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    Summary
    EudraCT Number:2016-002004-10
    Sponsor's Protocol Code Number:15-007
    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:2016-08-05
    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 number2016-002004-10
    A.3Full title of the trial
    A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant
    Estudio adaptativo y aleatorizado de fase 3 para comparar la eficacia y la seguridad de Defibrotide frente al mejor tratamiento de soporte en la prevención de la enfermedad venooclusiva hepática en pacientes adultos y pediátricos sometidos a un trasplante hematopoyético de células madre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the efficacy and safety of Defibrotide compared with Best Supportive Care in the prevention of Hepatic Veno-Occlusive Disease in adult and pediatric patients Undergoing Hematopoietic Stem Cell Transplant.
    Ensayo clínico para investigar la eficacia y seguridad de Defibrotide en comparación con el mejor tratamiento de soporte en la prevención de la enfermedad venooclusiva hepática en pacientes adultos y pediátricos sometidos a un trasplante hematopoyético de células madre.
    A.4.1Sponsor's protocol code number15-007
    A.5.4Other Identifiers
    Name:INDNumber:62,118
    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 SponsorJazz 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 supportJazz Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJazz Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address3180 Porter Drive
    B.5.3.2Town/ cityPalo Alto
    B.5.3.3Post codeCA 94304
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 Yes
    D.2.1.1.1Trade name Defitelio
    D.2.1.1.2Name of the Marketing Authorisation holderGentium Srl, Italy
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/211
    D.3 Description of the IMP
    D.3.1Product nameDefibrotide
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNDEFIBROTIDE
    D.3.9.1CAS number 83712-60-1
    D.3.9.3Other descriptive name"Defibrotide sodium"
    D.3.9.4EV Substance CodeSUB01572MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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.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
    Prevention of Hepatic Veno-Occlusive Disease following Hematopoietic Stem Cell Transplant
    Prevención de la enfermedad venooclusiva hepática tras un trasplante hematopoyético de células madre
    E.1.1.1Medical condition in easily understood language
    Prevention of Hepatic Veno-Occlusive Disease
    Prevención de la enfermedad venooclusiva hepática
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10047207
    E.1.2Term Veno-occlusive liver damage
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10047217
    E.1.2Term Venoocclusive syndrome of the liver
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10047216
    E.1.2Term Venoocclusive liver disease
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the efficacy of defibrotide vs Best Supportive Care for the prevention of Veno-Occlusive Disease (VOD) as measured by VOD-free survival by Day +30 post-HSCT in patients who are at high risk or very high risk for developing VOD.
    El objetivo principal del estudio es comparar la eficacia del defibrotide frente al mejor tratamiento de soporte (MTS) para la prevención de la enfermedad venooclusiva (EVO) valorada en función de la supervivencia libre de EVO el día +30 post-TCMH en pacientes que presentan un riesgo alto o muy alto de desarrollo de EVO.
    E.2.2Secondary objectives of the trial
    The key secondary objective of the study is to compare the efficacy of defibrotide vs BSC for the prevention of VOD as measured by VOD-free survival by Day +100 post-HSCT in patients who are at high risk or very high risk for developing VOD
    El objetivo secundario fundamental del estudio es comparar la eficacia del defibrotide frente al MTS para la prevención de la EVO valorada en función de la supervivencia libre de EVO el día +100 post-TCMH en pacientes que presentan un riesgo alto o muy alto de desarrollo de EVO.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be above the age of 1 month as of the start date of study treatment.
    2. Patient must be scheduled to undergo allogeneic (adults or pediatric patients) or autologous HSCT (pediatric patients only) and be at high risk or very high risk of developing VOD.
    a. High-risk patients must meet both of the following criteria (i and ii):
    i. Patient must be scheduled to receive myeloablative conditioning, defined as either of the following:
    a. At least 2 alkylating agents (e.g., cyclophosphamide, busulfan, melphalan); the investigator must document in the medical chart that the conditioning regimen is considered to be myeloablative
    or
    b. TBI (single dose of ≥5 Gy, or ≥8 Gy fractionated dose) and at least 1 alkylating agent, and
    ii. Patient must meet at least 1 of the following criteria (a or b):
    a. Have at least 1 hepatic-related risk factor, as defined by the EBMT position statement at screening:
    • Transaminase level >2.5 times the upper limit of normal (ULN)
    • Serum total bilirubin level >1.5 times the ULN
    • Cirrhosis (with biopsy evidence)
    • Hepatic fibrosis (by histology)
    • Known history of active viral hepatitis within 1 year before the start of study treatment, as indicated by an available positive test result for any of the following: hepatitis A virus (HAV) immunoglobulin M (IgM) antibody; hepatitis B virus (HBV) core IgM antibody; HBV surface antigen; hepatitis C virus (HCV) antibody with HCV polymerase chain reaction (PCR) test (or HCV PCR alone)
    • Any prior hepatic irradiation, including abdominal irradiation covering the hepatic area
    • Documented diagnosis of iron overload (serum ferritin >2000 ng/mL)
    or
    b. Has advanced-stage neuroblastoma requiring myeloablative conditioning
    b. Very high-risk patients must meet one of the following criteria:
    i. Osteopetrosis and undergoing myeloablative conditioning
    ii. Primary HLH, Griscelli II Chediak-Higashi syndrome, Hermansky-Pudiak II, X-linked lymphoproliferative disorders, X-linked severe combined immunodeficiency, X-linked hypogammaglobulinemia, or familial HLH 1-5 and undergoing myeloablative conditioning
    iii.Prior treatment with an ozogamicin-containing monoclonal antibody using the minimum dose and schedule, according to the patient prescribong information;
    iv.Class III, high-risk thalassemia (i.e., patients who are ≥7 years old and have a liver size ≥5 cm at the time of screening
    3. Female patients of childbearing potential who are sexually active must agree to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the last dose of study drug; male patients with female partners of childbearing potential must agree to use a medically acceptable method of contraception for 6 months after the last dose of study drug. Medically acceptable methods of
    contraception that may be used by the patient and/or partner include abstinence, birth control pills, patches, vaginal ring, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, vasectomy (>6 months before Study Day 1), and progestin implant or injection. Post-menopausal women (i.e., women with >2 years of amenorrhea) do not need to use contraception.
    4. Patient and/or the legal guardian or representative must be able to understand and sign a written informed consent. Assent, when appropriate.
    1. El paciente deberá tener más de 1 mes de edad en el momento de la fecha de inicio del tratamiento del estudio.
    2. El paciente debe tener programado someterse a un TCMH alógeno o autógeno (pacientes adultos o pediátricos) o un TCMH autógeno (solo pacientes pediátricos) y tener un riesgo alto o muy alto de desarrollo de EVO.
    a. Los pacientes con un riesgo alto deben cumplir los dos criterios siguientes (i y ii):
    i. El paciente debe tener programada la recepción de un acondicionamiento mieloablativo, definido como una de las dos opciones siguientes:
    a. Al menos dos fármacos alquilantes (p. ej., ciclofosfamida, busulfano, melfalán); el investigador deberá documentar en la historia clínica que el tratamiento de acondicionamiento se considera mieloablativo.
    O bien
    b. Irradiación corporal total (dosis única ≥ 5 Gy o dosis fraccionada ≥ 8 Gy) y al menos un fármaco alquilante, y
    ii. El paciente debe cumplir al menos uno de los siguientes criterios (a o b):
    a. Tener al menos un factor de riesgo hepático, tal como se define en la declaración de posición de la EBMT en la visita de selección:
    • Nivel de transaminasas > 2,5 veces el límite superior de la normalidad (LSN).
    • Nivel de bilirrubina sérica total > 1,5 veces el LSN.
    • Cirrosis (confirmada por biopsia).
    • Fibrosis hepática (con confirmación histológica).
    • Antecedentes conocidos de hepatitis viral activa en el año anterior al inicio del tratamiento del estudio, basados en un resultado positivo para cualquiera de las pruebas siguientes: anticuerpos de tipo inmunoglobulina M (IgM) contra el virus de la hepatitis A (VHA), anticuerpos de tipo IgM contra el antígeno central del virus de la hepatitis B (VHB) y anticuerpos contra el antígeno de superficie del virus de la hepatitis C (VHC) mediante una prueba de reacción en cadena de la polimerasa (PCR) (o solo PCR para el VHC).
    • Cualquier irradiación hepática previa, incluida la irradiación abdominal que cubra el área hepática.
    • Diagnóstico documentado de sobrecarga de hierro (ferritina sérica > 2000 ng/ml).
    O bien
    b. Tener un neuroblastoma en estadio avanzado que requiera acondicionamiento mieloablativo.
    b. Los pacientes con un riesgo muy alto deben cumplir uno de los criterios siguientes:
    i. Osteopetrosis y recepción de acondicionamiento mieloablativo.
    ii. Linfohistiocitosis hemofagocítica (LHH) primaria, síndrome de Griscelli de tipo II, síndrome de Chediak-Higashi, síndrome de Hermansky-Pudiak de tipo II, trastornos linfoproliferativos ligados al cromosoma X, inmunodeficiencia combinada grave ligada al cromosoma X, hipogammaglobulinemia ligada al cromosoma X o LHH de tipos 1-5 y recepción de acondicionamiento mieloablativo.
    iii. Tratamiento previo con un anticuerpo monoclonal que contenga ozogamicina utilizando la dosis y la pauta mínimas, conforme a la información de prescripción para el paciente.
    iv. Talasemia de clase III de alto riesgo (es decir, pacientes ≥7 años que tienen un tamaño del hígado ≥ 5 cm en el momento de la selección.
    3. Las pacientes con capacidad de procrear que sean sexualmente activas deben comprometerse a usar un método anticonceptivo médicamente aceptable durante todo el período del estudio y durante 4 semanas después de la última dosis del fármaco del estudio; los pacientes que tengan parejas femeninas con capacidad de procrear deben comprometerse a usar un método anticonceptivo médicamente aceptable durante 6 Meses después de la última dosis del fármaco del estudio. Los métodos anticonceptivos médicamente aceptables que pueden usar el/la paciente y/o su pareja son la abstinencia, la píldora anticonceptiva, los parches anticonceptivos, el anillo vaginal, el diafragma más espermicida, el preservativo más espermicida vaginal, la esterilización quirúrgica, la vasectomía (> 6 meses antes del día 1 del estudio) y los implantes o inyecciones de gestágenos. Las mujeres posmenopáusicas (es decir, aquellas que lleven > 2 años de amenorrea) no necesitan usar métodos anticonceptivos.
    4. El paciente y/o el tutor o representante legal deben ser capaces de comprender y firmar un documento de consentimiento informado por escrito. Cuando proceda, se obtendrá el asentimiento.
    E.4Principal exclusion criteria
    1. Patient has hemodynamic instability within 24 hours before the start of study treatment.
    2. Patient has acute bleeding that is clinically significant within 24 hours before the start of study treatment, defined as either of the following:
    a. hemorrhage requiring >15 cc/kg of packed red blood cells (e.g., pediatric patient weighing 20 kg and requiring 300 cc packed red blood cells/24 hours, or an adult weighing >70 kg and requiring 3 units of packed red blood cells/24 hours) to replace blood loss, or
    b. bleeding from a site which, in the investigator’s opinion, constitutes a potential life-threatening source (e.g., pulmonary hemorrhage or central nervous system bleeding), irrespective of amount of blood loss
    3. Patient used any medication that increases the risk of bleeding within 24 hours before the start of study treatment, including, but not limited to, systemic heparin, low molecular weight heparin, heparin analogs, alteplase, streptokinase, urokinase, ATIII, and oral anticoagulants including warfarin, and other agents that increase the risk of bleeding.
    Note: Heparin used to keep catheters open will be allowed (up to a maximum of 100 U/kg/day).
    4. Patient is using or plans to use an investigational agent for the prevention or treatment of VOD.
    5. Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
    6. Patient has a psychiatric illness that would prevent the patient or legal guardian or representative from giving informed consent and/or assent.
    7. Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.
    8. Patient is pregnant or lactating and does not agree to stop breastfeeding.
    1. El paciente presenta inestabilidad hemodinámica en las 24 horas anteriores al inicio del tratamiento del estudio.
    2. El paciente presenta hemorragia agua clínicamente significativa en las 24 horas anteriores al inicio del tratamiento del estudio, definida como una de las siguientes opciones:
    a. Hemorragia que requiere > 15 ml/kg de concentrado de hematíes (p. ej., paciente pediátrico que pesa 20 kg y requiere 300 ml de concentrado de hematíes cada 24 horas, o paciente adulto que pesa > 70 kg y requiere 3 unidades de concentrado de hematíes cada 24 horas) para reponer la pérdida de sangre.
    b. Hemorragia originada en un lugar que, en opinión del investigador, podría poner en peligro la vida del paciente (p. ej., hemorragia pulmonar o hemorragia en el sistema nervioso central), independientemente de la cantidad de pérdida de sangre.
    3.El paciente ha usado algún medicamento que aumenta el riesgo de hemorragia en las 24 horas anteriores al inicio del tratamiento del estudio, tal como heparina sistémica, heparina de bajo peso molecular, análogos de la heparina, alteplasa, estreptoquinasa, uroquinasa, ATIII, anticoagulantes orales como la warfarina, y otros fármacos que aumentan el riesgo de hemorragia.
    Nota: Se permitirá el uso de heparina para mantener abiertos los catéteres (hasta 100 U/kg al día).
    4. El paciente está usando o tiene previsto usar un fármaco en investigación para la prevención o el tratamiento de la EVO.
    5. El paciente, en opinión del investigador, podría no ser capaz de cumplir los requisitos del estudio relativos a la vigilancia de la seguridad.
    6. El paciente padece una enfermedad psiquiátrica que impediría al paciente o a su tutor o representante legal dar su consentimiento y/o asentimiento informado.
    7. El paciente padece una enfermedad activa grave o un trastorno médico concomitante que, en opinión del investigador, interferiría en la realización del estudio.
    8. La paciente está embarazada o lactando y no acepta suspender la lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the VOD-free survival rate by Day +30 post-HSCT, as adjudicated by the independent Endpoint Adjudication Committee (EPAC).
    El criterio de valoracion principal de eficacia es la proporción de la supervivencia libre de EVO el día +30 post-TCMH, según la adjudicación de un Comité Independiente de Adjuducación de Criterios de valoración (CACV).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day +30 post- HSCT
    Día +30 post-TCMH
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoint is VOD-free survival by Day +100 post-HSCT
    El segundo criterio de valoracion principal de eficacia es la supervivencia libre de EVO el día +100 post-TCMH.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day +100 post-HSCT
    Día +100 post-TCMH
    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 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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Ensayo Clínico Adaptativo
    Adaptive Clinical Trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Singapore
    Spain
    Turkey
    United Kingdom
    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
    LPLV
    Última Visita del Último Paciente (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years5
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 195
    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: 65
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 65
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 65
    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: 25
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants, children for whom the parent(s) or legal guardian will need to give consent and the child and Adolescent itself assent as required
    Bebés, niños para los que se necesitará que el/los padre (s) o tutor legal dé su consentimiento y el asentimiento del niño y del adolescente en sí es requerido.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state74
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 144
    F.4.2.2In the whole clinical trial 400
    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
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-20
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