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    Summary
    EudraCT Number:2018-003775-35
    Sponsor's Protocol Code Number:SHP655-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 number2018-003775-35
    A.3Full title of the trial
    A Phase 2, multicenter, randomized, placebo-controlled, double-blind study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment
    Estudio de fase II, multicéntrico, aleatorizado, con doble enmascaramiento, controlado con placebo en pacientes con púrpura trombocitopénica trombótica adquirida (PTTa) para evaluar la farmacocinética, la seguridad y la eficacia de rADAMTS-13 (SHP655) administrado junto con el tratamiento de la práctica clínica habitual
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, randomized, placebo-controlled, double-blind study of
    rADAMTS-13 (SHP655) in the treatment of patients with aTTP
    Estudio en fase II, aleatorizado, controlado con placebo, con doble enmascaramiento de rADAMTS-13 (SHP655) en el tratamiento de pacientes con PTTa
    A.4.1Sponsor's protocol code numberSHP655-201
    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 SponsorBaxalta Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxalta Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxalta US Inc.
    B.5.2Functional name of contact pointArchana Savla
    B.5.3 Address:
    B.5.3.1Street Address650 East Kenadall Street,
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02191
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34917904222
    B.5.6E-mailarchana.savla@takeda.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/3/08/588
    D.3 Description of the IMP
    D.3.1Product nameRecombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
    D.3.2Product code SHP 655 (BAX 930)
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNapadamtase alfa
    D.3.9.2Current sponsor codeSHP655
    D.3.9.3Other descriptive nameBAX930 - RECOMBINANT HUMAN ADAMTS13
    D.3.9.4EV Substance CodeSUB183727
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.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/3/08/588
    D.3 Description of the IMP
    D.3.1Product nameRecombinant A Disintegrin And Metalloproteinase with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
    D.3.2Product code SHP 655 (BAX 930)
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNapadamtase alfa
    D.3.9.2Current sponsor codeSHP655
    D.3.9.3Other descriptive nameBAX930 - RECOMBINANT HUMAN ADAMTS13
    D.3.9.4EV Substance CodeSUB183727
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acquired thrombotic thrombocytopenic purpura (aTTP)
    púrpura trombocitopénica trombótica adquirida (PTTa)
    E.1.1.1Medical condition in easily understood language
    acquired blood disorder
    trastorno sanguíneo adquirido
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10043648
    E.1.2Term Thrombotic thrombocytopenic purpura
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Co-Primary:
    1. Assess the PK of ADAMTS-13 in aTTP subjects treated for an acute episode by daily plasma exchange (PEX), immunosuppressant therapy, with or without SHP655 supplementation
    2. Study the PK/PD relationship between ADAMTS-13 levels and pathophysiological biomarkers, as well as clinical efficacy parameters
    Coprincipales:
    1.Evaluar la FC de ADAMTS-13 en sujetos con PTTa tratados por un episodio agudo con PF diaria o tratamiento inmunosupresor, con o sin administración complementaria de SHP655.
    2.Estudiar la relación de FC/FD entre los niveles de ADAMTS-13 y los biomarcadores fisiopatológicos, así como los parámetros de eficacia clínica.
    E.2.2Secondary objectives of the trial
    PK/PD Objectives
    1. Evaluate changes in levels of ADAMTS-13 binding and inhibitory autoantibodies in response to daily PEX, with or without SHP655 supplementation, during the acute episode and up to 30 days after the resolution of the TTP episode

    2. Evaluate ADAMTS-13 activity levels in subjects up to 30 days after TTP episode remission

    3. Specify dose(s) of SHP655 needed to achieve and maintain adequate plasma levels of rADAMTS-13

    Safety/Efficacy Objectives
    1. Assess the safety and immunogenicity of two regimens of SHP655 supplementation administered during an acute TTP episode in subjects undergoing PEX treatment and immunosuppressant therapy

    2. Evaluate the occurrences of aTTP related complications, aTTP relapses, exacerbations and end-organ function improvement

    3. Evaluate the time to aTTP related complications, aTTP relapses, exacerbations and end-organ function improvement

    4. Evaluate the occurrence of procedure related adverse events
    Objetivos de FC/FD
    1.Evaluar los cambios en los niveles de autoanticuerpos de unión e inhibidores de ADAMTS-13 en respuesta a la PF diaria, con o sin administración complementaria de SHP655, durante el episodio agudo y hasta 30 días después de la resolución del episodio de PTT.
    2.Evaluar los niveles de actividad de ADAMTS-13 en los sujetos hasta 30 días después de la remisión de un episodio de PTT.
    3.Especificar las dosis necesarias de SHP655 para lograr y mantener de forma adecuada los niveles plasmáticos de rADAMTS-13 para respaldar la inducción de la remisión y para reducir el número de procedimientos necesarios de PF para el tratamiento de los episodios agudos de PTTa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject or legally authorized representative voluntarily signs informed consent. For subjects unable to provide consent, a fully recognized medical proxy may be used according to local laws.
    2. Subject is 18 to 75 years old at the time of screening.
    3. Subject has been diagnosed with primary or secondary autoimmune aTTP based on the following criteria:
    a. Thrombocytopenia [drop in platelet count ≥50% or platelet count < 100,000/μL];
     No more than 3 subjects per arm may be enrolled with a screening platelet count ≥50,000/ μL.
    b. Microangiopathic hemolytic anemia [elevation of lactate dehydrogenase (LDH) >2-fold or by presence or increase of schistocytes in peripheral blood smear].
    4. Willingness to fully comply with study procedures and requirements, and intention to initiate plasma exchange (PEX). Subjects may be provisionally entered into the trial and undergo randomization pending the results of the ADAMTS-13 activity, anti-ADAMTS-13 antibody, and genetic testing for cTTP.
    5. If female of childbearing potential, subject presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study. Sexually active males must use an accepted and effective method of contraception during the treatment and until a minimum of 16 days after the last dose administered.
    1.El sujeto o su representante legal firman el consentimiento informado de forma voluntaria. Un representante médico plenamente reconocido puede actuar en representación de los sujetos que no pueden dar su consentimiento, según la legislación local.
    2. El sujeto tiene entre 18 y 75 años en el momento de la selección
    3.El sujeto ha sido diagnosticado con PTTa autoinmune primaria o secundaria, en función de los siguientes criterios:
    a.Trombocitopenia (descenso en el recuento de plaquetas ≥50 % o un recuento de plaquetas <100 000/µl).
    No se puede inscribir a más de 3 sujetos por grupo con un recuento de plaquetas de ≥50 000/µl en la selección.
    b.Anemia hemolítica microangiopática (aumento de lactato deshidrogenasa [LDH] de más del doble o por la presencia o incremento de esquistocitos en el frotis de sangre periférica).
    4.Disposición para cumplir plenamente con los procedimientos y requisitos del estudio e intención de comenzar una PF. Es posible que los sujetos comiencen el ensayo y se sometan a la aleatorización a la espera de los resultados de la actividad de ADAMTS-13, el anticuerpo anti-ADAMTS-13 y las pruebas genéticas de PTTc.
    5.En el caso de mujeres en edad fértil, deben presentar una prueba de embarazo negativa y acceder a utilizar métodos anticonceptivos adecuados durante todo el estudio. Los hombres sexualmente activos deben utilizar un método anticonceptivo aceptado y eficaz durante el tratamiento y hasta un mínimo de 16 días después de la última dosis administrada.
    E.4Principal exclusion criteria
    1. Subject has been diagnosed with congenital TTP.
    2. Subject has plasma ADAMTS-13 activity> 10% of normal at the central lab.
    3. Subject has been diagnosed with another cause of thrombotic microangiopathy (TMA) including: DIC, disseminated malignancy, malignant hypertension, hematopoietic stem cell transplantation, shiga toxin-related
    and atypical HUS, drug toxicity (e.g. gemcitabine, mitomycin C, clopidogrel) and pregnancy-related thrombocytopenia syndromes (e.g. HELLP, eclampsia).
    4. Subject has been exposed to another IP within 30 days prior to enrollment or is scheduled to participate in another clinical study involving IP or investigational device during the course of the study.
    5. Subject has received caplacizumab within 3 months of study enrollment.
    6. Subject is human immunodeficiency virus positive (HIV+) with unstable disease or CD4+ count ≤200 cells/mm3 within 3 months screening.
    7. Subject has had a previous aTTP event in the past 30 days.
    8. Subject has another underlying progressive fatal disease and/or life expectancy of less than 3 months.
    9. Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.
    10. Subject suffers from a mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude. However, a fully recognized medical proxy will be permitted to provide consent.
    11. If female, subject is pregnant or lactating.
    12. Subject is a family member or employee of the Sponsor or investigator.
    13. Any contraindication to PEX, methylprednisolone and/or rituximab as per prescribing information.
    14. Known life-threatening hypersensitivity reaction, including anaphylaxis, to the parent molecule ADAMTS-13, hamster protein, or other constituents of SHP655.
    1. Sujetos diagnosticados con PTT congénita.
    2.Sujetos con una actividad plasmática de ADAMTS-13 >10 % del nivel normal en el laboratorio central.
    3.Sujetos a los que se les ha diagnosticado otra causa de MAT, incluyendo: CID, neoplasia maligna diseminada, hipertensión maligna, trasplante de células madre hematopoyéticas, SUH atípico y relacionado con la toxina Shiga, toxicidad farmacológica (p. ej., gemcitabina, mitomicina C, clopidogrel) y síndromes de trombocitopenia relacionados con el embarazo (p. ej., síndrome de hemólisis, elevación de las enzimas hepáticas y trombocitopenia [HELLP] y eclampsia).
    4.Sujetos que han estado expuestos a otro PEI en los 30 días anteriores a la inscripción o está programado que participen en otro estudio clínico con un PEI o un dispositivo en investigación durante el transcurso de este estudio.
    5.Sujetos que han recibido caplacizumab en los 3 meses anteriores a la inscripción en el estudio.
    6.Sujetos positivos para el virus de la inmunodeficiencia humana (VIH+) y enfermedad inestable o recuento de CD4+ ≤200 células/mm3 en los 3 meses anteriores a la selección.
    7.Sujetos que han tenido un episodio de PTTa en los últimos 30 días.
    8.Sujetos que presentan otra enfermedad mortal progresiva subyacente y/o una esperanza de vida inferior a los 3 meses.
    9.Determinación por el investigador de que el sujeto no es capaz de colaborar con los procedimientos del estudio o no está dispuesto a hacerlo.
    10.Sujetos con una enfermedad mental que les incapacita para entender la naturaleza, el alcance y las posibles consecuencias del estudio, o bien con indicios de una actitud poco colaboradora. Sin embargo, un representante médico plenamente reconocido podrá dar su consentimiento.
    11.Mujeres que estén embarazadas o en periodo de lactancia.
    12.Sujetos que son familiares o empleados del promotor o el investigador.
    13.Cualquier contraindicación para la PF, metilprednisolona y/o rituximab, según la ficha técnica.
    14.Reacción de hipersensibilidad que amenaza la vida, incluida la anafilaxis, a la molécula principal ADAMTS-13, proteína de hámster u otros constituyentes de SHP655.
    E.5 End points
    E.5.1Primary end point(s)
    1. ADAMTS-13 activity levels
    2. Platelet count and LDH levels
    1.Niveles de actividad de ADAMTS-13
    2.Recuento de plaquetas y niveles de LDH
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various time points throughout the study
    Varios puntos de tiempo a lo largo del estudio.
    E.5.2Secondary end point(s)
    PK/PD Endpoints
    1. The PK/PD temporal relationship of efficacy parameters (e.g., platelet count, LDH levels), as a function of ADAMTS-13 activity
    2. The ADAMTS-13 binding and inhibitory autoantibody levels in response to daily PEX, with or without SHP655 supplementation, during the acute TTP episode and up to 30 days after resolution
    3. ADAMTS-13 activity levels in subjects receiving additional SHP655 for up to 30 days after the resolution of the TTP episode
    4. The relationship between ADAMTS-13 activity and end-organ disease status (e.g., renal, neurologic, and cardiac)
    5. PK parameters such as incremental recovery, area under the curve, systemic and antibody induced clearance, maximum ADAMTS-13 activity between PEX or SHP 655 infusions, and trough levels prior PEX
    6. Occurrence of ADAMTS-13 activity trough levels >10%

    Safety/Efficacy endpoints
    1. Time to normalization of platelet count, defined as platelet count ≥ 150,000/μL, which must be confirmed by a second normal platelet count ≥ 150,000/μL and LDH <2 ULN 48 hours following initial normalization
    2. Occurrence of remission, defined as a normal platelet count and LDH <2 ULN for at least 48 hours following initial normalization of platelet count (acute episode period)
    3. Time to first exacerbation (aTTP episode ≤30 days following remission)
    4. Time to relapse (aTTP episode >30 days following remission)
    5. Occurrence of exacerbation
    6. Occurrence of relapse
    7. Occurrence of major clinical events related to TTP including: a. Death, b. Stroke, c. MI
    d. Organ dysfunction not normalized within the 90-day observation period; i. Chronic renal insufficiency, ii. Neurologic impairment, iii. Neurocognitive deficits.
    8. Incidence of major clinical events related to PEX, including clinically relevant bleeding (modified ITP score) or thrombosis at the site of line insertion, adverse reactions to plasma, including citrate reactions, allergic reactions, and TRALI
    9. Changes in the titer of binding and inhibitory antibodies to ADAMTS-13
    10. Occurrence of antibodies to SHP655
    11. Incidence of AEs and SAEs, and specifically product-related AEs and SAEs
    12. Clinically relevant changes in vital signs, clinical chemistry, and hematology
    Criterios de valoración farmacocinéticos
    1.La relación temporal de FC/FD de los parámetros de eficacia (p. ej., recuento de plaquetas, niveles de LDH), como una función de la actividad de ADAMTS-13.
    2.Los niveles de anticuerpos de unión e inhibidores de ADAMTS-13 en respuesta a la PF diaria, con o sin administración complementaria de SHP655, durante el episodio agudo de PTT y hasta 30 días después de la resolución.
    3.Niveles de actividad de ADAMTS-13 en sujetos que reciben SHP655 adicional durante un máximo de 30 días después de la resolución del episodio de PTT.
    4.La relación entre la actividad de ADAMTS-13 y el estado de enfermedad del órgano diana (p. ej., enfermedades renales, neurológicas y cardíacas).
    5.Los parámetros de FC, como la recuperación incremental, el área bajo la curva, el aclaramiento inducido por anticuerpos y sistémico, la actividad máxima de ADAMTS-13 entre las PF o las infusiones de SHP655, y niveles mínimos de la PF.
    6.Incidencia de niveles mínimos > 10% de la actividad de ADAMTS-13.

    Criterios de valoración de la seguridad y la eficacia
    1.Tiempo hasta la normalización del recuento de plaquetas, que se define como un recuento de plaquetas ≥150 000/µl, que se debe confirmar con un segundo recuento normal de plaquetas de ≥150 000/µl y LDH <2 LSN en un plazo de 48 horas después de la normalización inicial.
    2.Aparición de remisión, que se define como un recuento normal de plaquetas y LDH <2 LSN durante un plazo mínimo de 48 horas después de la normalización inicial del recuento de plaquetas (periodo de episodio agudo).
    3.Tiempo hasta la primera exacerbación (episodio de PTTa ≤30 días después de la remisión).
    4.Tiempo hasta la recaída (episodio de PTTa >30 días después de la remisión).
    5.Incidencia de exacerbaciones.
    6.Incidencia de recaídas.
    7.Aparición de acontecimientos clínicos importantes relacionados con la PTT, como:
    a.Muerte b.Accidente cerebrovascular c.IM d.Disfunción orgánica no normalizada en el periodo de observación de 90 días i.Insuficiencia renal crónica ii.Deterioro neurológico iii.Deficiencias neurocognitivas
    8.Incidencia de acontecimientos clínicos importantes relacionados con la PF, como sangrado de importancia clínica (puntuación de TIP modificada) o trombosis en el lugar de la inserción de la vía, reacciones adversas al plasma, que incluyen reacciones al citrato, reacciones alérgicas y lesión pulmonar aguda producida por transfusión (TRALI).
    9.Cambios en el título de anticuerpos inhibidores y de unión de ADAMTS-13.
    10.Aparición de anticuerpos contra SHP655.
    11.Incidencia de AA y AAG y, concretamente, AA y AAG relacionados con el producto.
    12.Cambios relevantes clínicamente en constantes vitales, bioquímica clínica y hematología.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various time points throughout the study
    Varios puntos de tiempo a lo largo 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    Switzerland
    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
    Last Subject Last Visit
    Ultima visita Ultimo 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 months0
    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 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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 33
    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 treatment
    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 Decision2019-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-05
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