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    Summary
    EudraCT Number:2017-001225-41
    Sponsor's Protocol Code Number:M14-430
    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:2018-05-10
    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 number2017-001225-41
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433
    Estudio multicéntrico aleatorizado, doble ciego y controlado con placebo de mantenimiento y de extensión a largo plazo, para evaluar la eficacia y la seguridad de upadacitinib (ABT-494) en sujetos con enfermedad de Crohn que han finalizado los estudios M14-431 o M14-433
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433
    Estudio de mantenimiento y extensión a largo plazo, de la eficacia y seguridad de Upadacitinib (ABT-494) en sujetos con enfermedad de Crohn que completaron los estudios M14-431 o M14-433
    A.4.1Sponsor's protocol code numberM14-430
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34901 20 01 03
    B.5.6E-mailabbvie_reec@abbvie.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 nameUpadacitinib
    D.3.2Product code ABT-494
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUpadacitinib
    D.3.9.1CAS number 1310726-60-3
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase (Jak) 1 inhibitor
    D.IMP: 2
    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 nameUpadacitinib
    D.3.2Product code ABT-494
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUpadacitinib
    D.3.9.1CAS number 1310726-60-3
    D.3.9.3Other descriptive nameABT-494
    D.3.9.4EV Substance CodeSUB125895
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeJanus Kinase (Jak) 1 inhibitor
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's Disease (CD)
    E.1.1.1Medical condition in easily understood language
    CD is an inflamatory bowel disease affects the lining of the digestive tract, often spreads into the layers of affected bowel tissue, can lead to abdominal pain, severe diarrhea, fatigue, weight loss.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Substudy 1 (randomized, double-blind, placebo-controlled maintenance): To evaluate the efficacy and safety of two doses of upadacitinib versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to upadacitinib induction treatment in Studies M14-431 or M14-433.
    Substudy 2 (long-term extension [LTE]): To evaluate safety and efficacy of long-term administration of upadacitinib in subjects with moderately to severely active CD who participated in the Phase 3 upadacitinib induction and maintenance studies.
    Subestudio 1 (de mantenimiento, aleatorizado, doble ciego y controlado con placebo): evaluar la eficacia y seguridad de dos dosis de upadacitinib frente a placebo como terapia de mantenimiento en sujetos con Enfermedad de Crohn de moderada a severamente activa (CD) que respondieron al tratamiento de inducción con upadacitinib en los estudios M14-431 o M14-433.
    Subestudio 2 (extensión a largo plazo [LTE]): evaluar la seguridad y eficacia de la administración de upadacitinib a largo plazo en sujetos con EC de moderada a severamente activa que participaron en los estudios de inducción y mantenimiento de upadacitinib de fase 3.
    E.2.2Secondary objectives of the trial
    To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.
    Evaluar las mejoras en varios parámetros de eficacia, incluidos la interrupción de esteroides, los parámetros de laboratorio y los cuestionarios de calidad de vida.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudy 1 - 52-Week, Randomized, Double-Blind, Maintenance
    Substudy 2 - 240-Week Long-Term-Extension
    Subestudio 1 - 52 semanas, aleatorizado, doble ciego, de mantenimiento
    Subestudio 2 - Extensión a largo plazo de 240 semanas
    E.3Principal inclusion criteria
    For Substudy 1:
    - Participant who receive double-blind treatment in Study M14- 431 or Study M14-433 and achieve clinical response.
    - Participant completes Week 12 or Week 24 study procedures
    For Substudy 2:
    - Participant completes Substudy 2
    - Participant who receive open-label upadacitinib Dose B in Study M14-431 and achieve clinical response.
    - Participant completes study procedures in the parent study/substudy.
    Para el Subestudio 1:
    - Participante que recibe tratamiento doble ciego en el Estudio M14-431 o Estudio M14-433 y alcanza respuesta clínica.
    - Participante que completa los procedimientos del estudio de la semana 12 o la semana 24
    Para el Subestudio 2:
    - Participante que completa el Subestudio 2
    - Participante que recibe de forma abierta la dosis B de upadacitinib en el Estudio M14-431 y alcanza respuesta clínica.
    - Participante que completa los procedimientos del estudio en el estudio/subestudio principal.
    E.4Principal exclusion criteria
    For Sub-studies 1 and 2:
    - Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
    - Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Study M14-431 or Substudy 1 of Study M14-430 that in the investigator's judgment makes the subject unsuitable for this study.
    - Participant with any active or chronic recurring infections based on the investigator's assessment that makes the subject an unsuitable candidate for the study. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is cured, based on the investigator's assessment.
    - Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Study M14-431 (Week 24) or Substudy 1 of Study M14-430 (Week 40).
    Para los estudios secundarios 1 y 2:
    - Participante que, por cualquier motivo, es considerado un candidato inadecuado para el estudio por parte del investigador.
    - Participante que presenta una hipersensibilidad conocida a upadacitinib o sus excipientes, o que tuvo un evento adverso durante el Estudio M14-431 o Subestudio 1 del Estudio M14-430 que, a juicio del investigador, hace que el sujeto no sea apto para este estudio.
    - Participante con cualquier infección recurrente activa o crónica, basada en el criterio del investigador, que hace que el sujeto sea un candidato inadecuado para el estudio. Los sujetos con infecciones en curso que se someten a tratamiento pueden inscribirse PERO NO medicarse hasta que el tratamiento de la infección se haya completado y la infección esté curada, según la evaluación del investigador.
    - Participantes con displasia o malignidad colónica de alto grado diagnosticada en la endoscopia realizada en la visita final del Estudio M14-431 (Semana 24) o Estudio secundario 1 del Estudio M14-430 (Semana 40).
    E.5 End points
    E.5.1Primary end point(s)
    Substudy 1, Cohort 1 (Upadacitinib vs Placebo)
    Co-Primary Endpoints:
     Proportion of subjects with clinical remission at Week 52, AND
     Proportion of subjects with endoscopic response at Week 52

    Substudy 2
    Primary Endpoint: Incidence of AEs over time
    Subestudio 1, Cohorte 1 (Upadacitinib vs Placebo)
    Criterios de valoración principales:
    • Proporción de sujetos con remisión clínica en la semana 52, y
    • Proporción de sujetos con respuesta endoscópica en la semana 52
    Subestudio 2
    Criterio de valoración principal: Incidencia de EAs en el tiempo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    Substudy 1
    1. Proportion of subjects with clinical remission per CDAI (CDAI < 150) at Week 52 in subjects with CDAI of 220 to 450 at Baseline of induction study
    2. Proportion of subjects with clinical remission at Week 0 and Week 52
    3. Proportion of subjects with endoscopic remission at Week 52
    4. Proportion of subjects who discontinue corticosteroid use for CD and achieve clinical remission at Week 52 in subjects taking corticosteroids for CD at Baseline of induction
    5. Proportion of subjects who discontinued corticosteroid use for CD at Week 52 in subjects taking corticosteroids for CD at Baseline of induction
    6. Proportion of subjects with enhanced clinical response at Week 52
    7. Proportion of subjects with clinical remission and endoscopic remission at Week 0 and Week 52
    8. Proportion of subjects with ≥ 50% reduction in draining fistulas at Week 12 in subjects with fistulas at Baseline
    9. Proportion of subjects with draining fistulas at Week 52 in subjects with draining fistulas at Baseline of induction study
    10. Change from Week 0 in Crohn's Symptoms Severity (CSS) Questionnaire at Week 52
    11. Proportion of subjects with CD-related hospitalizations during the 52-Week double blind maintenance period.
    12. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
    13. Change from Baseline in Short Form-36 (SF-36) at Week 52
    Substudy 2
    Proportion of subjects
     with clinical remission over time
     with enhanced clinical response over time
     with endoscopic remission at Week 0, and every 48 weeks thereafter
     with endoscopic response at Week 0, and every 48 weeks thereafter
     who discontinue corticosteroid use and achieve clinical remission over time among subjects taking steroids at Baseline (of induction)
     with clinical remission over time who were in clinical remission at Week 0
     achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response (increase of IBDQ ≥ 16 over time)
    Time loss of
     enhanced clinical response
     clinical remission
    Subestudio 1
    1. Proporción de sujetos con remisión clínica por CDAI (CDAI <150) en la semana 52, en sujetos con CDAI de 220 a 450 al inicio del estudio de inducción
    2. Proporción de sujetos con remisión clínica en la semana 0 y semana 52
    3. Proporción de sujetos con remisión endoscópica en la semana 52
    4. Proporción de sujetos que interrumpen el uso de corticosteroides para la EC y logran la remisión clínica en la semana 52, en sujetos que toman corticosteroides para la EC al inicio del estudio de inducción
    5. Proporción de sujetos que suspendieron el uso de corticosteroides para la EC en la semana 52, en sujetos que tomaron corticosteroides para la EC al inicio del estudio de inducción
    6. Proporción de sujetos con respuesta clínica mejorada en la semana 52
    7. Proporción de sujetos con remisión clínica y remisión endoscópica en la semana 0 y la semana 52
    8. Proporción de sujetos con una reducción ≥ 50% en las fístulas de drenaje en la semana 12, en sujetos con fístulas al inicio del estudio
    9. Proporción de sujetos con fístulas de drenaje en la semana 52, en sujetos con fístulas de drenaje al inicio del estudio de inducción
    10. Cambios en el Cuestionario de Severidad de los Síntomas de Crohn (CSS) desde la semana 0 a la Semana 52
    11. Proporción de sujetos con hospitalizaciones relacionadas con EC durante el período de mantenimiento doble ciego de 52 semanas
    12. Cambios, desde la visita inicial, en la evaluación funcional de la terapia de enfermedades crónicas: fatiga (FACIT-F) en la semana 52
    13. Cambios, desde la visita inicial, en el Short Form-36 (SF-36) en la semana 52
    Subestudio 2
    Proporción de sujetos:
    • con remisión clínica a lo largo del tiempo
    • con una respuesta clínica mejorada en el tiempo
    • con remisión endoscópica en la semana 0, y cada 48 semanas a partir de entonces
    • con respuesta endoscópica en la semana 0, y cada 48 semanas a partir de entonces
    • que interrumpen el uso de corticosteroides y logran remisión clínica a lo largo del tiempo entre los sujetos que toman esteroides al inicio del estudio (de inducción)
    • con remisión clínica en el tiempo, que estaban en remisión clínica en la semana 0
    • que logran una respuesta al Cuestionario de Enfermedad Inflamatoria Intestinal (IBDQ) (aumento de IBDQ ≥ 16 a lo largo del tiempo)
    Pérdida de tiempo de
    • respuesta clínica mejorada
    • remisión clínica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Substudy 1
    1. week 52
    2. week 52
    3. week 52
    4. week 52
    5. week 52
    6. week 52
    7. week 52
    8. week 12
    9. week 52
    10. week 52
    11. week 52
    12. week 52
    13. week 52
    Substudy 2
    Over study duration
    Subestudio 1
    1. semana 52
    2. semana 52
    3. semana 52
    4. semana 52
    5. semana 52
    6. semana 52
    7. semana 52
    8. semana 12
    9. semana 52
    10. semana 52
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Substudy 1 Randomized, double-blind. Substudy 2 Both open-label and double-blind
    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 trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA146
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belarus
    Bosnia and Herzegovina
    Brazil
    Canada
    Chile
    China
    Colombia
    Egypt
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    New Zealand
    Russian Federation
    Serbia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United States
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days12
    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: 731
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 457
    F.4.2.2In the whole clinical trial 738
    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)
    This study will be active until upadacitinib is approved. Subject may continue to receive upadacitinib once available in the approved country, or have the treatment change to standard of care, per the investigatory decision.
    Este estudio estará activo hasta que se apruebe upadacitinib. El sujeto puede continuar recibiendo upadacitinib una vez que esté comercializado en su país, o cambiar al tratamiento estándar, según la decisión de la investigación
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-26
    P. End of Trial
    P.End of Trial StatusOngoing
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