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    EudraCT Number:2017-001821-42
    Sponsor's Protocol Code Number:CL011_168
    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:2017-10-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-001821-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
    "Estudio de fase II randomizado, doble ciego y controlado con placebo para evaluar la seguridad y eficacia de avacopán (CCX168) en pacientes con glomerulopatía C3"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of a group of related conditions that cause the kidneys to malfunction, called C3 Glomerulopathy.
    Un estudio clínico para evaluar la seguridad y la eficacia de CCX168 (Avacopan), un nuevo fármaco para el tratamiento de un grupo de afecciones relacionadas que causan el mal funcionamiento de los riñones, llamada glomerulopatía C3.
    A.4.1Sponsor's protocol code numberCL011_168
    A.5.4Other Identifiers
    Name:IND NumberNumber:132 321
    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 SponsorChemoCentryx, 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 supportChemoCentryx, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace Spain S.L.
    B.5.2Functional name of contact pointMónia Bermejo
    B.5.3 Address:
    B.5.3.1Street Addressc/ Agustín de Foxá 29, 8ª Planta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28036
    B.5.4Telephone number+3491790056525854
    B.5.5Fax number+34900981853
    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/3/17/1880
    D.3 Description of the IMP
    D.3.1Product nameAvacopan
    D.3.2Product code CCX168
    D.3.4Pharmaceutical form Capsule
    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 INNAVACOPAN
    D.3.9.1CAS number 1346623-17-3
    D.3.9.2Current sponsor codeCCX168
    D.3.9.4EV Substance CodeSUB186880
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD, formerly called membranoproliferative glomerulonephritis [MPGN] Type II) and C3 glomerulonephritis (C3GN, formerly called idiopathic MPGN).
    La GC3 se caracteriza por signos de activación alternativa del complemento basada en el depósito de C3 en los glomérulos. Hay dos formas de la enfermedad: enfermedad por depósitos densos (EDD, anteriormente llamada glomerulonefritis membranoproliferativa [GNMP] de tipo II) y glomerulonefritis C3 (GNC3, anteriormente denominada GNMP idiopática).
    E.1.1.1Medical condition in easily understood language
    C3 glomerulopathy, a group of related conditions that cause the kidneys to malfunction
    Glomerulopatía C3, un grupo de afecciones relacionadas que causan mal funcionamiento de los riñones
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077827
    E.1.2Term C3 glomerulopathy
    E.1.2System Organ Class 10038359 - Renal and urinary 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 is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken before and during treatment.
    El objetivo principal es evaluar la eficacia del avacopán en comparación con placebo basada en los cambios histológicos en biopsias renales realizadas antes y durante el tratamiento.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study include evaluation of:
    1.The safety of avacopan compared to placebo based on the incidence of adverse events, changes in clinical laboratory measurements, and vital signs;
    2.Changes in laboratory parameters of renal disease including estimated glomerular filtration rate (eGFR), proteinuria, and urinary excretion of monocyte chemoattractant protein-1 (MCP-1) with avacopan compared to placebo;
    3.Health-related quality-of-life changes based on Short Form-36 version 2 (SF-36 v2) and EuroQOL-5D-5L (EQ-5D-5L) with avacopan compared to placebo;
    4.The pharmacokinetic profile of avacopan in patients with C3G.
    Additionally, changes from baseline in markers of alternative complement pathway involvement and other markers of inflammation may be assessed in plasma/serum or urine over the course of the treatment period.
    Los objetivos secundarios de este estudio incluyen la evaluación de:
    1. La seguridad del avacopán en comparación con el placebo basada en la incidencia de acontecimientos adversos, las variaciones en los valores analíticos clínicos y las constantes vitales;
    2. Las variaciones en los parámetros analíticos indicativos de nefropatía, incluida la filtración glomerular estimada (FGe), la proteinuria y la excreción urinaria de la proteína quimiotáctica para los monocitos 1 (monocyte chemoattractant protein, MCP-1) con el tratamiento con avacopán en comparación con placebo;
    3. Las variaciones en la calidad de vida relacionada con la salud basada en el Cuestionario abreviado de calidad de vida Short-Form, versión 2 (SF-36 v2) y el cuestionario EuroQOL-5D-5L (EQ-5D-5L) con el tratamiento con avacopán en comparación con placebo;
    4. El perfil farmacocinético del avacopán en pacientes con GC3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, and with the following observations upon renal biopsy taken within 12 weeks prior to screening or during screening:
    a.≥2-levels of magnitude greater staining of C3 than any combination of IgG, IgM, IgA, kappa and lambda light chains, and C1q by immunohistochemistry, and
    b.evidence of proliferative glomerulonephritis (mesangial hypercellularity of greater than 3 mesangial cells per mesangial area and/or endocapillary hypercellularity defined as an increased number of cells within glomerular capillary lumina, causing luminal narrowing) based on light microscopy, and
    c.confirmation of the presence of electron dense deposits in the glomeruli on electron microscopy corresponding with the C3 immunofluorescence positivity;
    2.Plasma soluble C5b-9 level >244 ng/mL, the upper limit of the reference range of the central laboratory;
    3.Male or female subjects, aged at least 18 years; where approved, adolescents (12-17 year old) may be enrolled; female subjects of childbearing potential (i.e., those who have experienced menarche and who is not permanently sterile or postmenopausal, defined as at least 12 consecutive months with no menses without an alternative medical cause) may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the 3 months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year (combined estrogen and progestogen [oral, intravaginal, or transdermal], or progestogen-only hormonal contraception (oral, injectable, or implantable), intra-uterine device, intra-uterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, or true sexual abstinence, i.e., in line with the preferred and usual lifestyle of the subject);
    4.Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; written Assent and Informed Consent must be obtained from the legal guardian in accordance with regional laws or regulations for subjects 12 to 17 years of age; and
    5.Judged to be otherwise fit for the study by the Investigator, based on medical history, physical examination, and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.
    1.GC3 (bien EDD o GNC3) confirmada mediante biopsia, con o sin trasplante renal, y con las siguientes observaciones en la biopsia renal realizada en las 12 semanas previas al screening o durante el screening:
    a. tinción de ≥ 2 niveles de magnitud del C3 mayor que cualquier combinación de IgG, IgM, IgA, cadenas ligeras kappa y lambda, y C1q, mediante inmunohistoquímica; y
    b. signos de glomerulonefritis proliferativa (hipercelularidad mesangial de más de 3 células mesangiales por área mesangial o hipercelularidad endocapilar definida como un aumento del número de células dentro de las luces de los capilares glomerulares, que causan un estrechamiento luminal) basados en microscopia óptica; y
    c.confirmación de depósitos electrodensos en los glomérulos mediante microscopia electrónica correspondiente a la positividad para C3 en la inmunofluorescencia;
    2. Niveles plasmáticos de C5b-9 soluble > 244 ng/ml, el límite superior del intervalo de referencia del laboratorio central;
    3. Varones o mujeres, con una edad mínima de 18 años; cuando sea aprobado, se podrán incluir adolescentes (de 12 a 17 años); las mujeres con capacidad de procrear (es decir, las que hayan alcanzado la menarquía y que no sean estériles ni posmenopáusicas de forma permanente, entendiéndose por «posmenopáusicas» que lleven un mínimo de 12 meses sin menstruar, sin que exista para ello una causa médica alternativa) podrán participar si utilizan métodos anticonceptivos aceptables durante el estudio y, como mínimo, los 3 meses posteriores a su finalización; los pacientes varones con parejas que puedan quedarse embarazadas podrán participar en el estudio si les han hecho una vasectomía como mínimo 6 meses antes de la randomización o si utilizan métodos anticonceptivos aceptables durante el estudio y, como mínimo, los 3 meses posteriores a la finalización del estudio. Se consideran métodos anticonceptivos aceptables aquellos con una tasa de fracaso inferior al 1 % anual (anticonceptivos hormonales combinados de estrógenos y gestágenos [orales, intravaginales o transdérmicos] o solo gestagénicos [orales, inyectables o implantables], dispositivo intrauterino, sistema intrauterino liberador de hormonas, oclusión tubárica bilateral, vasectomía de la pareja o abstinencia sexual real, es decir, en consonancia con el estilo de vida habitual y preferido del sujeto);
    4. Querer y poder dar el consentimiento informado por escrito y cumplir con los requisitos del protocolo del estudio; para los pacientes de 12 a 17 años, debe obtenerse el asentimiento por escrito y también debe obtenerse el consentimiento informado por escrito debe obtenerse del tutor legal conforme a las leyes y reglamentos regionales; y
    5. Estar en buen estado, según el investigador, para participar en el estudio, según la historia médica, la exploración física y las evaluaciones de los análisis clínicos. Podrán participar en el estudio los sujetos con valores en los análisis clínicos que estén fuera de los límites normales (salvo los especificados en los criterios de exclusión) o con otras anomalías clínicas que el investigador consideren que no tienen significación clínica.
    E.4Principal exclusion criteria
    1.Pregnant or nursing;
    2.Tubulointerstitial fibrosis appears to be more than 50% based on standard assessment using trichrome staining of the renal biopsy;
    3.Use of eculizumab or another anti-C5 antibody within 26 weeks prior to dosing;
    4.Secondary C3 disease, e.g., infection-associated disease, or associated with another systemic or autoimmune disease; presence of a monoclonal spike on serum or urine protein electrophoresis or immunofixation assay;
    5.Currently on dialysis or likely will require dialysis within 7 days after screening;
    6.History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis;
    7.Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral screening test indicative of acute or chronic infection;
    8.Evidence of tuberculosis based on interferon γ release assay (IGRA), tuberculin purified protein derivative (PPD) skin test, or chest radiography done at screening or within 6 weeks prior to screening;
    9. Active uncontrolled Infection
    10.WBC count less than 3500/μL, or neutrophil count less than 1500/μL, or lymphocyte count less than 500/μL before start of dosing;
    11.Evidence of hepatic disease; AST, ALT, alkaline phosphatase, or bilirubin >3 x the upper limit of normal before start of dosing;
    12.Currently using a strong inducer of the CYP3A4 enzyme, such as carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's wort;
    13.Known hypersensitivity to avacopan or inactive ingredients of the avacopan capsules (including gelatin, polyethylene glycol, or Cremophor) or inability to swallow the capsules;
    14.Participated in any clinical study of an investigational product within 30 days prior to screening or within 5 half-lives after taking the last dose; and
    15.History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
    1. Embarazo o lactancia;
    2. La fibrosis tubulointersticial para estar basada en más de un 50 % en la evaluación habitual usando tinción tricrómica de la biopsia renal;
    3. Uso de eculizumab u otro anticuerpos anti-C5 en las 26 semanas previas a la administración;
    4. Enfermedad secundaria del C3, p. ej., enfermedad asociada a infección, o asociada a otra enfermedad sistémica o autoinmunitaria; presencia de un componente monoclonal en un ensayo de inmunofijación o de electrofóresis de proteínas en suero u orina;
    5. Sujeto actualmente en diálisis o que probablemente necesitará diálisis en un plazo de 7 días después del screening;
    6. Antecedentes o presencia de cualquier forma de cáncer en los 5 años previos al screening, con la excepción de carcinoma cutáneo basocelular o espinocelular extirpado, o carcinoma localizado como carcinoma de cuello uterino o de mama preinvasor que se haya extirpado o resecado por completo y no haya signos de recidiva locorregional ni de metástasis;
    7. Positividad en las pruebas de detección del VHB, VHC o VIH, indicativa de infección aguda o crónica;
    8. Signos de tuberculosis según la prueba de liberación de interferón γ (IGRA), la prueba de intradermorreacción de Mantoux (con derivado proteínico purificado, DPP) o una radiografía de tórax realizadas en el screening o en las 6 semanas anteriores;
    9.Infección activa no controlada;
    10.Número de leucocitos menor de 3500/μl o recuento de neutrófilos inferior a 1500/μl o número de linfocitos menor de 500/μl antes del inicio de la administración;
    11.Signos de hepatopatía: AST, ALT, fosfatasa alcalina o bilirrubina > 3 veces el límite superior de la normalidad antes del inicio de la administración;
    12.En tratamiento actualmente con un inductor potente de la isoenzima 3A4 del citocromo P450 (CYP3A4), como carbamazepina, fenobarbital, fenitoína, rifampicina o hipérico (hierba de San Juan);
    13.Hipersensibilidad conocida al avacopán o los componentes inactivos de las cápsulas del avacopán (incluidos gelatina, polietilenglicol o Cremophor) o imposibilidad de tragar las cápsulas;
    14.Participación en otro ensayo clínico con un producto en fase de investigación en el plazo de 30 días antes del screening, o cinco semividas después de haber recibido la última dosis; y
    15.Antecedentes o presencia de cualquier enfermedad o circunstancia médica que, en opinión del investigador, pueda poner al sujeto en una situación de riesgo inaceptable si participa en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The percent change from baseline to Week 26 in the C3G Histologic Index for disease activity
    El criterio principal de valoración es la variación porcentual desde el periodo basal hasta la semana 26 en el índice histológico de la GC3 para la actividad de la enfermedad
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    Semana 26
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include:
    1.The proportion of subjects who have a histologic response, defined as a decrease (improvement) in the C3G Histologic Index for activity of at least 35% from baseline to Week 26 (see Section 8.7 for basis of selection of 35% threshold);
    2.The percent change from baseline in the C3G Histologic Index for disease chronicity over the placebo-controlled 26-week treatment period;
    3.The change and percent change from baseline in eGFR over the placebo-controlled 26-week treatment period;
    4.The percent change from baseline in UPCR over the placebo-controlled 26-week treatment period;
    5.The percent change from baseline in urinary MCP-1:creatinine ratio over the placebo-controlled 26-week treatment period;
    6.Change from baseline in EQ-5D-5L (visual analogue scale and index) and SF-36 v2 (domains and component scores) over the placebo-controlled 26-week treatment period.

    Safety endpoints include:
    1. Subject incidence of treatment-emergent serious adverse events, adverse events, and withdrawals due to adverse events;
    2. Change from baseline and shifts from baseline in all safety laboratory parameters;
    3. Change from baseline in vital signs.

    PK endpoints
    Avacopan (and metabolite) plasma concentration results will be used to calculate trough plasma concentrations (Cmin) over the course of the clinical trial. If sufficient data are available, population PK analyses may also be performed to determine PK parameters for avacopan and significant metabolites.
    The Cmax, Tmax, and AUC0-6hr will be determined for subjects 12 to 17 years old based on avacopan and metabolite plasma concentration data on Day 1.

    PD endpoints
    The following PD endpoints may be assessed:
    1.Change and percent change from baseline in plasma biomarkers such as inflammatory chemokine and cytokine levels.
    2.Change and percent change from baseline in urine biomarkers such as urinary sCD163:creatinine ratio, inflammatory chemokine and cytokine levels;
    3.Change from baseline in CBC count (especially WBCs, neutrophils, and lymphocytes) and lymphocyte subset counts including B cells, T cells, and natural killer cells;
    Los criterios de valoración de la eficacia incluyen:
    1.El porcentaje de sujetos que tengan una respuesta histológica, definida como una disminución (mejoría) en el índice histológico de la GC3 para la actividad de al menos el 35 % desde el periodo basal hasta la semana 26;
    2.La variación porcentual respecto al periodo basal en el índice histológico de la GC3 para la cronicidad de la enfermedad durante el periodo de tratamiento de 26 semanas controlado con placebo;
    3.La variación y la variación porcentual respecto al periodo basal en la FGe durante el periodo de tratamiento de 26 semanas controlado con placebo;
    4.La variación porcentual respecto al periodo basal en el CPCO durante el periodo de tratamiento de 26 semanas controlado con placebo;
    5.La variación porcentual respecto al periodo basal en el cociente MCP-1:creatinina en orina durante el periodo de tratamiento de 26 semanas controlado con placebo;
    6.La variación respecto al periodo basal en los cuestionarios EQ-5D-5L (escala visual analógica e índice) y SF-36 v2 (puntuaciones de los dominios y componentes) durante el periodo de tratamiento de 26 semanas controlado con placebo.
    Los criterios de valoración de la seguridad incluyen:
    1.Incidencia en los sujetos de acontecimientos adversos graves aparecidos durante el tratamiento, acontecimientos adversos y retiradas ocasionadas por acontecimientos adversos;
    2.Variación respecto al periodo basal y fluctuaciones respecto al periodo basal en todos los parámetros analíticos de seguridad;
    3.Variación respecto al periodo basal en las constantes vitales.
    Criterios de Valoración FC
    Los resultados de la concentración plasmática de Avacopan (y metabolito) se utilizarán para calcular las concentraciones plasmáticas mínimas (Cmin) durante el curso del ensayo clínico. Si se dispone de datos suficientes, también se pueden realizar análisis de PK de población para determinar parámetros de PK para avacopan y metabolitos significativos.
    La Cmax, Tmax y AUC0-6hr se determinarán para los sujetos de 12 a 17 años de edad basados en avacopan y los datos de la concentración plasmática del metabolito en el Día 1.
    Criterios de Valoración FD
    Pueden evaluarse los siguientes resultados de PD:
    1.Cambio y cambio porcentual desde la línea de base en biomarcadores plasmáticos como los niveles de quimiocinas inflamatorias y citocinas.
    2.Cambio y cambio porcentual desde la línea de base en los biomarcadores de orina, como la relación sCD163: creatinina urinaria, quimioquinas inflamatorias y niveles de citoquinas;
    3. Cambiar de la línea base en el recuento de CBC (especialmente los glóbulos blancos, los neutrófilos y los linfocitos) y los recuentos de subconjuntos de linfocitos incluyendo células B, células T y células asesinas naturales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 26
    Semana 26
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    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
    Última Visita del Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 4
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 44
    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 - expected normal treatment of that condition
    ninguno - tratamiento normal esperado de esa afección
    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 Decision2017-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-27
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