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    Summary
    EudraCT Number:2014-000584-41
    Sponsor's Protocol Code Number:BP-004
    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:2017-03-21
    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 number2014-000584-41
    A.3Full title of the trial
    Phase II extension study of CaspaCIDe T cells (BPX-501) from an HLA-partially matched family donor after negative selection of TCR αβ+T cells in pediatric patients affected by hematological disorders
    Estudio de extensión fase II de linfocitos T con CaspaCide (BPX-501) de un donante emparentado parcialmente compatible respecto al HLA tras selección negativa de linfocitos T TCR αβ+ en pacientes pediátricos afectados de trastornos hematológicos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II extension study of CaspaCIDe T cells (BPX-501) from an HLA-partially matched family donor after negative selection of TCR αβ+T cells in pediatric patients affected by hematological disorders
    Estudio de extensión fase II de linfocitos T con CaspaCide (BPX-501) de un donante emparentado parcialmente compatible respecto al HLA tras selección negativa de linfocitos T TCR αβ+ en pacientes pediátricos afectados de trastornos hematológicos
    A.3.2Name or abbreviated title of the trial where available
    CaspaCide TCR αβ haplo HSCT
    CaspaCide TCR αβ haplo HSCT
    A.4.1Sponsor's protocol code numberBP-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02065869
    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 SponsorBellicum Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportBellicum Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeon Research S.L.
    B.5.2Functional name of contact pointRocío García Cañamaque
    B.5.3 Address:
    B.5.3.1Street AddressAvda Ordoño II, 37-2ºDcha
    B.5.3.2Town/ cityLeon
    B.5.3.3Post code24001
    B.5.3.4CountrySpain
    B.5.4Telephone number0034987261 064
    B.5.5Fax number0034987216 243
    B.5.6E-mailrgcanamaque@leonresearch.es
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1674
    D.3 Description of the IMP
    D.3.1Product nameBPX-501 cells
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNrivogenleucleucel
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeBPX-501
    D.3.9.3Other descriptive nameBPX-501
    D.3.9.4EV Substance CodeSUB171410
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1666
    D.3 Description of the IMP
    D.3.1Product nameAP1903
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNRimiducid
    D.3.9.1CAS number 195514-63-7
    D.3.9.2Current sponsor codeAP1903
    D.3.9.3Other descriptive nameAP1903
    D.3.9.4EV Substance CodeSUB171411
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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
    Hematological disorders (ALL;AML;Non-Hodgkin lymphoma;Myelodysplastic
    syndromes;Congenital immune deficiencies;Severe aplastic anemia;Fanconi anemia; Osteopetrosis;Selected cases of hemoglobinopathies)
    Trastornos hematológicos (ALL, AML, linfoma no Hodgkin; síndromes mielodisplásicos; inmunodeficiencias congénitas; anemia aplásica severa, anemia de Fanconi; Osteopetrosis; Casos seleccionados de hemoglobinopatías);
    E.1.1.1Medical condition in easily understood language
    Hematological disorders
    Desórdenes hematológicos
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level HLGT
    E.1.2Classification code 10018849
    E.1.2Term Haematological disorders NEC
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a Phase II study to determine whether BPX-501 and rimiducid will improve event free survival – events defined as TRM (or NRM) at 180 days, severe GVHD (acute Grade 2-4 organ or extensive chronic GVHD) and life threatening infections (Grade 4). To evaluate the safety of the infusion of BPX-501 gene modified T cells after mismatched, T depleted allogeneic transplantation. To determine safety by evaluating the overall incidence of GVHD after infusion of AP1903.

    Este es un estudio Fase II para determinar si BPX-501 y rimiducid mejorarán la supervivencia libre de acontecimientos, definidos estos como mortalidad relacionada con el trasplante (MRT) (o mortalidad sin recidiva, MSR) a los 180 días, enfermedad del injerto contra el huésped (EICH) grave (EICH aguda del órgano de grado 2-4 o crónica extendida) e infecciones potencialmente mortales (grado 4).Evaluar la seguridad de la infusión de linfocitos T modificados genéticamente BPX-501 tras un alotrasplante con reducción de linfocitos T de donante incompatible. Determinar la seguridad mediante la evaluación de la incidencia global de EICH tras la infusión de AP1903.
    E.2.2Secondary objectives of the trial
    1.TRM (non-malignant) or NRM (malignant) at 100 and 180 days
    2.Cumulative incidence and severity of acute (grade 2-4) and chronic GvHD at 180 days;
    3.Time to resolution of acute GvHD after administration of AP1903
    4.Immune reconstitution as determined by T cell subsets at day 180
    a.Absolute CD3 count
    b.Absolute CD4 count
    c.Absolute CD8 count
    5.Time to immune reconstitution
    6.Disease Free/cGVHD survival at 180 days
    7.Disease status of each specific disease indication at 180 days:
    -Primary immune disorders as determined by CD3 T cell count >500 cells/ul and lower normal levels of IgA and IgM at 180 days
    -Haemoglobinopathies as determined by incidence of RBC transfusion dependence and haemoglobin of >8.5 g/dL at 180 days
    -Fanconi Anemia as determined by RBC >3,000,000 cells/ul, neutrophil count determined by 1500 cells/ul and >150,000 platelet counts at 180 days
    -Leukemia as determined by PFS at 180 days

    1.MRT (sin cáncer) o MSR (con cáncer) a los 100 y 180 días. 2.Incidencia acumulada y gravedad de la EICH aguda (grado 2-4) y crónica a los 180 días. 3.Tiempo hasta la resolución de la EICH aguda después de la administración de AP1903.4.Reconstitución inmunitaria, determinada según los subgrupos de linfocitos T el día 180.a.Recuento absoluto de CD3.b.Recuento absoluto de CD4.c.Recuento absoluto de CD8.5.Tiempo hasta la reconstitución inmunitaria.6.Supervivencia libre de enfermedad/EICH crónica a los 180 días.7.Estado de la enfermedad en función de cada enfermedad específica a los 180 días:
    (...)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age < 18 years and > 1 month (< 1 month upon approval by Applicant)
    2. Life expectancy > 10 weeks
    3. Patients deemed clinically eligible for allogeneic stem cell transplantation.
    4. Patients may have failed prior allograft
    5. Patients with life-threatening hematological malignancies (high-risk ALL in 1st CR, ALL in 2nd, high-risk AML in 1st CR, AML in 2nd CR;
    OR
    6. Non-malignant disorders deemed curable by allogeneic transplantation:
    • primary immune deficiencies,
    • severe aplastic anemia not responding to immune suppressive therapy,
    • osteopetrosis,
    • selected cases of hemoglobinopathies, for example, β0 β0 thalassemia major, sickle cell disease, Diamond- Blackfin
    • congenital/hereditary cytopenia, including Fanconi Anemia before any clonal malignant evolution (MDS, AML).
    7. Lack of suitable conventional donor (HLA identical sibling or HLA phenotypically identical relative or 10/10 unrelated donor evaluated using high resolution molecular typing) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
    8. A minimum genotypic identical match of 5/10 is required.
    9. The donor and recipient must be identical, as determined by high resolution typing, on at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA- DRB1.
    10. Lansky/Karnofsky score > 50
    1. Edad ≤ 18 años y ≥ 1 mes (< 1 mes tras la aprobación por el solicitante).
    2. Esperanza de vida > 10 semanas.
    3. Pacientes que se consideren clínicamente aptos para el alotrasplante de células madre.
    4. Pacientes con un alotrasplante anterior fallido.
    5. Pacientes con neoplasias hematológicas potencialmente mortales (leucemia linfocítica aguda [LLA] de alto riesgo en primera respuesta completa [RC], LLA en segunda RC, leucemia mieloide aguda [LMA] de alto riesgo en primera RC, LMA en segunda RC).
    O BIEN
    6. Enfermedades benignas que pueden curarse mediante alotrasplante:
    • inmunodeficiencias primarias,
    • anemia aplásica grave que no responde al tratamiento inmunosupresor,
    • osteopetrosis,
    • determinados casos de hemoglobinopatías, por ejemplo, talasemia mayor β0/β0, drepanocitemia, anemia de Diamond-Blackfan,
    • citopenia congénita/hereditaria, como anemia de Fanconi, antes de una evolución clonal maligna (síndrome mielodisplásico [SMD], LMA).
    7. Falta de donante convencional compatible (hermano con sistema HLA idéntico o pariente con sistema HLA idéntico desde el punto de vista fenotípico o donante no emparentado 10/10, evaluado mediante tipificación molecular de alta resolución) o presencia de enfermedad rápidamente progresiva que no ofrece margen para identificar a un donante no emparentado.
    8. Se requiere una compatibilidad genotípica idéntica mínima de 5/10.
    9. El donante y el receptor deben ser idénticos, según determine la tipificación de alta resolución, en al menos un alelo de cada uno de los siguientes locus genéticos: HLA-A, HLA-B, HLA-Cw y HLA-DRB1.
    10. Escala de Lansky/Karnofsky > 50.
    E.4Principal exclusion criteria
    1. Greater than ongoing Grade II acute GvHD or chronic extensive GvHD due to a previous allograft at the time of screening
    2. Patient receiving an immunosuppressive treatment for GvHD treatment due to a previous allograft at the time of screening
    3. Dysfunction of liver (ALT/AST > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance <30ml/min/1.73m2)
    4. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction < 40%)
    5. Current active infectious disease (including positive HIV serology or viral RNA)
    6. Serious concurrent uncontrolled medical disorder
    7. Pregnant or breast feeding female patient
    1. EICH aguda en curso de grado mayor de 2 o EICH crónica extendida debida a un alotrasplante previo en el momento de la selección.
    2. Paciente que esté recibiendo tratamiento inmunosupresor para tratar la EICH debida a un alotrasplante anterior en el momento de la selección.
    3. Disfunción hepática (ALT/AST > 5 veces el valor normal o bilirrubina > 3 veces el valor normal) o renal (aclaramiento de creatinina < 30 ml/min/1,73 m2).
    4. Enfermedad cardiovascular grave (arritmias con necesidad de tratamiento crónico, insuficiencia cardíaca congestiva o fracción de eyección del ventrículo izquierdo < 40 %).
    5. Enfermedad infecciosa activa actual (lo que incluye pruebas serológicas positivas de VIH o ARN vírico).
    6. Trastorno médico grave simultáneo no controlado.
    7. Paciente embarazada o lactante.
    E.5 End points
    E.5.1Primary end point(s)
    1. Cumulative incidence of infectious complications at 180 days
    a. Cumulative Incidence of clinically significant viral reactivations at 180 days
    b. Cumulative incidence of patients requiring antiviral treatment at 180 days
    c. Cumulative incidence of rehospitalizations due to viral infection by day 180
    d. Cumulative incidence of bacterial and fungal infections at 180 days
    e. Cumulative use of non-prophylactic antibiotic and antifungal use at 180 days
    1. Incidencia acumulada de complicaciones infecciosas a los 180 días
    a. Incidencia acumulativa de reactivaciones virales clínicamente significativas a los 180 días
    b. Incidencia acumulada de pacientes que requieren tratamiento antiviral a los 180 días
    c. Incidencia acumulada de rehospitalizaciones por infección viral al día 180
    d. Incidencia acumulada de infecciones bacterianas y fúngicas a los 180 días
    e. Uso acumulativo de antibióticos y antifúngicos no profilácticos a los 180 días
    E.5.1.1Timepoint(s) of evaluation of this end point
    180 days and up to 24 months post transplant
    Hasta 180 días u hasta 24 meses después del trasplante
    E.5.2Secondary end point(s)
    1.TRM (non-malignant) or NRM (malignant) at 100 and 180 days
    2.Cumulative incidence and severity of acute (grade 2-4) and chronic GvHD at 180 days;
    3.Time to resolution of acute GvHD after administration of AP1903
    4.Immune reconstitution as determined by T cell subsets at day 180
    a.Absolute CD3 count
    b.Absolute CD4 count
    c.Absolute CD8 count
    5.Time to immune reconstitution
    6.Disease Free/cGVHD survival at 180 days
    7.Disease status of each specific disease indication at 180 days:
    -Primary immune disorders as determined by CD3 T cell count >500 cells/ul and lower normal levels of IgA and IgM at 180 days
    -Haemoglobinopathies as determined by incidence of RBC transfusion dependence and haemoglobin of >8.5 g/dL at 180 days
    -Fanconi Anemia as determined by RBC >3,000,000 cells/ul, neutrophil count determined by 1500 cells/ul and >150,000 platelet counts at 180 days
    oLeukemia as determined by PFS at 180 days
    1.MRT (sin cáncer) o MSR (con cáncer) a los 100 y 180 días.
    2.Incidencia acumulada y gravedad de la EICH aguda (grado 2-4) y crónica a los 180 días.
    3.Tiempo hasta la resolución de la EICH aguda después de la administración de AP1903.
    4.Reconstitución inmunitaria, determinada según los subgrupos de linfocitos T el día 180.
    a.Recuento absoluto de CD3
    b.Recuento absoluto de CD4
    c.Recuento absoluto de CD8
    5.Tiempo hasta la reconstitución inmunitaria.
    6.Supervivencia libre de enfermedad/EICH crónica a los 180 días.
    7.Estado de la enfermedad en función de cada enfermedad específica a los 180 días:
    -Enfermedades autoinmunitarias primarias, determinado por un recuento de linfocitos T CD3 > 500 células/μl y niveles inferiores a los normales de IgA e IgM a los 180 días.
    -Hemoglobinopatías, determinado por la incidencia de dependencia de transfusiones de eritrocitos y valores de hemoglobina > 8,5 g/dl a los 180 días.
    -Anemia de Fanconi, determinado por un recuento de eritrocitos > 3 000 000 células/μl, un recuento de neutrófilos determinado por 1500 células/μl y recuentos de plaquetas > 150 000 a los 180 días.
    -Leucemia, determinado por la SLP a los 180 días.
    E.5.2.1Timepoint(s) of evaluation of this end point
    180 days
    180 dias
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    The study will be closed after evaluation of overall survival and disease free survival for all patients enrolled at 24 months after transplantation. The 15 year follow up data will be collected separately from the clinical trial data.
    El estudio se cerrará tras la evaluación de la supervivencia global y la supervivencia libre de enfermedad para todos los pacientes incluidos a los 24 meses después del trasplante. Los datos de seguimiento de 15 años se recogerán por separado de los datos de los ensayos clínicos.
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 170
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 60
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 80
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    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 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    Niños
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 175
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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