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    Summary
    EudraCT Number:2014-003563-38
    Sponsor's Protocol Code Number:20140159
    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:2015-04-14
    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 number2014-003563-38
    A.3Full title of the trial
    A Multicenter Single-arm Extension Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary
    Hyperparathyroidism in Pediatric Subjects With Chronic Kidney Disease on Dialysis
    Estudio de extensión, multicéntrico y de un solo brazo para evaluar la seguridad a largo plazo de cinacalcet HCl en el tratamiento del hiperparatiroidismo secundario en sujetos pediátricos con insuficiencia renal crónica sometidos a diálisis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Characterize the Long-term Safety of Cinacalcet Hydrochloride in the Treatment of Secondary Hyperparathyroidism in Children With Chronic Kidney Disease On Dialysis
    Estudio para evaluar la seguridad a largo plazo de cinacalcet HCl en el tratamiento del hiperparatiroidismo secundario en niños con insuficiencia renal crónica sometidos a diálisis
    A.4.1Sponsor's protocol code number20140159
    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 SponsorAmgen, 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 supportAmgen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH-)6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34900 850 153
    B.5.6E-mailMedinfoInternational@amgen.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 namecinacalcet hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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 INNcinacalcet
    D.3.9.1CAS number 364782-34-3
    D.3.9.2Current sponsor codeAMG 073
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 namecinacalcet hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Suspension and effervescent granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNcinacalcet
    D.3.9.1CAS number 364782-34-3
    D.3.9.2Current sponsor codeAMG 073
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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.IMP: 3
    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 namecinacalcet hydrochloride
    D.3.2Product code AMG 073
    D.3.4Pharmaceutical form Film-coated 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 INNCinacalcet
    D.3.9.1CAS number 364782-34-3
    D.3.9.2Current sponsor codeAMG 073
    D.3.9.3Other descriptive nameCINACALCET HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB20068
    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 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
    Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis
    Hiperparatiroidismo secundario e insuficiencia renal crónica (IRC) en diálisis.
    E.1.1.1Medical condition in easily understood language
    Secondary Hyperparathyroidism and Chronic Kidney Disease
    Hiperparatiroidismo secundario e insuficiencia renal crónica
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10020708
    E.1.2Term Hyperparathyroidism secondary
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the long-term safety and tolerability of cinacalcet in pediatric subjects with CKD receiving dialysis
    Describir la seguridad y tolerabilidad a largo plazo de cinacalcet en sujetos pediátricos con insuficiencia renal crónica (IRC) sometidos a diálisis.
    E.2.2Secondary objectives of the trial
    To characterize the long-term effect of cinacalcet in pediatric subjects receiving dialysis on laboratory parameters associated with CKD-MBD
    Describir el efecto a largo plazo de cinacalcet en los parámetros analíticos relacionados con las alteraciones minerales y óseas asociadas a la insuficiencia renal crónica (CKD-MBD) en sujetos pediátricos sometidos a diálisis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
    102 Subject must complete treatment through Week 20 in parent study 20130356
    103 Dry weight > 12.5 kg at Day 1
    104 The mean iPTH value (Week19 in 20130356) ≥ 300 pg/mL (Standard of Care arm)
    105 Corrected calcium value (Week 19 in 2010356) ≥ 8.8 mg/dL (Standard of Care arm)
    106 Dialysate calcium concentration ≥ 2.5 mEq/L at day 1
    101 El representante legal autorizado del sujeto ha dado su consentimiento informado cuando el sujeto es demasiado joven legalmente para dar su consentimiento informado y el sujeto ha dado su asentimiento por escrito de acuerdo con las normativas y/o directrices locales antes de iniciar cualquier actividad/procedimiento específico del estudio el día 1.
    102 Tratamiento completado hasta la semana 20 del estudio original 20130356.
    103 Peso seco ≥ 12,5 kg el día 1
    104 Concentración de calcio en el dializado ≥ 2,5 mEq/L el día 1
    Solo los sujetos aleatorizados en el grupo de tratamiento estándar del estudio 20130356
    105 Valor de la PTHi ≥ 300 pg/mL (semana 19 del estudio 20130356)
    106 Valor del calcio corregido ≥ 8,8 mg/dL (semana 19 del estudio 20130356)
    E.4Principal exclusion criteria
    201 Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
    202 Other investigational procedures while participating in this study are excluded.
    203 Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
    204 Subject has known sensitivity to any of the products to be administered during dosing
    205 Subject likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures (eg, electronic patient diary) to the best of the subject and investigator's knowledge
    206 History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    207 Subject previously has entered this study.
    208 If sexually active, subject is not willing to use highly effective contraception during treatment and for at least 9 days after the end of treatment
    209 Subject is pregnant or breast feeding, or planning to become pregnant during the study or within 9 days after the end of treatment
    210 History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrythmias or other conditions associated with prolonged QT interval
    At Day 1 Study Visit
    211 Subject has a clinically significant (in the opinion of the investigator) or severe (grade ≥ 3 CTCAE v 4.0) ongoing adverse event related to IP from Study 20130356
    212 Corrected QT Interval (QTc) > 500 ms, using Bazett's formula
    213 QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
    214 Use of grapefruit juice, herbal medications or CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole) or CYP2D6 substrates (eg,flecainide, propafenone, metoprolol, desipramine, nortriptyline, clomipramine)
    215 Use of concomitant medications that may prolong the corrected QT interval (eg, ondansetron, albuterol)
    At Day 1 Study Visit-Subjects Randomized to the 20130356 Cinacalcet Arm Only
    217 Cinacalcet dose withheld > 1 month
    201 Estar recibiendo actualmente tratamiento en otro estudio de un fármaco o dispositivo en investigación o haber transcurrido menos de 30 días desde el fin del tratamiento en otro estudio de un fármaco o dispositivo en investigación, aparte del estudio 20130356 de Amgen.
    202 Están excluidos otros procedimientos experimentales durante la participación en este estudio.
    203 Tumor maligno, excepto cáncer de piel no melanomatoso o carcinoma cervical o ductal de mama in situ, en los últimos 5 años.
    204 El sujeto presenta una sensibilidad conocida a alguno de los productos que se administrarán durante la dosificación.
    205 Según informan el sujeto y el investigador, es posible que el sujeto no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo y/o cumplir todos los procedimientos del estudio (p. ej., diario electrónico del paciente [diario-e]).
    206 Antecedentes o evidencia de cualquier otro trastorno, condición o enfermedad clínicamente significativo (excepto los indicados anteriormente) que, en opinión del investigador o del médico de Amgen, si se le consulta, pudieran suponer un riesgo para la seguridad del sujeto o interferir en la evaluación, los procedimientos o la realización del estudio.
    207 El sujeto ya ha sido incluido anteriormente en este estudio.
    208 Si el sujeto es sexualmente activo y no está dispuesto a utilizar métodos anticonceptivos altamente eficaces durante el tratamiento y durante al menos 9 días después de finalizar el tratamiento.
    209 Mujer embarazada o en período de lactancia, o que planee quedarse embarazada durante el estudio o en los 9 días posteriores al fin del tratamiento.
    210 Antecedentes de síndrome de QT largo congénito, bloqueo cardíaco de segundo o tercer grado, taquiarritmias ventriculares u otras enfermedades asociadas a un intervalo QT prolongado.
    Visita del día 1 del estudio-Todos los sujetos
    211 El sujeto presenta un acontecimiento adverso en curso del estudio 20130356 que se considera relacionado con el PI y:
    ? Es de grado ≥ 3 según los CTCAE (v 4.0) y/o
    ? En opinión del investigador se considera clínicamente significativo.
    212 Los valores del laboratorio central (Cac, PTHi) no se obtuvieron/no están disponibles en la semana 19 del estudio 20130356.
    213 Intervalo QT corregido (QTc) > 500 ms, utilizando la fórmula de Bazett.
    214 QTc de ≥ 450 a ≤ 500 ms, utilizando la fórmula de Bazett, a no ser que el investigador dé su permiso por escrito para la inclusión tras consultar con un cardiólogo pediátrico.
    215 Uso de zumo de pomelo, fitomedicamentos, inhibidores de CYP3A4 (p. ej., eritromicina, claritromicina, ketoconazol e itraconazol) o sustratos de CYP2D6 (p. ej., flecainida, propafenona, metoprolol, desipramina, nortriptilina, clomipramina).
    216 Uso de medicaciones concomitantes que pueden prolongar el intervalo QTc (p. ej., ondansetrón y albuterol).
    Visita del día 1 del estudio-Solo los sujetos aleatorizados al grupo de cinacalcet en el estudio 20130356
    217 La dosis cinacalcet se suspendió > 1 mes.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is subject incidence of events of interest (EOI; hypocalcemia, convulsions, hypotension, worsening of heart failure, hypersensitivity, ischemic heart disease, QT prolongation/ventricular tachyarrhytmias, fracture, acute pancreatitis, drug-related hepatic disorders, nervous system disorders [excluding seizures], neoplastic events, and infection).
    La variable principal es la incidencia en el sujeto de acontecimientos de interés (EOI); p. ej., hipocalcemia, convulsiones, hipotensión, empeoramiento de la insuficiencia cardíaca, hipersensibilidad, cardiopatía isquémica, prolongación del QT/taquiarritmias ventriculares, fracturas, pancreatitis aguda, trastornos hepáticos relacionados con el fármaco, trastornos del sistema nervioso [excepto las convulsiones], acontecimientos neoplásicos e infección).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Al finalizar el estudio
    E.5.2Secondary end point(s)
    The primary analysis will be based on FAS for all secondary endpoints. Summary statistics will be provided for percent change in PTH, iPTH, from baseline to week 3, week 7, week 11, week 15, week 19, week 23, and week 28 within the study population and each age group by previous treatment group in the parent study and overall. No missing data imputation will be used. Summary statistics will be provided for serum cCa and phosphorus values from baseline to week 3, week 7, week 11, week 15, week 19, week 23, and week 28 within the study population and each age group by previous treatment group in the parent study and overall. No imputation of missing data will be utilized.
    Additional summary statistics to include iPTH, cCa, and P values from the baseline of the parent study over time to end of this study will also be provided for subjects who are treated with cinacalcet in both studies
    El análisis principal se basará en el GAC para todas las variables secundarias. Se proporcionarán estadísticas de resumen para el cambio porcentual en la PTHi desde el día 1 hasta la semana 11 y la semana 28 dentro de la población del estudio y en cada grupo de edad según el grupo de tratamiento previo en el estudio original y en conjunto. No se utilizará la imputación de datos ausentes. Se proporcionarán estadísticas de resumen para los valores de Cac y fósforo séricos del día 1 hasta la semana 11 y la semana 28 dentro de la población del estudio y dentro de cada grupo de edad por grupo de tratamiento previo en el estudio original y en conjunto. No se utilizará la imputación de datos ausentes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At various timepoints throughout the study.
    En varios momentos a lo largo del estudio.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Belgium
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Italy
    Lithuania
    Mexico
    New Zealand
    Poland
    Portugal
    Russian Federation
    Slovakia
    Spain
    Ukraine
    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
    End of Study per protocol is defined as when the last subject is assessed or receives an intervention for the purposes of final collection of data.
    El fin del estudio se define como el momento en que el último sujeto se evalúa o recibe una intervención con la intención de recopilar los últimos datos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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: 48
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 24
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 48
    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)
    There will be a 4-week safety follow-up period for this study.
    Para este estudio habrá un período de seguimiento de seguridad de 4 semanas.
    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 Decision2015-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-15
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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