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    Summary
    EudraCT Number:2018-004318-16
    Sponsor's Protocol Code Number:DAS181-3-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-11-11
    Trial 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 number2018-004318-16
    A.3Full title of the trial
    A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
    Estudio en fase III aleatorizado, controlado con placebo, para examinar la eficacia y la seguridad de DAS181 para el tratamiento de la infección por parainfluenza de las vías respiratorias bajas en sujetos inmunodeprimidos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects
    STOP PIV - DAS181 en fase III en infección de vías respiratorias inferiores por VPI en sujetos inmunodeprimidos
    A.3.2Name or abbreviated title of the trial where available
    STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects
    STOP PIV-DAS181 fase III infección de vías respiratorias inferiores por VPI en sujetos inmunodeprimi
    A.4.1Sponsor's protocol code numberDAS181-3-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03808922
    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 SponsorAnsun Biopharma, 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 supportAnsun Biopharma, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnsun Biopharma, Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address3030 Callan Road
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number858452 2631218
    B.5.5Fax number858452 0133
    B.5.6E-mailDAS181@ansunbiopharma.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.3.2Product code DAS181
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFarbefusp
    D.3.9.2Current sponsor codeDAS181
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects
    Tratamiento de la infección por parainfluenza de las vías respiratorias bajas en sujetos inmunodeprimidos
    E.1.1.1Medical condition in easily understood language
    Parainfluenza virus
    Virus de la parainfluenza
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10033796
    E.1.2Term Parainfluenzae viral infections
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of DAS181 on clinical outcome compared to placebo as measured by percentage of RTRA Responders by Day 28
    Demostrar la eficacia de DAS181 en los resultados clínicos en comparación con placebo, determinada mediante el porcentaje de sujetos que con respuesta RTRA (retorno al aire ambiental) el día 28
    E.2.2Secondary objectives of the trial
    1. To evaluate all-cause mortality rate by Day 28 and 35 in DAS181 compared to placebo
    2. To evaluate percent of patients who RTRA by Day 21 in DAS181 compared to placebo
    3. To evaluate time (in days) to cessation of oxygen support in DAS181 compared to placebo
    4. To evaluate rate of Clinical Stability (CS) by Day 28 in DAS181 compared to placebo
    5. To determine the percent of subjects discharged each week (without mortality and hospice) up to Day 35 in DAS181 compared to placebo
    6. To determine the initial length of stay (without mortality and hospice) in DAS181 compared to placebo
    7. To evaluate total length of stay up to Day 35 in DAS181 compared to placebo
    8. To evaluate PIV-related mortality rate by Day 28 and 35 in DAS181 compared to placebo
    1. Evaluar la tasa de mortalidad por cualquier causa los días 28 y 35 con DAS181 comparado con el placebo
    2. Evaluar el porcentaje de pacientes con respuesta RTRA el día 21 con DAS181 comparado con el placebo
    3. Evaluar el tiempo (en días) hasta la interrupción del oxígeno suplementario con DAS181 comparado con el placebo
    4. Evaluar la tasa de la estabilidad clínica (EC) el día 28 con DAS181 comparado con el placebo
    5. Determinar el porcentaje de sujetos que reciben el alta cada semana (sin mortalidad ni programa de cuidados paliativos) hasta el día 35 con DAS181 comparado con el placebo
    6. Determinar la duración de la hospitalización inicial (sin mortalidad ni programa de cuidados paliativos) con DAS181 comparado con el placebo
    7. Evaluar la duración total de la hospitalización hasta el día 35 con DAS181 comparado con el placebo
    8. Evaluar la tasa de mortalidad relacionada con VPI los días 28 y 35 con DAS181 comparado con el placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Main/Parent Optional Pharmacokinetics Sub-Study Information Sheet
    and Consent Form, version 2.0 dated 21Feb2019.

    2. Pediatric Pharmacokinetic Sub-Study Assent Form (12–17 Years Old) Assent of a Minor to Be in an Investigational Study, version 2.0 dated 21Feb2019.

    Objective is to investigate how the study drug is processed by the body by checking how much of the study drug is in the bloodstream at a particular point in time.
    E.3Principal inclusion criteria
    Subjects must meet the following inclusion criteria at the time of randomization to be eligible for participation in this study:
    1. Males and females ≥12 years of age
    2. SpO2 < 92% on room air while at rest and requires supplemental oxygen ≥2 LPM at the time of randomization. Subjects who also require invasive mechanical ventilation (MV) or non-invasive positive pressure ventilation (CPAP or bi-PAP) are eligible, although ventilator support is not mandatory
    3. Immunocompromised, as defined by one or more of the following:
    - Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past
    - Received a solid organ transplant at any time in the past
    - Treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) at any time in the past
    - Treated with chemotherapy for solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past
    4. Confirmed PIV lower tract disease for subjects within the screening period (3 days prior to randomization) will be defined as PIV detection in one of the following:
    - bronchoalveolar lavage (BAL)
    - lung biopsy
    - upper respiratory viral sample:
    o Tracheal aspirate OR sputum OR nasopharyngeal swab (NPS) OR nasopharyngeal wash
    AND
    o Radiographic finding of a new or worsening pulmonary infiltrate, bronchiolitis, OR pneumonitis that temporally is associated with diagnosis of PIV
    infection on chest x-ray or CT scan.
    PIV diagnosis test will use any of the sample types listed above and will be analyzed at local laboratory using one of the following methods:
    - Respiratory virus panel (RVP),
    - Qualitative/quantitative polymerase chain reaction (PCR) or
    - Direct Fluorescent Antibody (DFA)
    Note: If PIV infection is highly suspected but negative result with DFA, it is recommended to retest for PIV using RVP or PCR.
    5. If female, patient must not be pregnant or nursing, and is either:
    - Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral
    oophorectomy, or hysterectomy; or
    - Of childbearing potential and:
    o Is practicing an effective method of contraception (e.g., oral/parenteral contraceptives or a barrier
    method), or
    o Has a vasectomized partner (at least 6 months postvasectomy
    procedure), or
    o Is currently abstinent from sexual intercourse, AND must have a negative serum (beta-human chorionic gonadotropin) pregnancy test at screening
    Women of childbearing potential must be willing to practice the chosen contraceptive method or remain abstinent during the conduct of the study and for at least 30 days after last dose of study medication.
    Acceptable methods of contraception include:
    o Male or female condom with or without spermicides (a female condom should not be used at the same time as a male condom due to risk of tearing)
    o Female barrier contraception (such as diaphragm, cervical cap, or sponge) with spermicide
    o Continuous use of an intrauterine device for at least 90 days before the first dose of study drug
    o Oral, implanted, injected, or vaginal hormonal contraceptives, if successfully used for at least 60 days before the first dose of study drug.
    Additional contraception requirements may need to be followed according to local regulations and/or requirements.
    6. Non-vasectomized males are required to practice effective birth control methods (e.g., abstinence, use of a condom or use of other barrier device) during the conduct of the study and for at least 30 days after last dose of study medication
    7. Capable of understanding and complying with procedures as outlined in the protocol as judged by the Investigator and able to
    sign informed consent form prior to the initiation of any screening or study-specific procedures. Subjects must have the ability to return to the hospital to comply with required procedures if they are discharged during the study.
    Note: For subjects, including minors and patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the subjects' legal representative (parent, guardian or surrogate) must sign an institutional review board (IRB)/independent ethical committee (IEC)-approved informed consent document prior to the initiation of any screening or study specific procedures. Minor subjects must also sign an IRB/IEC-approved assent form unless not required per local and institution regulations
    1.Varón o mujer ≥12 años de edad
    2.SpO2 < 92 % en aire ambiental en reposo y necesidad de ≥2 lpm de oxígeno suplementario en el momento de la aleatorización Los sujetos que además necesiten ventilación mecánica (VM) invasiva o ventilación no invasiva con presión positiva (CPAP o Bi-PAP) son aptos,aunque no sea obligatorio un respirador
    3.Sujetos inmunodeprimidos,definidos por uno o varios de los puntos siguientes:
    •Sometidos a alotrasplante o autotrasplante de células madre hematopoyéticas (TCMH) en algún momento en el pasado
    •Sometidos a trasplante de órgano sólido en algún momento en el pasado
    •Tratados con quimioterapia para neoplasias malignas hematológicas (ej., leucemia,mieloma,linfoma) en algún momento en el pasado
    •Tratados con quimioterapia para neoplasias malignas de tumores sólidos (ej., cáncer de pulmón,mama o cerebro)en algún momento en el pasado
    4.La enfermedad por VPI de las vías respiratorias inferiores confirmada en los sujetos durante el periodo de selección (3 días antes de la aleatorización)se definirá como detección del VPI en alguno de los siguientes:
    •lavado broncoalveolar (LBA)
    •biopsia de pulmón
    •muestra de virus en vías respiratorias superiores:
    -Aspirado traqueal ó esputo ó hisopo nasofaríngeo (HNF) ó lavado nasofaríngeo
    Y
    -Hallazgo radiológico de infiltrado pulmonar,bronquiolitis ó neumonitis,nueva o que empeora que se asocia temporalmente al diagnóstico de infección por VPI en la radiografía o TAC de tórax.
    En la prueba de diagnóstico de VPI se utilizará alguno de los tipos de muestras enumeradas anteriormente y se analizará en el laboratorio local utilizando uno de los siguientes métodos:
    •Panel de virus respiratorios (PNR),
    •Reacción en cadena de la polimerasa (PCR) cualitativa/cuantitativa o
    •Anticuerpos fluorescentes directos (AFD)
    Nota:si hay elevada sospecha de infección por VPI pero el resultado es negativo con AFD,se recomienda volver a realizar la prueba para VPI con PNR o PCR.
    5.Si es mujer,no deberá estar embarazada ni en periodo de lactancia y,o bien:
    •No está en edad fértil,lo que se define como posmenopáusica durante al menos 1 año o quirúrgicamente estéril debido a ligadura de trompas bilateral,ovariectomía bilateral o histerectomía,o bien
    •Está en edad fértil y:
    -Lleva utilizando un método anticonceptivo eficaz (ej.,anticonceptivos orales/parenterales o un método de barrera),o
    -Tiene una pareja vasectomizada (han transcurrido al menos 6 meses después de someterse a un procedimiento de vasectomía),o
    -Actualmente no mantiene relaciones sexuales Y debe tener un resultado negativo en una prueba de embarazo en suero (gonadotropina coriónica humana beta) en la selección
    Las mujeres en edad fértil deben estar dispuestas a utilizar el método anticonceptivo elegido o practicar la abstinencia sexual durante la realización del estudio y durante al menos 30 días después de la última dosis de la medicación del estudio.
    Son métodos anticonceptivos aceptables:
    -Preservativo masculino o femenino con o sin uso de espermicidas(un preservativo femenino no debe utilizarse al mismo tiempo que un preservativo masculino debido al riesgo de desgarro)
    -Anticonceptivos femeninos de barrera(como el diafragma,el capuchón cervical o la esponja)con espermicida
    -Uso continuo de un dispositivo intrauterino durante al menos 90 días antes de la primera dosis del fármaco del estudio
    -Anticonceptivos hormonales orales, implantados,inyectados o vaginales si se utilizan satisfactoriamente durante al menos 60 días antes de la primera dosis del fármaco del estudio.
    Puede ser necesario cumplir otros requisitos anticonceptivos adicionales conforme a la normativa y/o los requisitos locales.
    6.Los varones no vasectomizados deben utilizar métodos anticonceptivos eficaces (ej.,abstinencia,preservativo u otro dispositivo de barrera)durante el estudio y durante al menos 30 días después de la última dosis de la medicación del estudio
    7.Capacidad de entender y cumplir los procedimientos tal como se describe en el protocolo según el criterio del investigador y capacidad para firmar el formulario de consentimiento informado antes del inicio de cualquier procedimiento de selección o específico del estudio.Los sujetos deben poder volver al hospital para cumplir con los procedimientos necesarios en caso de que reciban el alta hospitalaria durante el estudio.
    8.Nota: para los sujetos, incluidos los menores y los pacientes con incapacidad médica o deterioro de la consciencia,que no sean capaces de proporcionar el consentimiento informado de forma completamente voluntaria,el representante legal del sujeto (progenitor,tutor o apoderado)debe firmar un documento de consentimiento informado aprobado por el comité de ética de investigación clínica (CEIC) antes del inicio de cualquier procedimiento de selección o específico del estudio. Los sujetos menores deben firmar también un formulario de asentimiento aprobado por un CEIC,a menos que no sea necesario según la normativa local y del centro
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria will not be enrolled in this study:
    1. Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
    2. Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV within 48 hours prior to the first dose of study drug. Ribavirin treatment for current Respiratory Syncytial Virus (RSV) and/or Metapneumovirus (MPV) is allowed and will not require washout
    3. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN AND Total Bilirubin (TB) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for >1 year on more than one assessment) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded
    4. Female subjects with positive serum pregnancy test, planning become pregnant, breastfeeding, or planning to breastfeed throughout the study period
    5. Subjects taking any other investigational drugs used to research or treat PIV
    6. Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
    7. Subjects with known hypersensitivity to DAS181 and/or any of its components
    8. Subjects with ongoing sepsis/septic shock
    No podrán inscribirse en este estudio los sujetos que cumplan cualquiera de los siguientes criterios de exclusión:
    1. Los sujetos no pueden estar en cuidados paliativos o, en opinión del investigador, tener una probabilidad baja de supervivencia durante los primeros 10 días de tratamiento
    2. Sujetos tratados con ribavirina oral, en aerosol o intravenosa (IV) para el tratamiento de VPI en las 48 horas previas a la primera dosis del fármaco del estudio. Se permite el tratamiento con ribavirina para el virus respiratorio sincitial (VRS) y/o metaneumovirus (MNV) actual y no será necesario reposo farmacológico
    3. Sujetos con niveles de alanina aminotransferasa (ALT), aspartato aminotransferasa (AST) o fosfatasa alcalina (FA) ≥ 3 x LSN Y bilirrubina total (BT) ≥ 2 x LSN
    • Nota: los sujetos con ALT/AST/FA ≥ 3 x LSN Y BT ≥ 2 x LSN, que lleven crónicamente estables (durante >1 año en más de una evaluación) debido a patología hepática conocida, incluida neoplasia maligna (primaria o metástasis), medicación crónica, trasplante o infección crónica no serán excluidos
    4. Mujeres con una prueba de embarazo en suero positiva, que planeen quedarse embarazadas, en periodo de lactancia o que planeen amamantar durante el periodo del estudio
    5. Sujetos que tomen cualquier otro fármaco en investigación utilizado para la investigación o el tratamiento de VPI
    6. Enfermedad psiquiátrica o cognitiva o consumo de drogas/alcohol, que, en opinión del investigador principal, podría afectar a la seguridad y/o al cumplimiento del sujeto
    7. Sujetos con hipersensibilidad conocida a DAS181 y/o cualquiera de sus componentes
    8. Sujetos con septicemia/choque septicémico en curso
    E.5 End points
    E.5.1Primary end point(s)
    Percent of subjects who RTRA
    Porcentaje de sujetos con RTRA
    E.5.1.1Timepoint(s) of evaluation of this end point
    by Day 28
    el día 28
    E.5.2Secondary end point(s)
    a. All-cause mortality rate
    b. Percent of subjects who RTRA
    c. Time (in days) to cessation of oxygen support
    d. Percent of subjects who achieve CS
    e. Percent of subjects discharged (without mortality or hospice)
    f. Time (in days) to first hospital discharge (without hospice)
    g. Total number of inpatients days
    h. PIV-related mortality rate
    i. PIV-related mortality rate
    j. All-cause mortality rate
    a. Tasa de mortalidad por cualquier causa
    b. Porcentaje de sujetos con RTRA
    c. Tiempo (en días) hasta la interrupción del oxígeno suplementario
    d. Porcentaje de sujetos que alcanzan la EC
    e. Porcentaje de sujetos que reciben el alta hospitalaria (sin mortalidad ni cuidados paliativos)
    f. Tiempo (en días) hasta la primera alta hospitalaria (sin cuidados paliativos)
    g. Número total de días de hospitalización
    h. Tasa de mortalidad relacionada con VPI
    i. Tasa de mortalidad relacionada con VPI
    j. Tasa de mortalidad por cualquier causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. at Day 28
    b. by Day 21
    c. in days
    d. by Day 28
    e. by Day 14,21,28 and 35
    f. in days
    g. up to Day 35
    h. at Day 28
    i. at Day 35
    j. at Day 35
    a. el día 28
    b. el día 21
    c.en días
    d. el día 28
    e. los días 14, 21, 28 y 35
    f. en días
    g. hasta el día 35
    h. el día 28
    i. el día 35
    j. el día 35
    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 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 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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    China
    Denmark
    France
    Germany
    Hong Kong
    Italy
    Korea, Republic of
    Spain
    Taiwan
    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
    Última Visita 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: 1
    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.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 132
    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)
    Treatment as per normal standard of care.
    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 Decision2020-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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