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    Summary
    EudraCT Number:2018-002135-19
    Sponsor's Protocol Code Number:0164
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-04-12
    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 number2018-002135-19
    A.3Full title of the trial
    A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC)
    Estudio multicéntrico de seguridad a largo plazo (LTS) de 3 años para evaluar la seguridad y tolerabilidad de TD−1473 en pacientes con colitis ulcerosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC)
    Ensayo Clínico para investigar la Eficacia y Seguridad de TD-1473 para el Tratamiento de la Colitis Ulcerosa (CU)
    A.3.2Name or abbreviated title of the trial where available
    TD-1473 LTS UC Study
    Estudio LTS TD-1473 CU
    A.4.1Sponsor's protocol code number0164
    A.5.4Other Identifiers
    Name:US INDNumber:128299
    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 SponsorTheravance Biopharma Ireland Limited
    B.1.3.4CountryIreland
    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 supportTheravance Biopharma Ireland Limited
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheravance Biopharma Ireland Limited
    B.5.2Functional name of contact pointClinical Operations - CC
    B.5.3 Address:
    B.5.3.1Street AddressConnaught House 1 Burlington Road
    B.5.3.2Town/ cityDublin 4
    B.5.3.3Post codeD04 C5Y6
    B.5.3.4CountryIreland
    B.5.4Telephone number35315532500
    B.5.5Fax number35315532501
    B.5.6E-mailIBDstudies@theravance.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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    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.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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 nameTD-1473
    D.3.2Product code TD-1473
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.2Current sponsor codeTD-1473
    D.3.9.3Other descriptive nameTHRX-139060
    D.3.9.4EV Substance CodeSUB192730
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Moderately-to-severely active Ulcerative Colitis (UC)
    Colitis Ulcerosa (CU) Activa de Moderada a Severa.
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis (UC)
    Colitis Ulcerosa (CU)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of TD-1473 administered up to 3 years in subjects with moderate to severe UC after participation in the Maintenance Study of Protocol 0157.
    Evaluar la seguridad y tolerabilidad de TD-1473 administrado durante un máximo de 3 años en pacientes con CU de actividad moderada a intensa tras la participación en el estudio de mantenimiento del protocolo 0157
    E.2.2Secondary objectives of the trial
    • To assess clinical remission and response rates over time
    • To assess endoscopic healing rates over time
    • To assess clinical remission and response in subjects entering the study after experiencing persistent loss of response or recurrent clinical flare after initial loss of response during the Maintenance Study (Protocol 0157)
    • To assess clinical remission and response in subjects entering the study after completing the Maintenance Study (Protocol 0157)
    • To determine the effect of long-term TD-1473 treatment on major inflammatory bowel disease (IBD)-related events (eg, hospitalizations, surgeries, and procedures)
    • To examine the effect of long-term TD-1473 treatment on health-related quality of life (QOL)
    • Evaluar la remisión clínica y las tasas de respuesta a lo largo del tiempo.
    • Evaluar las tasas de curación endoscópica a lo largo del tiempo.
    • Evaluar la remisión clínica y la respuesta en los pacientes que entren en el estudio tras experimentar una pérdida de respuesta persistente o exacerbación clínica recurrente tras la pérdida de respuesta durante el Estudio de Mantenimiento (Protocolo 0157)
    • Evaluar la remisión clínica y la respuesta en los pacientes que entren en el estudio tras completar el Estudio de Mantenimiento (Protocolo 0157)
    • Evaluar las tasas a largo plazo de acontecimientos significativos relacionados con la enfermedad inflamatoria intestinal (EII) como hospitalizaciones, cirugías y procedimientos en pacientes tratados con TD-1473.
    • Evaluar la calidad de vida (CdV) relacionada con la salud en los pacientes en tratamiento a largo plazo con TD-1473.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of providing informed consent, which must be obtained prior to any study-related procedures.
    2. One of the following:
    a. Those who demonstrated persistent loss of response (no improvement 8 weeks after meeting loss of response criteria) or
    b. two Clinical Flares after an episode of loss of response during the Maintenance Study. Loss of response must be documented by sigmoidoscopy/colonoscopy for the subject to be eligible. Subjects who declined the Clinical Flare Assessment #2 or endoscopic examination at the first Clinical Flare Assessment of Maintenance Study 0157 will not be eligible,
    OR
    c. Those who have completed the Maintenance Study and confirmation of clinical remission status results are available
    3. During the study and for 7 days after receiving the last dose of the study drug, females of childbearing potential or men capable of fathering children must agree to use highly effective birth control measures (failure rate <1% when used consistently and correctly) or agree to abstain from sexual intercourse. Females of childbearing potential must test negative for pregnancy at Day 1.
    4. All male subjects must agree to refrain from semen donation during the study and for 7 days after the last dose of study drug.
    5. Must be able and willing to adhere to the study visit schedule and comply with other study requirements.
    1. Capacidad para dar el consentimiento informado, que debe obtenerse antes de realizar los procedimientos relacionados con el estudio.
    2. Uno de los siguientes:
    a. Haber demostrado pérdida de respuesta persistente (ausencia de mejoría durante 8 semanas tras cumplir los criterios de pérdida de la respuesta); O
    b. Dos exacerbaciones clínicas tras un episodio de pérdida de respuesta durante el estudio de mantenimiento. Para que el sujeto sea apto, la pérdida de respuesta debe documentarse mediante sigmoidoscopia/colonoscopia. No serán aptos los sujetos que se negaron a realizar la Evaluación de Exacerbaciones Clínicas (CFA) n.º 2 ni la exploración mediante endoscopia en la primera evaluación de exacerbaciones clínicas del estudio de mantenimiento 0157; O
    c. Haber completado el estudio de mantenimiento y disponer de confirmación de unos resultados de remisión clínica.
    3. Durante el estudio y los 7 días posteriores a la última dosis del fármaco del estudio, las mujeres con capacidad de concebir o los hombres capaces de procrear deberán aceptar utilizar métodos anticonceptivos muy efectivos (tasa de fracaso < 1 % cuando se usan de forma continuada y correcta) o aceptar abstenerse de tener relaciones sexuales. Las pacientes con capacidad de concebir deben presentar un resultado negativo en una prueba de embarazo en el día 1 (véase el apartado 4.3).
    4. Todos los pacientes hombres deben aceptar abstenerse de donar semen durante el estudio y los 7 días posteriores a la última dosis del fármaco del estudio.
    5. Tener la capacidad y la voluntad de cumplir con el calendario de visitas del estudio y otros requisitos del estudio.
    E.4Principal exclusion criteria
    1. Has current symptoms or signs suggestive of fulminant colitis, toxic megacolon, intestinal perforation
    2. Has a high risk of requiring surgery for UC or any other type of major surgery (eg, requiring general anesthesia) during the study
    3. Has been diagnosed during Protocol 0157 with Crohn’s disease, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, indeterminate colitis, or the subject has a current or past diagnosis of a fistula or abdominal abscess
    4. Has endoscopic findings during Protocol 0157 of colitis-associated colonic dysplasia; however, subjects with spontaneous (non-colitis-associated) adenomas that have been completely resected are eligible
    5. Taking any prohibited medications of exclusion as listed in the protocol currently or previously during Protocol 0157 Maintenance
    6. Deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety or tolerability of the study drug (eg, developed unstable or uncontrolled and clinically significant condition/disease during Protocol 0157); or is unable or unwilling to comply with the study protocol
    7. Develops hypersensitivity to excipients or contents of the study drug as noted in Protocol 0157.
    8. Participating in or interested in participating in another investigational study (exception Protocol 0157)
    9. Has clinically significant abnormalities in the results of laboratory evaluations at the most recent laboratory evaluation prior to LTS Day 1 visit as determined by the investigator, including:
    • AST, ALT, or alkaline phosphatase ≥ 2x the upper limit of normal (ULN)
    • Total bilirubin > 2x ULN (unless diagnosis of Gilbert’s syndrome)
    • Creatinine clearance as calculated by the Cockcroft-Gault formula < 30 mL/min
    • Total white blood cell count (WBC) < 3 x 10^9/L
    • Absolute neutrophil count < 1.5 x 10^9/L
    • Absolute lymphocyte count < 0.8 x 10^9/L
    • Hemoglobin < 8 g/dL
    • Platelet count < 100 x 10^9/L.
    1. Signos o síntomas actuales indicativos de colitis fulminante, megacolon tóxico o perforación intestinal.
    2. Riesgo alto de necesitar cirugía para la CU o cirugía mayor de otro tipo (p. ej., que requiera anestesia general) durante el estudio.
    3. Diagnóstico durante el protocolo 0157 de enfermedad de Crohn, colitis microscópica, colitis isquémica, colitis por radiación, enfermedad diverticular asociada a colitis, colitis indeterminada; diagnóstico anterior o actual de fístula o absceso abdominal.
    4. Hallazgos endoscópicos durante el protocolo 0157 de displasia colónica asociada a colitis; sin embargo, son aptos los pacientes con adenomas espontáneos (no asociados a colitis) que se hayan resecado completamente.
    5. Haber tomado actualmente o en el pasado cualquier medicamento prohibido que conlleve la exclusión del paciente según lo indicado en el anexo 4 durante el periodo de mantenimiento del protocolo 0157.
    6. Considerado por el investigador como inadecuado para el estudio, o que presenta una afección que podría constituir un factor de confusión o interferir en evaluación de la seguridad o tolerabilidad del fármaco del estudio (p. ej., desarrolla una enfermedad clínicamente significativa inestable o sin controlar durante el protocolo 0157); o incapacidad o reticencia para cumplir el protocolo del estudio.
    7. Desarrollo de hipersensibilidad conocida a los excipientes o ingredientes del fármaco del estudio.
    8. Participación o interés en participar en otro estudio de investigación (salvo el protocolo 0157).
    9. Presencia de anomalías clínicamente significativas en los resultados de las evaluaciones de laboratorio más recientes anteriores a la visita del día 1 del estudio LTS según lo determinado por el investigador, incluyendo:
    • AST, ALT o fosfatasa alcalina ≥2 veces el límite superior de la normalidad (LSN).
    • Bilirrubina total >2 × LSN (salvo diagnóstico de síndrome de Gilbert).
    • Aclaramiento de creatinina, calculado con la fórmula de Cockcroft-Gault, <30 ml/min (anexo 2).
    • Cifra total de leucocitos (LEU) <3 × 109/l;
    • Cifra absoluta de neutrófilos <1,5 × 109/l;
    • Cifra absoluta de linfocitos <0,8 × 109/l;
    • Hemoglobina <8 g/dl; o
    • Cifra de plaquetas <100 × 109/l.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of treatment-emergent adverse events, changes in laboratory safety tests, ECGs, and vital sign measurements.
    Incidencia y gravedad de los acontecimientos adversos surgidos durante el tratamiento, alteraciones en los análisis de laboratorio de seguridad, ECG y parámetros de las constantes vitales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout study duration
    A lo largo de la duración del estudio
    E.5.2Secondary end point(s)
    • Proportion of subjects who achieve clinical remission by various definitions at Week 12 among subjects entering the LTS study from Protocol 0157 Maintenance Study with persistent loss of response or recurrent clinical flare after loss of response
    • Proportion of subjects who achieve clinical response by various definitions at Week 12 among subjects entering the LTS study from Protocol 0157 Maintenance Study with persistent loss of response or recurrent clinical flare after loss of response
    • Time to major IBD-related events (hospitalizations, surgeries, or procedures)
    • Changes from baseline in IBDQ, WPAI-UC, and EuroQual (EQ-5D) scores
    • Proportions of subjects achieving clinical remission as defined by various definitions at scheduled time points.
    • Proportions of subjects maintaining clinical response at scheduled time points by various definitions in subjects who entered the LTS study in clinical response from the Maintenance Study in Protocol 0157
    • Proportion of subjects who enter study in clinical remission and maintain clinical remission by various definitions at scheduled time points
    • Proportion of subjects who enter the study in clinical response and maintain clinical response by various definitions at scheduled time points
    • Changes from baseline in partial, adapted, and total Mayo scores at scheduled time points (both Protocol 0157 Induction and Protocol 0157 Maintenance baseline)
    • Proportion of subjects achieving endoscopic response at scheduled time points
    • Proportion of subjects achieving endoscopic remission at scheduled time points
    • Proporción de pacientes que logran la remisión clínica según definiciones diversas en la semana 12 entre los pacientes que entran al estudio LTS desde el estudio de mantenimiento del protocolo 0157 con pérdida de respuesta persistente o exacerbación clínica recurrente tras la pérdida de respuesta.
    • Proporción de pacientes que logran la respuesta clínica según definiciones diversas en la semana 12 entre los pacientes que entran al estudio LTS desde el estudio de mantenimiento del protocolo 0157 con pérdida de respuesta persistente o exacerbación clínica recurrente tras la pérdida de respuesta.
    • Tiempo hasta la aparición de acontecimientos significativos relacionados con la EII (hospitalizaciones, cirugías o procedimientos).
    • Variación con respecto al valor inicial en las puntuaciones de IBDQ, WPAI-UC y EuroQual (EQ-5D) en puntos temporales programados y en todos los dominios.
    • Proporciones de pacientes que logran la remisión clínica según definiciones diversas en puntos temporales programados.
    • Proporciones de pacientes que mantienen la respuesta clínica en puntos temporales programados según definiciones diversas en los pacientes que entraron al estudio LTS en respuesta clínica desde el estudio de mantenimiento del protocolo 0157.
    • Proporción de pacientes que entran en el estudio en remisión clínica y mantienen la remisión clínica según definiciones diversas en puntos temporales programados.
    • Proporción de pacientes que entran en el estudio en respuesta clínica y mantienen la respuesta clínica según definiciones diversas en puntos temporales programados.
    • Variación con respecto al valor inicial en las puntuaciones parciales, adaptadas y totales en puntos temporales programados (tanto en el estudio de inducción del protocolo 0157 como en el inicio del estudio de mantenimiento del protocolo 0157).
    • Proporción de pacientes que logran la respuesta endoscópica en puntos temporales programados.
    • Proporción de pacientes que logran la remisión endoscópica en puntos temporales programados.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12 and at scheduled time points throughout study duration
    Semana 12 y en puntos programados a lo largo de la duración 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 No
    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 trial3
    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 EEA78
    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
    Bulgaria
    Canada
    Croatia
    France
    Georgia
    Germany
    Greece
    Hungary
    Israel
    Poland
    Portugal
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Taiwan
    Ukraine
    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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 500
    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)
    Standard of Care
    Tratamiento Estándar
    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 Decision2019-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-09-01
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