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    Summary
    EudraCT Number:2015-001611-12
    Sponsor's Protocol Code Number:56022473AML2002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-15
    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 number2015-001611-12
    A.3Full title of the trial
    A Randomized Phase 2 Study of DACOGEN® (Decitabine) Plus JNJ-56022473 (Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are not Candidates for Intensive Chemotherapy.
    Estudio fase 2 aleatorizado de DACOGEN® (decitabina) más JNJ-56022473 (anti-CD123) frente a DACOGEN (decitabina) en monoterapia, en pacientes con leucemia mieloide aguda (LMA) que no son candidatos a recibir quimioterapia intensiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.
    Estudio de eficacia y Seguridad de decitabina (DACOGEN®) más JNJ-56022473 (anti-CD123) frente a decitabina (DACOGEN®) administrado solo, en pacientes con leucemia mieloide aguda (LMA) no elegibles para recibir quimioterapia intensiva.
    A.4.1Sponsor's protocol code number56022473AML2002
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491722 8100
    B.5.5Fax number+3491722 8628
    B.5.6E-mailagonza45@its.jnj.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 nameJNJ-56022473
    D.3.2Product code JNJ-56022473
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeJNJ-56022473
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB176319
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name DACOGEN
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDACOGEN
    D.3.2Product code DACOGEN
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDECITABINE
    D.3.9.1CAS number 2353-33-5
    D.3.9.2Current sponsor codeDACOGEN
    D.3.9.3Other descriptive nameDACOGEN
    D.3.9.4EV Substance CodeSUB06932MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    Acute Myeloid Leukemia (AML)
    Leucemia Mieloide Aguda.
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia (AML)
    Leucemia Mieloide Aguda.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    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
    Part A: to assess the safety of JNJ-56022473 monotherapy and confirm the RP2D in subjects with AML for whom experimental therapy is appropriate (as assessed by their treating physician).
    Part B: The primary objective of the study is to assess the event-free survival (EFS) in subjects with previously untreated AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus JNJ 56022473 at the RP2D or decitabine alone.
    Parte A: evaluar la seguridad y confirmar la dosis recomendada para la fase 2 (DRF2) de JNJ-5602247 en monoterapia en pacientes con LMA para los que está indicado un tratamiento experimental (a criterio de su médico).

    Parte B: evaluar la supervivencia libre de eventos (SLE) en pacientes con LMA no tratados previamente que no son candidatos a la quimioterapia de inducción intensiva, asignados aleatoriamente para recibir decitabina más JNJ 56022473 a la DRF2 o decitabina sola.
    E.2.2Secondary objectives of the trial
    -To determine the overall response rate (ORR) defined as rate of complete response (CR) and complete response with incomplete blood count recovery (CRi);
    - To assess the relapse-free survival (RFS);
    - To assess overall survival (OS);
    - To assess the safety profile of JNJ-56022473 in combination with decitabine;
    - To assess the pharmacokinetics of JNJ-56022473 and decitabine alone and in combination;
    - To assess the immunogenicity of JNJ-56022473 alone and in combination with decitabine;
    - To assess patient-reported outcomes (PROs) using the FACT-Leu and EQ-5D-5L.
    - Determinar la tasa de respuesta global (TRG), definida como la tasa de respuesta completa (RC) y de respuesta completa con recuperación incompleta del hemograma (RCi);
    - Evaluar la supervivencia libre de recidiva (SLR)
    - Evaluar la supervivencia global (SG)
    - Evaluar el perfil de seguridad de JNJ-56022473 en combinación con decitabina;
    - Evaluar la farmacocinética de JNJ 56022473 y decitabina cuando se usan solos o en combinación;
    - Evaluar la inmunogenicidad de JNJ-56022473 cuando se usa solo o en combinación con decitabina;
    - Evaluar los resultados comunicados por los pacientes (RCP) aplicando los instrumentos FACT-LEU y EQ-5D-5L.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - De novo or secondary acute myeloid leukemia (AML) according to WHO 2008 criteria
    For Part A:
    - Participants With AML: treatment naive or relapsed for whom experimental therapy is appropriate (as assessed by their treating physician)
    For Part B:
    - Previously untreated AML (except: emergency leukapheresis and/or hydroxyurea during the screening phase to control hyperleukocytosis); Of note: treatment with hydroxyurea has to be discontinued at least one day prior to start of study therapy
    - Not eligible for standard intensive chemotherapy for induction and consolidation based on documented investigator assessment of disease- and patient characteristics as recorded in the electronic case report form (eCRF); these parameters include age, Eastern Cooperative Oncology Group (ECOG) performance status score, cytogenetic risk group, and comorbidities (cardiac, infectious, hepatic, diabetes-related, pulmonary, obesity-related, cerebrovascular accident-related, peptic-ulcer, and others)
    - Not eligible for an allogeneic hematopoietic stem cell transplantation
    - ECOG Performance Status score of 0, 1 or 2
    - A woman must be either: Not of childbearing potential: postmenopausal (more than [>] 45 years of age with amenorrhea for at least 12 months; If, of childbearing potential must be practicing a highly effective method of birth control
    - A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening
    - A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for at least 3 months after last study treatment
    - Leucemia mieloide aguda (LMA) de novo o secundaria de acuerdo con los criterios WHO 2008.

    Para la parte A:
    - Pacientes con LMA no tratados previamente o recidivantes en los que está indicado el tratamiento experimental (a criterio del médico responsable del tratamiento)

    Para la parte B:
    -Pacientes con LMA sin tratamiento previo (excepto: leucoféresis de urgencia o hidroxiurea durante la fase de selección para controlar la hiperleucocitosis); Nota: el tratamiento con hidroxiurea tiene que haber cesado al menos un día antes del inicio del tratamiento del estudio
    -No candidatos a quimioterapia intensiva estándar de inducción y consolidación en base a la evaluación de las características de la enfermedad y del paciente, realizada por el investigador y recogida en el cuaderno electrónico de recogida de datos (CRDe); estos parámetros incluyen edad, estado funcional según Eastern Cooperative Oncology Group (ECOG), grupo de riesgo en función de la citogenética y comorbilidades (cardiacas, infecciosas, hepáticas, relacionadas con diabetes, pulmonares, relacionadas con obesidad, relacionadas con accidente cerebrovascular, úlcera péptica, y otros)
    -No elegibles para trasplante alogénico
    -Estado funcional ECOG de 0, 1 o 2
    -Una mujer debe: No poder tener hijos: postmenopausica (más de [>] 45 años con amenorrea durante al menos 12 meses; Si, puede quedarse embarazada, debe usar un método anticonceptivo de alta efectividad
    -Una mujer en edad fértil que podría quedarse embarazada, debe tener un test de embarazo negativo en sangre (gonadotrofina coriónica humana beta [beta-hCG]) u orina en la fase de selección
    -Un hombre sexualmente activo con una mujer en edad fértil que no se ha sometido a una vasectomía, debe estar de acuerdo en usar un método anticonceptivo de barrera ej, preservativo en espuma/gel/película/crema/supositorio o pareja con capuchón (diafragma o cervical con espermicida en espuma/gel/película/crema/supositorio durante al menos 3 meses tras la última dosis de tratamiento
    E.4Principal exclusion criteria
    - Acute promyelocytic leukemia with t(15;17), or its molecular equivalent (PML-RARalpha)
    - For Part B only: Known leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system
    - In the case of AML from antecedent myelodysplastic syndrome (MDS), subjects who received prior treatment with a hypomethylating agent. For Part A, subjects with relapsed AML who received prior treatment with a hypomethylating agent
    - For Part A only: Subjects who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
    - For Part A only: Subjects who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
    - Any active infection that is not responding to treatment
    - Leucemia promielocítica aguda con t(15;17), o su equivalente molecular (PML-RARalpha)
    - Solo para la parte B: Infiltrado leucémico conocido o síntomas clínicos de infiltrado leucémico, a nivel del sistema nervioso central.
    - En caso de LMA precedida de syndrome mielodisplásico (SMD), pacientes que hayan recibido tratamiento previo con agentes hipometilantes.

    - Solo para la parte A: sujetos con LMA recidivante que hayan recibido tratamiento previo con agentes hipometilantes.
    - Solo para la parte A: sujetos que no se han recuperado hasta al menos un grado 1 de toxicidades clínicamente significativas (exluyendo alopecia y toxicidades hematológicas) de cualquier cirugía previa, radioterapia, terapia diana, o quimioterapia;
    - Cualquier infección active que no responde a tratamiento
    E.5 End points
    E.5.1Primary end point(s)
    Event-Free Survival
    Supervivencia libre de evento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 1 year after last participant enrolled
    Hasta 1 año tras la inclusión del último participante
    E.5.2Secondary end point(s)
    - Overall response rate (ORR)
    - Overall Survival (OS)
    - Relapse-free survival (RFS)
    - Number of Participants With Adverse Event
    - Pharmacokinetic parameters
    - Number of Participants With Anti-drug Antibody at any Visit
    - Functional Assessment of Cancer Therapy -Leukemia (FACT-Leu) Score
    - European Quality of Life- 5 Dimension 5-Level (EQ-5D-5L) Score
    Tasa de respuesta global (TRG)
    Supervivencia global (SG)
    Supervivencia libre de recidiva
    Número de participantes con acontecimientos adversos
    Parámetros farmacocinéticos
    Número de participantes con anticuerpos anti-medicación en cualquiera de las visitas
    Puntuación del Functional Assessment of Cancer Therapy -Leukemia (FACT-Leu)
    Puntuación del European Quality of Life- 5 Dimension 5-Level (EQ-5D-5L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Up to 1 year after last participant enrolled
    - Up to 1 year after last participant enrolled
    - Up to 1 year after last participant enrolled
    - Up to 1 year after last participant enrolled
    - Predose (0) hour and after intravenous infusion
    - Up to 1 year after last participant enrolled
    - Up to 1 year after last participant enrolled
    - Baseline and 1 year after last participant enrolled
    Hasta 1 año tras la inclusión del último participante
    Hasta 1 año tras la inclusión del último participante
    Hasta 1 año tras la inclusión del último participante
    Hasta 1 año tras la inclusión del último participante
    Pre-dosis (0) y tras la infusión intravenosa
    Hasta 1 año tras la inclusión del último participante
    Hasta 1 año tras la inclusión del último participante
    Basal y 1 año tras la inclusión del último participante
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Biomarker, Bio-equivalence
    Inmunogenicidad, biomarcadores, bioequivalenvia
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    DACOGEN
    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 EEA12
    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
    Australia
    Belgium
    Germany
    Israel
    Russian Federation
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as 12 months after the last subject is randomized providing all events have been reached. At that time, follow up of subjects and data collection will end. Subjects who are continuing to derive benefit from treatment as assessed by their investigator and confirmed by the study evaluation yteam will continue to receive treatment and be monitored for safety by the sponsor.
    El final del ensayo se define como 12 meses tras la aleatorización del ultimo paciente habiendose alcanzado todos los eventos. En ese momento, el seguimiento de los pacientes y la recogida de datos terminarán. Los sujetos que continúen obteniendo beneficio derivado del tratamiento, según la evaluación del investigador y la confirmación del equipo de evaluación del ensayo, continuarán recibiendo el tratamiento y serán monitorizados por el promotor para seguridad.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 126
    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)
    The end of the study is defined as 12 months after the last subject is randomized providing all events have been reached. At that time, follow up of subjects and data collection will end. Subjects who are continuing to derive benefit from treatment as assessed by their investigator and confirmed by the study evaluation team will continue to receive treatment and be monitored for safety by the sponsor.
    El final del ensayo se define como 12 meses tras la aleatorización del ultimo paciente habiendose alcanzado todos los eventos. En ese momento, el seguimiento de los pacientes y la recogida de datos terminarán. Los sujetos que continúen obteniendo beneficio derivado del tratamiento, según la evaluación del investigador y la confirmación del equipo de evaluación del ensayo, continuarán recibiendo el tratamiento y serán monitorizados por el promotor para seguridad.
    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 Decision2015-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-25
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