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    Summary
    EudraCT Number:2014-005555-80
    Sponsor's Protocol Code Number:V00400SB302
    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 number2014-005555-80
    A.3Full title of the trial
    Efficacy and safety of Hemangiol solution in the treatment of high risk infantile hemangioma. A Multinational Single Arm Study
    Eficacia y seguridad de la solución Hemangiol en el tratamiento del hemangioma infantil de alto riesgo. Estudio multinacional con un solo grupo de tratamiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of Hemangiol solution in the treatment of high risk infantile hemangioma. A Multinational Single Arm Study
    Eficacia y seguridad de la solución Hemangiol en el tratamiento del hemangioma infantil de alto riesgo. Estudio multinacional con un solo grupo de tratamiento.
    A.4.1Sponsor's protocol code numberV00400SB302
    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 SponsorPierre Fabre Dermatologie represented by IRPF
    B.1.3.4CountryFrance
    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 supportPierre Fabre Dermatologie
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address3 avenue Hubert Curien - BP13562
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number34931850200
    B.5.5Fax number34931850257
    B.5.6E-mailcontact_essais_cliniques@pierre-fabre.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 HEMANGIOL
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Dermatologie
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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.3.4Pharmaceutical form Oral solution
    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 INNPROPRANOLOL HYDROCHLORIDE
    D.3.9.1CAS number 318-98-9
    D.3.9.2Current sponsor codeV0400SB
    D.3.9.3Other descriptive name(2RS)-1-[(1-methylethyl)amino]-3-(naphthalen-1-yloxy)propan-2-ol hydrochloride
    D.3.9.4EV Substance CodeSUB04091MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.28
    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 Yes
    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
    High risk infantile haemangioma
    Hemangioma infantil de alto riesgo
    E.1.1.1Medical condition in easily understood language
    Haemangioma of the child
    Hemangioma infantil
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10018814
    E.1.2Term Haemangioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To document the efficacy of Hemangiol administered during at least 6 months and up to a maximum of 12 months of age in infants with high risk IH.
    Documentar la eficacia de Hemangiol administrado durante al menos 6 meses y como máximo hasta los 12 meses de edad en bebés con HI de alto riesgo.
    E.2.2Secondary objectives of the trial
    To document
    - the safety of Hemangiol.
    - the persistence of IH response up to 3 months after treatment interruption.
    - the efficacy of Hemangiol re-administered during up to 6 months in case of hemangioma relapse based on investigator?s judgment.
    - the impact of Hemangiol on family burden and quality of life linked to the IH.
    Documentar
    -La seguridad de Hemangiol.
    -La persistencia de la respuesta del HI hasta 3 meses después de la interrupción del tratamiento.
    -La eficacia de Hemangiol tras su administración durante un máximo de 6 meses en caso de recidiva del hemangioma, según el criterio del investigador.
    -El impacto de Hemangiol en la carga familiar y la calidad de vida relacionada con el HI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 35-150 days old inclusive, also subject born prematurely but of his/her term equivalent age at inclusion (corrected age)
    2. High risk IH in proliferative phase (target hemangioma):
    - life-threatening IH
    - peri-orbital, nasal, labial, laryngo-tracheal, limb joints IHs with functional impact or at risk of functional impact
    - disfiguring IH (IH > 5cm, glabella location, nasal location, philtrum location, central chin location, central cheek location, labial IH with mouth deformities)
    - ulcerated IH not responding to simple wound care measures, located anywhere on the body
    3. If required by national regulations, registered with a social security or health insurance system and/or whose parent(s) or legal guardian(s) was (were) registered with a social security or health insurance system
    4. Written informed consent(s) for study participation and the use of the subject?s images obtained according to national regulations from the subject?s parent(s) or guardian(s) prior to performing any study procedures
    1.Edad del paciente comprendida entre los 35 y 150 días, ambos inclusive, en el momento de inclusión, así como bebés prematuros con una edad equivalente en el momento de la inclusión (edad corregida).
    2.HI de alto riesgo en fase proliferativa (hemangioma diana):
    -HI potencialmente mortal.
    -HI periorbitario, nasal, labial, laringotraqueal o en articulaciones de las extremidades con impacto funcional o en riesgo de impacto funcional.
    -HI desfigurante (HI > 5 cm, localización en entrecejo, nasal, surco nasolabial, mentón central, mejilla central, HI labial con deformidades bucales).
    -HI ulcerado que no responde a medidas sencillas de tratamiento de las heridas, en cualquier localización del cuerpo.
    3.Si lo requieren las normativas nacionales, inscritos en un sistema de seguridad social o un seguro médico y/o con padres o tutores legales inscritos en un sistema de seguridad social o seguro médico.
    4.Obtención del consentimiento informado por escrito de los padres o el tutor del paciente para participar en el estudio y para poder emplear las imágenes del paciente con arreglo a las normativas nacionales, antes de realizar ningún procedimiento del estudio.
    E.4Principal exclusion criteria
    5. Medically unstable health status that may interfere with his/her ability to complete the study, especially acute broncho-pulmonary abnormality
    6. Presence of one or more of the following medical conditions:
    - Congenital hemangioma
    - Kasabach-Merritt syndrome
    - PHACE syndrome
    - Hepatic hemangioma
    - Asthma
    - History of bronchospasm
    - At risk of hypoglycaemia according to the medical file of the subject
    - Phaeochromocytoma
    - Hypotension (SBP/DBP <65/45 mmHg for age 35-90 days, < 70/50 mmHg for age 91-150 days)
    - Second or third degree heart block
    - Cardiogenic shock
    - Bradycardia (HR < 100 bpm for age 35-90 days, < 90 bpm for age 91-150 days)
    - Severe peripheral arterial circulatory disturbances, Raynaud?s phenomenon
    - Disease of the sinus node (including sinoatrial block)
    - Uncontrolled heart failure
    - Prinzmetal?s angina
    - Hepatic and/or renal impairment
    - Psoriasis
    7. Kaliemia > 5.0 mmol/L (only measured for subjects presenting an IH with ulcerated area >= 3 cm)
    8. Subject?s target hemangioma treated by LASER therapy within the past month,
    9. The subject (and/or the mother if she is breastfeeding the subject) has received at least one of the following prohibited medications within 14 days before first study drug administration:
    - Corticosteroids by systemic (oral, intra-venous or intra-muscular), intra-lesional or topical route
    - Imiquimod
    - Vincristine
    - Alfa-interferon
    - Propranolol or other beta-blockers
    - Cardiovascular treatments:
    . bradycardia-inducing calcium channel blockers (diltiazem, verapamil, bepridil),
    . anti-arrhythmics (propafenone, quinidine, amiodarone, lidocaine),
    . inotropic agents (digitalis glycosides),
    . dihydropyridines (amlodipine, felodipine, isradipine, lacidipine, lercanidipine, manidipine, nicardipine, nifedipine, nitrendipine, etc?),
    . antihypertensives (ACE Inhibitors, angiotensin II-receptors antagonists, diuretics, alpha-blockers whatever the indication, centrally-acting antihypertensives, reserpine, etc?)
    - Drugs inducing orthostatic hypotension (nitrates derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen, etc?)
    - Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose
    - Enzyme inducers (rifampicin, phenobarbital,?)
    - Hypoglycaemic agents or drugs able to induce hypoglycaemia
    - Lipid lowering agents (cholestyramine, colestipol)
    - Halogenated anesthetic agents, lidocaine (exclusion period shortened to 48 hours if anaesthesia has been performed for diagnosis investigation, e.g. MRI?)
    10. Hypersensitivity to any study drug ingredient
    11. Hypersensitivity any beta-blocker
    12. Medical history of anaphylactic reaction
    5.El paciente tiene un estado de salud médicamente inestable que podría interferir en su capacidad de finalizar el estudio, especialmente anomalía broncopulmonar aguda.
    6.Presencia de una o más de las siguientes afecciones:
    -Hemangioma congénito
    -Síndrome de Kasabach-Merritt
    -Síndrome PHACE
    -Hemangioma hepático
    -Asma
    -Antecedentes de broncoespasmo
    -En riesgo de hipoglucemia de acuerdo con la historia clínica del paciente
    -Feocromocitoma
    -Hipotensión (PAS/PAD < 65/45 mm Hg en los pacientes con una edad de 35 a 90 días, < 70/50 mm Hg en los pacientes con una edad de 91 a 150 días)
    -Bloqueo cardíaco de segundo o tercer grado
    -Choque cardiógeno
    -Bradicardia (FC < 100 lpm en los pacientes con una edad de 35 a 90 días, < 90 lpm en los pacientes con una edad de 91 a 150 días)
    -Trastornos circulatorios arteriales periféricos graves, fenómeno de Raynaud
    -Enfermedad del nódulo sinusal (incluido bloqueo sinoauricular)
    -Insuficiencia cardíaca no controlada
    -Angina de Prinzmetal
    -Insuficiencia hepática y/o renal
    -Psoriasis
    7.Potasemia > 5,0 mmol/l (solo determinada en los pacientes que presenten un HI con un diámetro máximo de la zona ulcerada >=3 cm).
    8.Hemangioma diana del paciente tratado con tratamiento láser en el mes anterior.
    9.El paciente (y/o la madre si está amamantando al paciente) ha recibido al menos uno de los medicamentos prohibidos siguientes en los 14 días anteriores a la primera administración del fármaco del estudio:
    -Corticosteroides sistémicos (orales, intravenosos o intramusculares) intralesionales o tópicos
    -Imiquimod
    -Vincristina
    -Interferón ?
    -Propranolol u otros betabloqueantes
    -Tratamientos cardiovasculares:
    -Antagonistas del calcio que inducen bradicardia (diltiazem, verapamilo, bepridil, etc.)
    -Antiarrítmicos (propafenona, quinidina, amiodarona, lidocaína)
    -Agentes inotrópicos (glucósidos digitálicos)
    -Dihidropiridinas (amlodipino, felodipino, isradipino, lacidipino, lercanidipino, manidipino, nicardipino, nifedipino, nitrendipino, etc.)
    -Antihipertensores (inhibidores de la ECA, antagonistas de los receptores de la angiotensina II, diuréticos, bloqueantes alfa para cualquier indicación, antihipertensores de acción central, reserpina, etc.)
    -Fármacos que inducen hipotensión ortostática (derivados de nitratos, inhibidores de la fosfodiesterasa 5, antidepresivos tricíclicos, antipsicóticos, agonistas dopaminérgicos, levodopa, amifostina, baclofeno, etc.)
    -Fármacos antiinflamatorios no esteroideos (AINE) en dosis antiinflamatorias
    -Inductores enzimáticos (rifampicina, fenobarbital, etc.)
    -Agentes hipoglucemiantes o fármacos que puedan inducir la hipoglucemia
    -Hipolipemiantes (colestiramina, colestipol)
    -Anestésicos halogenados, lidocaína (el periodo de exclusión se acorta a 48 horas si se ha administrado anestesia con fines de investigación diagnóstica, p. ej., RM, etc.)
    10.Hipersensibilidad a cualquier fármaco del estudio.
    11.Hipersensibilidad a cualquier betabloqueante.
    12.Antecedentes médicos de reacción anafiláctica.
    E.5 End points
    E.5.1Primary end point(s)
    Success, defined by investigator, at the end of initial treatment period.
    A subject
    - who is prematurely withdrawn for inefficacy or safety reason with a related AE leading to definitive study drug discontinuation (before the end of initial treatment period),
    - and/or
    - receiving (before the end of initial treatment period), prohibited treatments used to treat target IH (systemic [oral, intra-venous or intra-muscular], intra-lesional or topical corticosteroids, imiquimod, vincristine, alfa-interferon, beta-blockers other than the study treatment), in usual conditions for treating IH with appropriate formulation, dose and treatment duration,
    will be considered for statistical analysis as treatment failure, whatever the evaluation of investigator.

    Analyses of primary outcome measure:
    - Primary analysis: number, percentage and 95% CI of success on the FAS.
    - Supportive analysis: same analysis on the PP set.
    Éxito, definido por investigador, al final del periodo de tratamiento inicial.
    Un paciente:
    -al que se retire de forma prematura por falta de eficacia o por motivos de seguridad con un AA relacionado que da lugar a la suspensión definitiva del fármaco del estudio (antes del final del periodo de tratamiento inicial),
    -y/o
    -que reciba (antes del final de periodo de tratamiento inicial) alguno de los tratamientos prohibidos para tratar el HI diana (corticosteroides sistémicos [orales, intravenosos o intramusculares], intralesionales o tópicos, imiquimod, vincristina, interferón ?, betabloqueantes diferentes del tratamiento del estudio), en condiciones habituales para el tratamiento del HI, con una formulación, dosis y duración del tratamiento adecuadas,
    será considerado para el análisis estadístico como un paciente con fracaso terapéutico, independientemente de la evaluación del investigador.

    Análisis del criterio principal de valoración:
    -Análisis principal: número, porcentaje e IC del 95 % de éxito en el GCA.
    -Análisis complementario: mismo análisis en la población PP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the initial treatment period: 6 months minimum to 11 months maximum
    Periodo de tratamiento inicial: mínimo de 6 meses y máximo de 11 meses
    E.5.2Secondary end point(s)
    All analyses on the secondary outcome measures will be performed on the FAS.
    - Success at each visit (defined in the same way than the primary outcome measure):
    . On the initial treatment period, number (% and 95% CI) of success at each visit
    . Persistence of effect: on the Follow-Up period, number (% and 95% CI) of success on the subset of FAS who are in success at the end of initial treatment period.
    . On the period of re-initiation of treatment, number (% and 95% CI) of success on the subset of FAS who needed to be re-treated.
    - Time to first sustained success from D0 up to the end of study
    Kaplan-Meier cumulative incidence estimates were provided at each time-point where the success assessment was scheduled for two subsets of FAS:
    . Subset of patient in FAS with only the initial treatment period.
    . Subset of patient in FAS with the initial treatment and re-initiation period.
    - Three-point evolution (improvement/stabilization/worsening) of the target IH compared to baseline evaluation:
    . On the initial treatment period, qualitative description at each visit
    . On the Follow-Up period, qualitative description on the subset of FAS who are in improvement at the end of initial treatment period.
    . On the period of re-initiation of treatment, qualitative description on the subset of FAS who needed to be re-treated.
    - Time to first sustained improvement (compared to the previous visit) from D0 up to the end of study:
    .same analyses performed on the time to first sustained success.
    - Time to first sustained improvement (compared to the baseline) from D0 up to the end of study
    . same analyses performed on the time to first sustained success.
    - Re-initiation of treatment:
    . number (%) of patients needed to be re-treated on the subset of FAS who are in success at the end of initial treatment period.
    - Investigator?s qualitative assessment of IH characteristics:
    . description by visit.
    - Functional impact of target IH:
    . graphics plotting evolution by functional impact and by patient.

    Safety analysis:
    The safety analysis will be performed on the FAS.
    - Adverse events (AE):
    . Descriptive statistics according to the status of AE (Emergent or Non-emergent)
    - Height, Weight:
    . Descriptive statistics by visit
    - Vital Signs (Blood pressure and heart rate):
    . Descriptive statistics by visit
    . Descriptive analysis relative to normal ranges

    Quality of life
    The quality of life will be performed on the FAS.
    - Haemangioma Family Burden (HFB) questionnaire:
    For the 5 dimension scores (Family life, Relationship and Work, Emotions/Feelings, Psychological and Disease management) and the HFB total score: Descriptive statistics by visit.
    - SF-36 questionnaire:
    For the 8 dimension scores (physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems, mental health) and for the two summary measures of physical and mental health: Descriptive statistics by visit.
    Todos los análisis de los criterios secundarios de valoración se realizarán en el GCA.
    -Éxito en cada visita (definido de la misma forma que en el criterio principal de valoración):
    ·En el periodo de tratamiento inicial, número (porcentaje e IC del 95 %) de éxito en cada visita.
    ·Persistencia del efecto: en el periodo de seguimiento, número (porcentaje e IC del 95 %) de éxito en el subgrupo del GCA que presente éxito al final del periodo de tratamiento inicial.
    ·En el periodo de reinicio del tratamiento, número (porcentaje e IC del 95 %) de éxito en el subgrupo del GCA que haya necesitado repetición del tratamiento.
    -Tiempo hasta la primera aparición de éxito mantenido desde el D0 hasta el final del estudio
    Se proporcionarán estimaciones de la incidencia acumulada según el método de Kaplan-Meier en cada momento en el que esté programada la evaluación del éxito en dos subgrupos del GCA:
    ·Subgrupo de pacientes del GCA con solo el periodo de tratamiento inicial.
    ·Subgrupo de pacientes del GCA con el tratamiento inicial y el periodo de reinicio del tratamiento.
    -Evolución de tres puntos (mejoría/estabilización/empeoramiento) del HI diana en comparación con la evaluación basal:
    ·En el periodo de tratamiento inicial, descripción cualitativa en cada visita.
    ·En el periodo de seguimiento, descripción cualitativa en el subgrupo del GCA que presente mejoría al final del periodo de tratamiento inicial.
    ·En el periodo de reinicio del tratamiento, descripción cualitativa en el subgrupo del GCA que haya necesitado repetición del tratamiento.
    -Tiempo hasta la primera mejoría mantenida (en comparación con la visita anterior) desde el D0 hasta el final del estudio:
    ·Los mismos análisis realizados sobre el tiempo hasta la primera aparición de éxito mantenido.
    -Tiempo hasta la primera mejoría mantenida (en comparación con el periodo basal) desde el D0 hasta el final del estudio:
    ·Los mismos análisis realizados sobre el tiempo hasta la primera aparición de éxito mantenido.
    -Reinicio del tratamiento:
    ·Número (%) de pacientes que hayan necesitado la repetición del tratamiento en el subgrupo del GCA que presente éxito al final del periodo de tratamiento inicial.
    -Evaluación cualitativa de las características del HI por parte del investigador:
    ·Descripción por visita.
    -Impacto funcional del HI diana:
    ·Gráficos de evolución por impacto funcional y por paciente.

    Análisis de la seguridad:
    El análisis de seguridad se realizará en el GCA.
    -Acontecimientos adversos (AA):
    ·Estadísticos descriptivos conforme al estado de AA (aparecidos o no durante el tratamiento).
    -Estatura, peso:
    ·Estadísticos descriptivos por visita.
    -Constantes vitales (presión arterial y frecuencia cardíaca):
    ·Estadísticos descriptivos por visita.
    ·Análisis descriptivo relativo a los intervalos de normalidad.

    Calidad de vida
    La calidad de vida se analizará en el GCA.
    -Cuestionario sobre la carga familiar del hemangioma (HFB):
    Para las puntuaciones de las 5 dimensiones (vida familiar, relaciones y trabajo, emociones/sentimientos, tratamiento psicológico y de la enfermedad) y la puntuación total del HFB: Estadísticos descriptivos por visita.
    -Cuestionario SF-36:
    Para las puntuaciones de las 8 dimensiones (función física, limitaciones de la función por problemas físicos, dolor corporal, percepción de la salud general, energía/vitalidad, función social, limitaciones de la función por problemas emocionales y salud mental) y para las dos puntuaciones de resumen de la salud física y mental: Estadísticos descriptivos por visita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending of the secondary endpoint as defined above:
    - at each visit
    or
    - at end of first study treatment
    or
    - at time to first sustained success
    En función del criterio secundario de valoración, tal como se define a continuación:
    - en cada visita
    o
    -al final del tratamiento incial
    o
    -en la primera aparición de éxito mantenido
    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 Yes
    E.6.13.1Other scope of the trial description
    Impact on the family burden and quality of life
    Impacto en la carga familiar y la calidad de vida
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Last Patient Last Visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 45
    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: 45
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants - Consent given by parents or guardians.
    Bebés - Consentimiento Informado otorgado por los padres o tutor
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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 sponsor will not supply product to subjects after the end of the study, since a subject may end the study for the following two reasons:
    - Success of treatment, that should not lead to any pursue of the treatment
    - Treatment failure.
    El promotor no suministrará el producto a los sujetos tras el final del estudio, ya que el sujeto abandona el estudio por una de las siguientes razones:
    - Éxito del tratamiento, lo que daría lugar a la finalización del mismo
    - Fallo de tratamiento
    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 Decision2015-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-21
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