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    Summary
    EudraCT Number:2020-001966-13
    Sponsor's Protocol Code Number:EDP938-201
    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:2021-07-27
    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 number2020-001966-13
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 24 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)
    Estudio de fase II, aleatorizado, doble ciego, controlado con placebo y de 2 partes, para evaluar pautas de tratamiento de EDP-938 en pacientes de 28 días a 24 meses de edad con infección por el virus respiratorio sincitial
    (VRS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of EDP-938 in subjects aged 28 days to 24 months infected with respiratory syncytial virus (RSV)
    Evaluación de EDP-938 en pacientes de 28 días a 24 meses de edad con infección por el virus respiratorio sincitial (VRS)
    A.3.2Name or abbreviated title of the trial where available
    RSVPEDs
    A.4.1Sponsor's protocol code numberEDP938-201
    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 SponsorEnanta Pharmaceuticals, 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 supportEnanta Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEnanta Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMaria Gawryl
    B.5.3 Address:
    B.5.3.1Street Address500 Arsenal Street
    B.5.3.2Town/ cityWatertown
    B.5.3.3Post codeMA 02472
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16177443226
    B.5.6E-mailmgawryl@enanta.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 nameEDP-938
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number 2070852-76-3
    D.3.9.2Current sponsor codeEDP-938
    D.3.9.3Other descriptive nameEP-023938, EP-3938, EPS-3938, EPC-3938
    D.3.9.4EV Substance CodeSUB214949
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    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
    Respiratory Syncytial Virus (RSV)
    Virus respiratorio sincitial (VRS)
    E.1.1.1Medical condition in easily understood language
    Respiratory Syncytial Virus (RSV) can infect the lungs and windpipe. The infection could be particularly severe for small children, the elderly and in people with weak immune systems.
    Virus respiratorio sincitial (VRS) puede infectar los pulmones y la tráquea. La infección podría ser particularmente grave para niños pequeños, ancianos y personas con sistemas inmunológicos débiles.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    • To evaluate the PK of EDP-938
    • To assess the safety and tolerability of EDP-938
    Part 2
    • To evaluate the antiviral activity of EDP-938
    Parte 1
    • Evaluar la FC de EDP-938.
    • Evaluar la seguridad y tolerabilidad de EDP-938.
    Parte 2
    • Evaluar la actividad antivírica de EDP-938.
    E.2.2Secondary objectives of the trial
    Part 1
    • To evaluate the antiviral activity of EDP-938
    Part 2
    • To assess the safety and tolerability of EDP-938
    • To evaluate the PK of EDP-938
    Parte 1
    • Evaluar la actividad antivírica de EDP-938.
    Parte 2
    • Evaluar la seguridad y tolerabilidad de EDP-938.
    • Evaluar la FC de EDP-938.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female who is either:
    • born ≥37 weeks of gestation and is age ≥28 days to ≤24 months, defined at the time of randomization, or
    • born <37 weeks of gestation and is age ≥6 months to ≤24 months, defined at the time of randomization
    2. Subjects diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection by another respiratory pathogen (respiratory virus, fungus, or bacteria)
    3. Subjects with signs of an acute respiratory illness (eg, fever [or symptoms of fever], cough, nasal congestion, runny nose, rapid breathing, shortness of breath, or wheezing) with onset ≤72 hours (for hospitalized subjects) and ≤48 hours (non-hospitalized subjects) before the time of signing the informed consent form (ICF)
    Note: Time of onset of symptoms is defined from the caregiver(s) estimated time of awareness of the first sign of respiratory infection
    4. Have a calculated creatinine clearance rate not below the lower limit of normal (LLN) for the subject’s age as determined by the Schwartz equation (Schwartz & Work, 2009) at Screening
    5. In the Investigator’s opinion, the subject’s caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned

    Additional inclusion criterion for Part 1 Cohort 1
    6. Subject is currently or is planned to be hospitalized as a consequence of RSV infection and is not anticipated to be discharged in less than 24 hours after enrollment
    1.Varón o mujer:
    nacido tras ≥37 semanas de gestación y edad de ≥28 días a ≤24 meses, definido en el momento de la aleatorización; o
    nacido tras <37 semanas de gestación y edad de ≥6 meses a ≤24 meses, definido en el momento de la aleatorización.
    2.Pacientes diagnosticados con infección por el VRS mediante un ensayo diagnóstico aprobado, sin coinfección conocida y/o documentada por otro patógeno respiratorio (virus respiratorios, hongos o bacterias).
    3.Pacientes con signos de enfermedad respiratoria aguda (p. ej., fiebre [o síntomas de fiebre], tos, congestión nasal, rinorrea, respiración rápida, dificultad para respirar o sibilancias) con aparición ≤72 horas (para los pacientes hospitalizados) y ≤48 horas (para los pacientes no hospitalizados) antes del momento de la firma del FCI.
    Nota: El momento de aparición de los síntomas se define a partir del momento estimado por los cuidadores del conocimiento del primer signo de infección respiratoria.
    4.Tener un índice de aclaramiento de creatinina calculado no inferior al límite inferior de la normalidad (LIN) para la edad del paciente según lo determinado por la ecuación de Schwartz (Schwartz & Work, 2009) en la selección.
    5.En opinión del investigador, el cuidador del paciente entiende y es capaz de cumplir con los requisitos, instrucciones y restricciones establecidos por el protocolo, y es probable que el paciente complete el estudio según lo previsto.
    Criterio de inclusión adicional para la parte 1, cohorte 1
    6.El paciente está hospitalizado o está previsto que sea hospitalizado como consecuencia de la infección por el VRS y no se prevé que reciba el alta hospitalaria en menos de 24 horas después de la inclusión.
    E.4Principal exclusion criteria
    1. Use of or anticipated need for intensive monitoring and associated medical care, eg admission to ICU or equivalent medical setting, requirement for mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
    2. Subjects who have a medical history or a concurrent illness that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments. Examples include liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic conditions
    3. Subjects who are considered unable to take study drug orally, eg, as a consequence of acute respiratory distress, or unable to absorb study drug enterally
    4. Subjects who have received blood products within 6 months of study drug administration
    5. Height or weight outside of the 5th to 95th percentile for the respective ages, at the time of enrollment
    6. Subjects with underlying immune deficiency, eg, from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency
    7. Subjects who received (within 12 months before Screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
    8. Subjects who have had major surgery in the 6 weeks before randomization
    9. Subject receiving chronic oxygen therapy at home before admission
    10. Subjects who are being breastfed by a mother taking any of the excluded medications
    11. Subjects whose mother received an investigational RSV vaccination while pregnant with the subject
    12. Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days of Screening
    13. Subjects who received systemic medications (either chronically [more than 14 days] or within 21 days before randomization) that are known to modulate the host’s immune response or increase viral shedding, such as immunomodulatory therapies
    14. Subjects who are receiving an investigational or approved medication that is intended to prevent or treat RSV infection (eg, ribavirin or palivizumab or other RSV specific monoclonal antibody) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug, and/or is currently enrolled in a clinical trial of such a medication
    15. Use of or intention to use any medication or supplement known to be a moderate or strong inducer or inhibitor of the cytochrome P450 3A4 enzyme within 14 days before the first dose of study drug
    16. Subjects who are enrolled in another investigational drug or vaccine study
    17. Known allergy/hypersensitivity or intolerance to EDP-938 or its excipients
    1.Uso o necesidad anticipada de supervisión intensiva y de la atención médica asociada, por ejemplo, ingreso en UCI o entorno médico equivalente, necesidad de ventilación mecánica, derivación cardiopulmonar, hemodiálisis u oxigenación por membrana extracorpórea; o pacientes que no se espera que sobrevivan a la enfermedad actual.
    2.Pacientes con antecedentes médicos o enfermedad concomitante que, en opinión del investigador, puedan generar confusión en los resultados del estudio o suponer un riesgo adicional en la administración del fármaco del estudio al paciente, o que pudieran impedir, limitar o confundir las evaluaciones especificadas en el protocolo. Algunos ejemplos son la insuficiencia hepática o renal; enfermedades cardíacas, vasculares, pulmonares, gastrointestinales, endocrinas, neurológicas, hematológicas, reumatológicas o metabólicas significativas.
    3.Pacientes considerados incapaces de tomar el fármaco del estudio por vía oral, p. ej., como consecuencia de dificultad respiratoria aguda o que no puedan absorber el fármaco del estudio por sonda nasogástrica.
    4.Pacientes que han recibido hemoderivados en los 6 meses anteriores a la administración del fármaco del estudio.
    5.Estatura o peso fuera de los percentiles 5 a 95 para las respectivas edades en el momento de la inclusión.
    6.Pacientes con inmunodeficiencia subyacente, p. ej., de infección confirmada por el virus de la inmunodeficiencia humana o uso de inmunosupresores, salvo deficiencia de inmunoglobulina A.
    7.Pacientes que hayan recibido (en los 12 meses anteriores a la selección) o que estén actualmente en una lista de espera para un trasplante de médula ósea, de células madre o de órganos sólidos, o que hayan recibido radiación o quimioterapia (en los 12 meses anteriores a la selección).
    8.Pacientes sometidos a cirugía mayor en las 6 semanas anteriores a la aleatorización.
    9.El paciente recibe tratamiento con oxígeno crónico en casa antes del ingreso.
    10.Pacientes alimentados con leche materna por una madre que toma cualquiera de los medicamentos excluidos.
    11.Pacientes cuya madre recibió una vacuna en investigación contra el VRS mientras estaba embarazada del paciente.
    12.Recepción de tratamiento sistémico antivírico, antibacteriano, antifúngico o antimicobacteriano en los 7 días previos a la selección.
    13.Pacientes que hayan recibido medicamentos sistémicos (crónicos [de más de 14 días] o en los 21 días previos a la aleatorización) que se sepa que modulan la respuesta inmunitaria del hospedador o que aumentan la excreción vírica, como tratamientos inmunomoduladores.
    14.Pacientes que estén recibiendo un medicamento en investigación o aprobado destinado a prevenir o tratar la infección por el VRS (p. ej., ribavirina o palivizumab u otro anticuerpo monoclonal específico contra el VRS) en los 30 días o 5 semividas (lo que sea más largo) anteriores a la administración de la primera dosis del fármaco del estudio, y/o que estén incluidos en ese momento en un ensayo clínico de dicho medicamento.
    15.Uso o intención de uso de cualquier medicamento o suplemento que se sepa que es un inductor moderado o potente de la enzima 3A4 del citocromo P450 en los 14 días anteriores a la primera dosis del fármaco del estudio.
    16.Pacientes incluidos en otro estudio con fármaco en investigación o vacunas.
    17.Alergia/hipersensibilidad conocida o intolerancia a EDP-938 o sus excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    1) PK parameters of EDP-938 including area under the curve (AUC) and predose concentrations
    2) Safety and tolerability of EDP-938 compared to placebo as assessed by, but not limited to, AEs, vital signs, and clinical laboratory results
    Part 2
    1) Daily change in RSV shedding in nasal swab samples determined using quantitative RT-PCR from before the first dose of study drug (Baseline) through treatment phase
    Parte 1
    1) FC de EDP-938, incluidos el área bajo la curva (ABC) y las concentraciones previas a la dosis.
    2) Seguridad y tolerabilidad de EDP-938 en comparación con placebo, evaluadas por, entre otros, AAs, constantes vitales y resultados de laboratorio clínico.
    Parte 2
    1) Cambio diario en la excreción del VRS en muestras de exudado nasal determinado mediante RCP-TI cuantitativa desde antes de la primera dosis del fármaco del estudio (inicio) hasta la fase de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1
    1) From Day 1 up to 10 hours post Day 5 dose
    2) From baseline up to Day 28

    Part 2
    1) From baseline up to Day 14
    Parte 1
    1) Desde el día 1 hasta 10 horas después de la dosis del día 5.
    2) Desde el inicio hasta el día 28
    Parte 2
    1) Desde inicio hasta el día 14
    E.5.2Secondary end point(s)
    Part 1
    1) AUC for RSV RNA viral load measured in nasal swab samples by quantitative reverse transcription polymerase chain reaction (RT-qPCR)
    2) Daily change in RSV shedding in nasal swab samples determined using quantitative RT-PCR from before the first dose of study drug (Baseline) through treatment phase
    3) Proportion of subjects with RSV RNA viral load below the limit of detection (LOD) in subjects receiving EDP-938 compared to placebo
    4) Time to RSV RNA viral load being undetectable

    Part 2:
    1) Safety and tolerability of EDP-938 compared to placebo as assessed by, but not limited to, AEs, vital signs, and clinical laboratory results
    2) AUC for RSV RNA viral load measured in nasal swab samples by RT-qPCR
    3) Proportion of subjects with RSV RNA viral load below the LOD in subjects receiving EDP-938 compared to placebo
    4) Time to RSV RNA viral load being undetectable
    5) PK parameters of EDP-938 including AUC and predose concentrations
    Parte 1
    1) ABC para la carga vírica del ARN del VRS medida en muestras de exudado nasal mediante RCP-TIc.
    2) Cambio diario en la excreción del VRS en muestras de exudado nasal determinado mediante RCP-TI cuantitativa desde antes de la primera dosis del fármaco del estudio (inicio) hasta la fase de tratamiento.
    3) Proporción de pacientes con carga vírica del ARN del VRS por debajo del LdD en pacientes que reciben EDP-938 en comparación con placebo.
    4) Tiempo transcurrido hasta que la carga vírica del ARN del VRS sea indetectable.

    Parte 2
    1) Seguridad y tolerabilidad de EDP-938 en comparación con placebo, evaluadas por, entre otros, AA, constantes vitales y resultados de laboratorio clínico.
    2) ABC para la carga vírica del ARN del VRS medida en muestras de exudado nasal mediante RCP-TIc.
    3) Proporción de pacientes con carga vírica del ARN del VRS por debajo del LdD en pacientes que reciben EDP-938 en comparación con placebo.
    4) Tiempo transcurrido hasta que la carga vírica del ARN del VRS sea indetectable.
    5) Parámetros FC de EDP-938, incluidos el ABC y las concentraciones previas a la dosis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1:
    1) From baseline up to Day 14
    2) From baseline up to Day 14
    3) From baseline up to Day 14
    4) From baseline up to Day 14

    Part 2:
    1) From baseline up to Day 28
    2) From baseline up to Day 14
    3) From baseline up to Day 14
    4) From baseline up to Day 14
    5) From Day 1 up to 10 hours post Day 5 dose
    Parte 1:
    1) Desde el inicio hasta el día 14
    2) Desde el inicio hasta el día 14
    3) Desde el inicio hasta el día 14
    4) Desde el inicio hasta el día 14
    Parte 2:
    1) Desde el inicio hasta el día 28
    2) Desde el inicio hasta el día 14
    3) Desde el inicio hasta el día 14
    4) From baseline up to Day 14
    5) Desde el día 1 hasta 10 horas después de la dosis del día 5
    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 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Brazil
    Israel
    Korea, Republic of
    Mexico
    South Africa
    Taiwan
    United States
    Bulgaria
    Germany
    Poland
    Romania
    Spain
    United Kingdom
    Argentina
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 90
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 2
    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: 82
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    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 and toddlers (≥28 days to ≤24 months)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 90
    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
    ninguno
    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 Decision2021-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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