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    Summary
    EudraCT Number:2019-000718-13
    Sponsor's Protocol Code Number:BT–L-CsA–201–SCT
    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:2019-11-05
    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 number2019-000718-13
    A.3Full title of the trial
    A Phase IIa Multi-Center, Randomized, Single-Blind Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Stem Cell Transplantation.
    Estudio de fase IIa, multicéntrico, aleatorizado y monociego de la seguridad de Ciclosporina A Liposómica en el tratamiento del síndrome de bronquiolitis obliterante tras un alotrasplante de células madre hematopoyéticas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Research Study to Investigate the Safety of Liposomal Cyclosporine A (L-CsA) in Patients with Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Stem Cell Transplantation.
    Estudio para investigar la seguridad de Ciclosporina A Liposómica (L-CsA) en pacientes con síndrome de bronquiolitis obliterante tras un alotrasplante de células madre hematopoyéticas.
    A.3.2Name or abbreviated title of the trial where available
    BOSTON-4
    BOSTON-4
    A.4.1Sponsor's protocol code numberBT–L-CsA–201–SCT
    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 SponsorBreath Therapeutics 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 supportBreath Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBreath Therapeutics Inc.
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address633 Menlo Avenue #230
    B.5.3.2Town/ cityMenlo Park
    B.5.3.3Post codeCA 94025
    B.5.3.4CountryUnited States
    B.5.6E-mailcontact@breath-therapeutics.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/210
    D.3 Description of the IMP
    D.3.1Product nameLiposomal Cyclosporine A
    D.3.2Product code L-CsA
    D.3.4Pharmaceutical form Powder and solvent for nebuliser 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 INNCiclosporin (Ciclosporinium)
    D.3.9.1CAS number 59865-13-3
    D.3.9.3Other descriptive nameCICLOSPORIN A
    D.3.9.4EV Substance CodeSUB129839
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/210
    D.3 Description of the IMP
    D.3.1Product nameLiposomal Cyclosporine A
    D.3.2Product code L-CsA
    D.3.4Pharmaceutical form Powder and solvent for nebuliser 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 INNCiclosporin (Ciclosporinium)
    D.3.9.1CAS number 59865-13-3
    D.3.9.3Other descriptive nameCICLOSPORIN A
    D.3.9.4EV Substance CodeSUB129839
    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.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 and solvent for nebuliser 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
    Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
    Síndrome de bronquiolitis obliterante tras un alotrasplante de células madre hematopoyéticas
    E.1.1.1Medical condition in easily understood language
    Bronchiolitis Obliterans Syndrome in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
    Síndrome de bronquiolitis obliterante tras un alotrasplante de células madre hematopoyéticas
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 of this study is to assess the tolerability and safety, of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for the treatment of BOS in adult allo-HSCT recipients.
    El objetivo principal de este estudio es evaluar la tolerabilidad y seguridad de dos niveles de dosis de L-CsA en aerosol frente a placebo, además de la terapia con SoC para el tratamiento de BOS en receptores de alo-HSCT adultos.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess PK and exploratory efficacy and quality of life of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for the treatment of BOS in adult allo-HSCT recipients.
    Los objetivos secundarios de este estudio son evaluar la PK y la eficacia exploratoria y la calidad de vida de dos niveles de dosis de L-CsA en aerosol frente a placebo, además de la terapia con SoC para el tratamiento de BOS en receptores de alo-HSCT adultos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥ 18 years.
    2. Patient must have a history of allo-HSCT, regardless of source of stem cell or donor or indication for allo-HSCT
    3. Documented diagnosis of cGvHD in any organ other than the lung. If BOS is the only manifestation of cGvHD, lung biopsy must have been performed before entering the trial to confirm BOS diagnosis.
    4.Confirmed diagnosis of BOS Score 1 within > 6 months and < 3 years after allo-HSCT:
    FEV1/FVC < 0.7 at Screening Visit AND
    Post-bronchodilator FEV1 ≥ 60 and ≤ 79% predicted at Screening Visit AND
    ≥10% decline of FEV1 % predicted within 24 months prior to Screening Visit AND
    Absence of acute infection in the respiratory tract.
    5. Patient must be capable of understanding the purposes and risks of the study, has given written informed consent, and agrees to comply with the study requirements.
    6. Patient is capable of aerosol inhalation.
    7. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at randomization visit.
    1. Edad ≥18 años.
    2. El paciente debe haberse sometido a un alo-TCMH, independientemente del origen o donante de las células madre o la indicación del alo-TCMH.
    3. Diagnóstico documentado de enfermedad de injerto contra huésped crónica (EICHc) en cualquier órgano excepto en los pulmones. Si el SBO es la única manifestación de la EICHc, debe haberse realizado una biopsia de pulmón antes de entrar en el ensayo para confirmar el diagnóstico de SBO.
    4. Diagnóstico confirmado de SBO con puntuación 1 [Jagasia et al. 2015] en el plazo de >6 meses y <3 años tras el alo-TCMH: Volumen espiratorio forzado en un segundo (VEF1)/capacidad vital forzada (CVF) <0,7 en la visita de selección Y
    VEF1 después de utilizar un broncodilatador ≥60 y ≤79 % del valor predicho en la visita de selección Y
    Descenso ≥10 % del porcentaje predicho del VEF1 en los 24 meses anteriores a la visita de selección Y
    Ausencia de infección aguda de las vías respiratorias.
    5. El paciente debe ser capaz de entender los propósitos y los riesgos del estudio, haber otorgado el consentimiento informado por escrito y aceptar cumplir con los requisitos del estudio.
    6. El paciente debe ser capaz de inhalar aerosoles.
    7. Las mujeres en edad fértil deben tener una prueba de embarazo en suero o en orina negativa en la selección y en la visita de aleatorización.
    E.4Principal exclusion criteria
    1.Active bacterial, viral (as confirmed by multiplex PCR) or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit.
    2.Chronic renal dysfunction with serum creatinine ≥ 2.5 mg/dL or need for renal dialysis.
    3.Chronic hepatic dysfunction with serum total bilirubin > 5x upper limit of normal (ULN), transaminases > 5x ULN, or alkaline phosphatase > 5x ULN.
    4. Evidence of relapse of the primary malignancy which warranted allogeneic bone marrow transplant.
    5. Use of azithromycin within 4 weeks prior to Randomization (Visit 1).
    6. Use of zafirlukast during the study period.
    7. Chronic oxygen use or use of non-invasive ventilation.
    8. Active smokers (i.e. any kind of inhaled nicotine consumption).
    9. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy over the course of the clinical trial (for details see Appendix II).
    10. Women who are currently breastfeeding.
    11. Known hypersensitivity to L-CsA or to cyclosporine A.
    12. Patients who do not tolerate administration of inhaled bronchodilators (e.g., salbutamol).
    13. Patients with life-expectancy of less than 6 months.
    14. Treatments with other Investigational Medicinal Products (IMPs) or previous therapies within four weeks or five times half-life of
    the drug, whichever is longer prior to screening and during the study. Participation in registries, considering the before, is allowed.
    15. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion
    of the necessary procedures.
    16. Any co-existing medical condition that in the Investigator’s judgment will substantially increase the risk associated with the patient’s participation in the clinical trial.
    17. Pre-scheduled hospitalizations, surgeries or interventions planned
    to be performed after obtaining Informed Consent for this study.
    1. Infección bacteriana, vírica (confirmada mediante PCR múltiple) o fúngica activa no resuelta con éxito al menos 4 semanas antes de la visita de selección.
    2. Disfunción renal crónica con creatinina sérica ≥2,5 mg/dl o necesidad de diálisis renal.
    3. Disfunción hepática crónica con bilirrubina sérica total >5 veces el límite superior de la normalidad (LSN), transaminasas >5 veces el LSN o fosfatasa alcalina >5 veces el LSN.
    4. Indicios de recidiva de la neoplasia maligna primaria que requirió el alotrasplante de médula ósea.
    5. Uso de azitromicina en las 4 semanas anteriores a la aleatorización (visita 1).
    6. Uso de zafirlukast durante el periodo del estudio.
    7. Uso crónico de oxígeno o uso de ventilación no invasiva.
    8. Fumadores activos (es decir, cualquier tipo de consumo de nicotina inhalada).
    9. Mujeres embarazadas o mujeres que no quieran utilizar un anticonceptivo adecuado para evitar el embarazo durante el ensayo clínico (ver el Anexo II para más información).
    10. Mujeres que estén actualmente en periodo de lactancia materna.
    11. Hipersensibilidad conocida a L-CsA o a la ciclosporina A.
    12. Pacientes que no toleran la administración de broncodilatadores inhalados (p. ej., salbutamol).
    13. Pacientes con una esperanza de vida inferior a 6 meses.
    14. Tratamientos con otros productos en fase de investigación (PEI) o tratamientos previos en el plazo de cuatro semanas o cinco veces la semivida del medicamento, cualquiera que sea más largo, antes de la selección y durante el estudio. Se permite la participación en registros, teniendo en cuenta lo anterior.
    15. Pacientes con trastornos psiquiátricos o alteraciones del estado mental que les impidan entender el proceso para otorgar el consentimiento informado y/o completar los procedimientos necesarios.
    16. Cualquier afección médica coexistente que, en opinión del investigador, aumente sustancialmente el riesgo asociado a la participación del paciente en el ensayo clínico.
    17. Hospitalizaciones, intervenciones quirúrgicas o intervenciones previamente programadas a realizar después de obtener el consentimiento informado para este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    IMP tolerability and safety during the first 4 weeks of treatment

    IMP Tolerability Parameters:
    • Local Tolerability:
    o Cough
    o Wheezing
    o Bronchospasm
    o Throat irritation
    o Change in FEV1

    •Overall Tolerability:
    o Clinical Global Impressions (CGI) scale
    o Investigator’s tolerability assessment at Visit 3

    Safety Parameters:
    • Adverse events (AEs)
    • Serious adverse events (SAEs)
    • Clinical laboratory values
    • Vital signs
    Tolerabilidad y seguridad del medicamento en investigación durante las primeras 4 semanas de tratamiento.

    Parámetros de tolerabilidad del medicamento en investigación:
    • Tolerabilidad local:
    o Tos
    o Sibilancias
    o Broncoespasmo.
    o Irritación de garganta.
    o Cambio en el VEF1

    • Tolerabilidad global:
    o Escala de impresión clínica global (CGI).
    o Evaluación de tolerabilidad del investigador en la visita 3.

    Parámetros de seguridad:
    • Acontecimientos adversos (AA).
    • Acontecimientos adversos graves (AAG).
    • Valores de laboratorio clínico.
    • Constantes vitales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    IMP tolerability and safety during the first 4 weeks of treatment

    Please refer to 'Schedule of Activities' in the Protocol
    Tolerabilidad y seguridad del medicamento en investigación durante las primeras 4 semanas de tratamiento.

    Por favor, consulte el Calendario de actividades en el protocolo.
    E.5.2Secondary end point(s)
    IMP tolerability and safety during the first 12 weeks of treatment;

    IMP Tolerability Parameters:
    • Local Tolerability:
    o Cough
    o Wheezing
    o Bronchospasm
    o Throat irritation
    o Change in FEV1

    •Overall Tolerability:
    o Clinical Global Impressions (CGI) scale
    o Investigator’s tolerability assessment at Visit 3

    Safety Parameters:
    • Adverse events (AEs)
    • Serious adverse events (SAEs)
    • Clinical laboratory values
    • Vital signs

    CsA Pharmacokinetic Parameters:
    o Cmax
    o tmax
    o AUC0-4h
    • Whole blood trough levels
    Tolerabilidad y seguridad del medicamento en investigación durante las primeras 12 semanas de tratamiento.

    Parámetros de tolerabilidad del medicamento en investigación:
    • Tolerabilidad local:
    o Tos
    o Sibilancias
    o Broncoespasmo.
    o Irritación de garganta.
    o Cambio en el VEF1

    • Tolerabilidad global:
    o Escala de impresión clínica global (CGI).
    o Evaluación de tolerabilidad del investigador en la visita 3.

    Parámetros de seguridad:
    • Acontecimientos adversos (AA).
    • Acontecimientos adversos graves (AAG).
    • Valores de laboratorio clínico.
    • Constantes vitales.

    Parámetros farmacocinéticos de CsA
    o Cmáx
    o tmáx
    o AUC0-4h
    • Niveles mínimos en sangre entera
    E.5.2.1Timepoint(s) of evaluation of this end point
    IMP tolerability and safety during the first 12 weeks of treatment;

    Pharmacokinetic Parameters:
    • PK: (Week 0) at pre-dose; directly after end of inhalation; 15, 30, and 45 minutes, and 1, 1.5, 2, and 4 hours after end of inhalation:
    • Whole blood trough levels (at Weeks 2, 4, 8, and 12)

    Please refer to 'Schedule of Activities' in the Protocol
    Tolerabilidad y seguridad del medicamento en investigación durante las primeras 12 semanas de tratamiento.

    Parámetros farmacocinéticos:
    • FC: (Semana 0) antes de la dosis; directamente después de finalizar la inhalación; 15, 30 y 45 minutos, y 1, 1,5, 2 y 4 horas después de finalizar la inhalación:
    • Niveles mínimos en sangre entera (en las semanas 2, 4, 8 y 12).

    Por favor, consulte el Calendario de actividades en el protocolo.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 Yes
    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 Yes
    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 concerned5
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LSLV
    UPUV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days7
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 24
    F.4.2.2In the whole clinical trial 24
    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 - Standard Treatment of Care.
    Ninguno - Práctica Habitual
    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 Decision2019-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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