multicentre clinical trial of bacterial polivalent vaccine (BACTEK ®)administered by sublingual mucosa in subjects with chronic obstructive pulmonary disease (COPD) for eficacy evaluation, security and immunomodulatory response.
    ENSAYO CLÍNICO PROSPECTIVO ALEATORIZADO, DOBLE CIEGO, PARALELO CONTROLADO FRENTE A PLACEBO DE UNA VACUNA BACTERIANA POLIVALENTE (BACTEK®) ADMINISTRADA POR VÍA MUCOSA SUBLINGUAL EN SUJETOS CON ENFERMEDAD PULMONAR OBSTRUCTIVA CRÓNCIA (EPOC) PARA LA EVALUACIÓN DE LA SEGURIDAD Y EFICACIA CLÍNICA Y DE LA RESPUESTA INMUNOMODULADORA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy and safety of Bactek in COPD
    Evaluación de la eficacia y seguridad de Bactek en EPOC
    A.4.1Sponsor's protocol code numberMV130-SLG-001
    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 SponsorInmunotek S.L.
    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 supportInmunotek S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInmunotek S.L.
    B.5.2Functional name of contact pointMiguel Casanovas; Medical Director
    B.5.3 Address:
    B.5.3.1Street AddressVelázquez, 124
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number34916510010
    B.5.5Fax number34916639732
    B.5.6E-mailmcasanovas@inmunotek.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 nameBactek
    D.3.2Product code MV130
    D.3.4Pharmaceutical form Sublingual spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    Sublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBactek
    D.3.9.1CAS number 8000045-24-1
    D.3.9.2Current sponsor codeMV130
    D.3.9.3Other descriptive nameALLERGENS, BACTERIA
    D.3.9.4EV Substance CodeSUB12782MIG
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000000
    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 placeboSublingual spray
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic obstructive pulmonary disease (COPD)
    Enfermedad pulmonar obstructiva crónica (EPOC)
    E.1.1.1Medical condition in easily understood language
    Chronic obstructive pulmonary disease (COPD)
    Enfermedad pulmonar obstructiva crónica (EPOC)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010953
    E.1.2Term COPD exacerbation
    E.1.2System Organ Class 100000004855
    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 eficacy of a bacterial vaccine administered sublingually, compared with placebo in subjects with moderate COPD based on the number of exacerbations of COPD
    Eevaluar la eficacia de una vacuna bacteriana administrada por vía sublingual, comparándola con placebo en sujetos con EPOC moderado basándonos en el número de exacerbaciones de EPOC
    E.2.2Secondary objectives of the trial
    - Severity of COPD exacerbations
    - Time from start of treatment until the first exacerbation of COPD.
    - Use of drugs (antibiotics, steroids, etc)
    - Number of doctor visits due to COPD exacerbations
    - Number of ER Visits: resulting in hospitalization or not resulting in hospitalization
    - Number of hospitalizations due to COPD exacerbations
    - Days of hospitalization due to COPD exacerbations
    - Quality of life related to health, as determined using an adapted version of:
    Questionnaires on quality of life: COPD Assessment Test (CAT)
    - Health costs during COPD exacerbations occurring during the trial period.
    -Changes in the immunological parameters
    - Safety Variables: adverse events, and evaluation of the local tolerability-reactions at the site of administration
    - Gravedad de las exacerbaciones de EPOC
    - Tiempo transcurrido desde el inicio del tratamiento hasta la primera exacerbación de EPOC.
    - Uso de fármacos (antibióticos, corticoides, etc)
    - Número de consultas médicas debidas a las exacerbaciones de EPOC
    - Número de Visitas a Urgencias: con resultado de hospitalización o sin resultado de hospitalización
    - Número de hospitalizaciones debidas a exacerbaciones de EPOC
    - Días de hospitalización por exacerbaciones de EPOC
    - Calidad de vida relacionada con la salud, determinada mediante una versión adaptada de: Cuestionarios específicos de calidad de vida: COPD Assesment Test (CAT)
    - Gasto sanitario derivado del consumo de recursos durante los episodios de exacerbación EPOC que ocurran durante el período del ensayo.
    - Variación de parámetros inmunológicos
    - Variables de seguridad:Acontecimientos adversos y evaluación de la tolerabilidad local, reacciones en el lugar de la administración
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Written informed consent.
    ? Both gender
    ? Age between 35 and 85.
    ? Must be able to follow the treatment regimen
    ? Diagnosis of moderate COPD according to GOLD criteria:
    Post-bronchodilator FEV1/FVC <70%,
    Post-bronchodilator FEV1 <80% predicted, with or without chronic symptoms (eg, cough, sputum production).
    ? Consumption of 10 or more packs of cigarettes / year. The subject may or may not be active smokers.
    ? The subject included in this clinical trial must live in the Community of Madrid from September to May during the clinical trial period
    ? The subject included in the clinical trial must have been vaccinated with pneumococcal polysaccharide vaccine at least 4 weeks before administration of Bactek ®
    ? To increase the population of subjects that are more prone to have acute exacerbations each individual must meet one or more of the following four conditions:
    - Use or have used supplementary O2 (except O2 home use)
    - Have received systemic corticosteroids for respiratory problems in the last year
    - Having gone to the emergency room, at least one exacerbation of COPD in the last year
    - Have been hospitalized due to exacerbation of COPD in the last year
    ? Fertile women of must use an approved contraceptive method (oral, vaginal, transdermal, etc. IUDs or barrier methods) and get a negative pregnancy test in urine made during the selection.
    - Haber otorgado el consentimiento informado por escrito.
    - Ambos sexos
    - Edad comprendida entre 35 y 85 años.
    - Deben ser capaces de cumplir el régimen de dosificación
    - Diagnóstico de EPOC moderada según los criterios definidos en el GOLD
    - Post-broncodilatador FEV1/FVC <70%,
    - Post-broncodilatador FEV1 <80% predicho, con o sin síntomas crónicos (ej., tos, producción de esputo).
    - Consumo de 10 o más paquetes de cigarrillos / año. El sujeto pueden ser o no fumador activo.
    - Los sujeto incluido en el ensayo deberán residir en la Comunidad de Madrid en los meses septiembre-mayo durante el período del ensayo
    - Los sujeto incluidos en el ensayo deberá haber sido vacunados con la vacuna antineumococica polisacárida al menos 4 semanas antes del inicio de la administración de Bactek®
    - Para aumentar la población de sujetos que son más propensos a tener exacerbaciones agudas (144)cada sujeto debe cumplir con una o más de las siguientes cuatro condiciones:
    ? Utilizar o haber utilizado O2 suplementario (excepto O2 domiciliario continuo)
    ? Haber recibido corticosteroides sistémicos para los problemas respiratorios en el último año
    ? Haber acudido a urgencias por, al menos, una exacerbación de EPOC en el último año
    ? Haber estado hospitalizado por una exacerbación de EPOC en el último año
    ? Las mujeres en edad fértil deberán utilizar un método anticonceptivo aprobado (anticonceptivos orales, vaginales, transdérmicos, DIU etc o los métodos de barrera) y obtener un resultado negativo en la prueba de embarazo en orina realizada durante la selección.
    E.4Principal exclusion criteria
    ? Subject outside of age range
    ? Subject unable to offer cooperation and / or have severe psychiatric disorders
    ? Pregnant women, breastfeeding or wishing to become pregnant during the study (including assisted reproductive processes), or to reject the use of contraception during the study (including barrier). Women who become pregnant will have to discontinue their participation in this clinical trial.
    ? Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion
    ? Subject diagnosed with asthma according to American Thoracic Society and European Respiratory Society.guidelines
    ? The presence of another diagnosis other than COPD that makes the subject unstable or has a life expectancy <3 years
    ? Subject who has had an exacerbation 4 weeks before starting the trial.
    ? Subject that have needed inhaled corticosteroids in the last 4 weeks before starting the trial
    ? Subject who has received systemic corticosteroids (vo, im, iv) in the last 4 weeks.
    ? Subject diagnosed with Primary or Secondary Immunodeficiency (ESID criteria) 12 months prior to inclusion in the trial
    ? Subjects with chronic lymphoproliferative disease
    ? Subjects with chronic infectious disease (TB, HCV, HIV, HBV)

    ? Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
    ? Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa
    ? Subject with COPD and bronchiectasis diagnosed by CT image before age 40
    ? Subject with severe COPD
    ?
    ? Subject requiring home O2 or Noninvasive Mechanical Ventilation
    ? Subject with a history of hypersensitivity to any component of the vaccine
    ? Subject outside of age range
    ? Subject unable to offer cooperation and / or have severe psychiatric disorders
    ? Pregnant women, breastfeeding or wishing to become pregnant during the study (including assisted reproductive processes), or to reject the use of contraception during the study (including barrier). Women who become pregnant will have to discontinue their participation in this clinical trial.
    ? Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion
    ? Subject diagnosed with asthma according to American Thoracic Society and European Respiratory Society.guidelines
    ? The presence of another diagnosis other than COPD that makes the subject unstable or has a life expectancy <3 years
    ? Subject who has had an exacerbation 4 weeks before starting the trial.
    ? Subject that have needed inhaled corticosteroids in the last 4 weeks before starting the trial
    ? Subject who has received systemic corticosteroids (vo, im, iv) in the last 4 weeks.
    ? Subject diagnosed with Primary or Secondary Immunodeficiency (ESID criteria) 12 months prior to inclusion in the trial
    ? Subjects with chronic lymphoproliferative disease
    ? Subjects with chronic infectious disease (TB, HCV, HIV, HBV)

    ? Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
    ? Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa
    ? Subject with COPD and bronchiectasis diagnosed by CT image before age 40
    ? Subject with severe COPD
    ?
    ? Subject requiring home O2 or Noninvasive Mechanical Ventilation
    ? Subject with a history of hypersensitivity to any component of the vaccine
    ? Sujeto que se encuentren fuera del rango de edad
    ? Sujeto que no puedan ofrecer cooperación y/o tengan trastornos psiquiátricos severos
    ? Mujeres embarazadas, en fase de lactancia o que prevean quedarse embarazadas a lo largo del estudio (inclusive procesos de Reproducción Asistida), o que rechacen la utilización de métodos contraceptivos durante el estudio (incluidos los de barrera). Las mujeres que se queden embarazadas tendrán que discontinuar su participación en este ensayo clínico.
    ? Sujeto que haya participado en un estudio o ensayo clínico con un producto en investigación durante los 3 meses anteriores a la inclusión.
    ? Sujeto diagnosticado de asma según las guías de la Sociedad Torácica Americana y la Sociedad Europea de Enfermedades respiratorias. Si después de aplicar los criterios especificados en las siguiente tabla, los investigadores aún pueden diferenciar entre EPOC y asma, se debe realizar una prueba de broncodilatación con salbutamol inhalado y se excluirán sujetos con cambios en el FEV1>400 ml
    ? La presencia de otro diagnóstico diferente del de EPOC que haga que el sujeto sea inestable o tenga una esperanza de vida < 3 años
    ? Sujeto que haya tenido una exacerbación en un tiempo inferior a las 4 semanas del inicio del ensayo.
    ? Sujeto que haya necesitado corticosteroides inhalados en las últimas 4 semanas
    ? Sujeto que haya recibido corticosteroides sistémicos (vo, im, iv) en las últimas 4 semanas.
    ? Sujeto diagnosticado de Inmunodeficiencia Primaria (Criterios ESID) o Secundaria 12 meses previos a la inclusión en el ensayo o en la visita basal del ensayo.
    ? Sujetos diagnosticado de enfermedad linfoproliferativa crónica
    ? Sujetos diagnosticado de enfermedad infecciosa crónica (TBC, VHC, VIH, VHB)
    ? Sujeto con cardiopatía crónica, arritmias o episodios de arritmia secundarios a la administración de broncodilatadores.
    ? Sujeto con diagnóstico de EPOC y colonización crónica por Pseudomonas aeruginosa
    ? Sujeto con EPOC y bronquiectasias diagnosticadas por imagen TAC antes de los 40 años
    ? Sujeto diagnosticado de EPOC grave
    ? Sujeto con necesidad de O2 domiciliario o Ventilación Mecánica No Invasiva
    ? Sujeto con historia de hipersensibilidad a alguno de los componentes de la vacuna
    ? Sujeto en tratamiento inmunosupresor con: Azatioprina, Metotrexate, Ciclosporina, Ciclofosfamida, Tacrolimus, Anti-malaricos, Sales de oro
    ? Sujeto que hayan recibido tratamiento con anticuerpos monoclonales tipo Rituximab o antiTNFalpha en los últimos 6 meses.
    ? Sujeto en tratamiento crónico con Azitromicina o antibióticos inhalados (tobramicina, colistina
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the eficacy of a bacterial vaccine administered sublingually, compared with placebo in subjects with moderate COPD based on the number of exacerbations of COPD
    Eevaluar la eficacia de una vacuna bacteriana administrada por vía sublingual, comparándola con placebo en sujetos con EPOC moderado basándonos en el número de exacerbaciones de EPOC
    E.5.1.1Timepoint(s) of evaluation of this end point
    The baseline and the end of the study
    Principio y el final del ensayo
    E.5.2Secondary end point(s)
    - Severity of COPD exacerbations
    - Time from start of treatment until the first exacerbation of COPD.
    - Use of drugs (antibiotics, steroids, etc)
    - Number of doctor visits due to COPD exacerbations
    - Number of ER Visits: resulting in hospitalization or not resulting in hospitalization
    - Number of hospitalizations due to COPD exacerbations
    - Days of hospitalization due to COPD exacerbations
    - Quality of life related to health, as determined using an adapted version of:
    Questionnaires on quality of life: COPD Assessment Test (CAT)
    - Health costs during COPD exacerbations occurring during the trial period.
    -Changes in the immunological parameters
    - Safety Variables: adverse events, and evaluation of the local tolerability-reactions at the site of administration
    -Gravedad de las exacerbaciones de EPOC
    - Tiempo transcurrido desde el inicio del tratamiento hasta la primera exacerbación de EPOC
    - Uso de fármacos (antibióticos, corticoides, etc)
    - Número de consultas médicas debidas a las exacerbaciones de EPOC
    - Número de Visitas a Urgencias: con resultado de hospitalización o sin resultado de hospitalización
    - Número de hospitalizaciones debidas a exacerbaciones de EPOC
    - Días de hospitalización por exacerbaciones de EPOC
    - Calidad de vida relacionada con la salud, determinada mediante una versión adaptada de: Cuestionarios específicos de calidad de vida: COPD Assesment Test (CAT)
    - Gasto sanitario derivado del consumo de recursos durante los episodios de exacerbación EPOC que ocurran durante el período del ensayo.
    - Variación de parámetros inmunológicos
    - Variables de seguridad:Acontecimientos adversos y evaluación de la tolerabilidad local, reacciones en el lugar de la administración
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Baseline
    - Visit 1 (first IMP intake)
    - Visit 2 (3 months after visit 1)
    - Visit 3 (6 months after visit 1)
    - Visit 4 (12 months after visit 1)
    -Visit 5 (18 months after visit 1)
    - Visita basal
    - Visita 1 (primera toma del medicamento en investigación)
    - Visita 2 (3 meses después de la visita 1)
    - Visita 3 (6 meses después de la visita 1)
    - Visita 4 (12 meses después de la visita 1)
    -Visita 5 (18 meses después de la visita 1)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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) 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 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 concerned3
    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
    Last patient last visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state180
    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
    No
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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