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    EudraCT Number:2017-004738-27
    Sponsor's Protocol Code Number:A011-09
    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:2018-09-05
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-004738-27
    A.3Full title of the trial
    A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
    Estudio de fase 2, doble ciego, controlado con placebo y aleatorizado para comparar la eficacia y la seguridad de sotatercept (ACE-011) frente al placebo cuando se añade al tratamiento estándar de la hipertensión arterial pulmonar (HAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of Sotatercept for the Treatment of PAH
    Estudio de fase 2 de Sotatercept para el tratamiento de HAP
    A.4.1Sponsor's protocol code numberA011-09
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03496207
    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 SponsorAcceleron Pharma 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 supportAcceleron Pharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcceleron Pharma Inc
    B.5.2Functional name of contact pointPeter Linde
    B.5.3 Address:
    B.5.3.1Street Address128 Sidney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    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 nameSotatercept
    D.3.2Product code ACE-011
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSOTATERCEPT
    D.3.9.1CAS number 1001080-50-7
    D.3.9.2Current sponsor codeACE-011
    D.3.9.3Other descriptive nameActRIIA-IgG1Fc
    D.3.9.4EV Substance CodeSUB179718
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary Arterial Hypertension (PAH)
    Hipertension Arterial Pulmonar (HAP)
    E.1.1.1Medical condition in easily understood language
    Cardiovascular Disease
    Enfermedad Cardiovascular
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077739
    E.1.2Term Pulmonary arterial hypertension WHO functional class I
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Treatment Period
    -To evaluate the effect on PVR in WHO functional class II-III PAH patients treated with sotatercept plus SOC compared with placebo plus SOC
    Extension Period
    -To evaluate the long-term safety of sotatercept in WHO functional class II-III PAH patients
    Período de tratamiento
    •Evaluar el efecto sobre la RVP en pacientes con HAP de clase funcional II-III de la OMS tratados con sotatercept más el TdR en comparación con un placebo más el TdR.
    Período de extensión
    •Evaluar la seguridad a largo plazo de sotatercept en pacientes con HAP de clase funcional II-III de la OMS.
    E.2.2Secondary objectives of the trial
    To assess the effects of sotatercept plus SOC on functional and pharmacodynamic endpoints in patients with PAH compared with placebo plus SOC
    Evaluar los efectos de sotatercept más el TdR sobre los resultados funcionales y farmacodinámicos en pacientes con HAP en comparación con un placebo más el TdR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must satisfy all of the following criteria to be enrolled in the study:
    1.Age ≥ 18 years
    2.Documented diagnostic right heart catheterization (RHC) at any time prior to Screening confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH in any of the following subtypes:
    Idiopathic or Heritable PAH
    Drug- or toxin-induced PAH
    PAH associated with connective tissue disease
    PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following shunt repair
    3.Symptomatic pulmonary hypertension classified as WHO functional class II or III
    4.Screening RHC documenting a minimum PVR of ≥ 400 dyn·sec/cm5 (5 Wood units)
    5.Pulmonary function tests (PFTs) within 6 months prior to Screening as follows:
    a.Total lung capacity (TLC) > 70% predicted; or if between 60-70% predicted, confirmatory high-resolution computed tomography indicating no more than mild interstitial lung disease (ILD)
    b.Forced expiratory volume (first second) (FEV1)/ forced vital capacity (FVC) > 70% predicted
    6.Ventilation-perfusion (VQ) scan (or, if unavailable a negative CT pulmonary angiogram [CTPA] result), any time prior to Screening with normal or low probability result
    7.No contraindication per investigator for RHC during the study
    8.6MWD ≥ 150 and ≤ 450 meters repeated twice at Screening and both values within 15% of each other, calculated from the highest value (see Appendix 4)
    9.PAH therapy at stable (per investigator) dose levels of SOC therapies as defined in Section 4.1 for at least 90 days prior to C1D1.
    10.Females of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 months), must:
    a.Have two negative pregnancy tests as verified by the investigator prior to starting study therapy (unless the screening pregnancy test was done within 72 hours of C1D1). She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment.
    b.If sexually active, agree to use, and be able to comply with, highly effective contraception** without interruption, 5 weeks prior to starting investigational product during the study therapy (including dose interruptions), and for 16 weeks after discontinuation of study treatment.
    c.Refrain from breastfeeding a child, donating blood, eggs, or ovum for the duration of the study and for at least 112 days after the last dose of study treatment.
    ** Highly effective contraception is defined in this protocol as the following (information will also appear in the ICF): Hormonal contraception (for example, birth control pills,injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation (having your tubes tied); or a partner with a vasectomy who has completed follow-up to confirm a successful procedure (see Appendix 6 for additional contraceptive information)
    Male participants must:
    a.Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (for example, polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 12 weeks following investigational product discontinuation, even if he has undergone a successful vasectomy. (see Appendix 6 for additional contraceptive information).
    b.Refrain from donating blood or sperm for the duration of the study and for 112 days after the last dose of study treatment.
    Para poder incorporarse al estudio, los participantes deberán cumplir todos los criterios siguientes:
    1.Edad ≥ 18 años.
    2.Cateterismo cardíaco derecho (CCD) documentado, realizado con fines diagnósticos en cualquier momento antes de la selección y que confirme el diagnóstico de hipertensión pulmonar del grupo I de la OMS: Cualquiera de los siguientes tipos de HAP:
    HAP idiopática o hereditaria
    HAP inducida por drogas o toxinas
    HAP asociada a enfermedad del tejido conjuntivo
    HAP asociada a cortocircuitos sistémico-pulmonares simples congénitos al menos 1 año después de la reparación del cortocircuito.
    3.Hipertensión pulmonar sintomática clasificada dentro de la clase funcional II o III de la OMS.
    4.CCD en la selección que documente una RVP mínima de ≥ 400 din·s/cm5 (5 unidades Wood)
    5.Pruebas de función pulmonar (PFP) en los 6 meses previos a la selección como sigue:
    a.Capacidad pulmonar total (TLC) > 70% del valor previsto; o, si está entre el 60% y el 70% del valor previsto, tomografía computarizada de alta resolución que confirme la presencia de no más que enfermedad pulmonar intersticial (EPI) leve.
    b.Volumen espiratorio forzado (primer segundo) (FEV1)/ capacidad vital forzada (FVC) > 70% del valor previsto.
    6.Gammagrafía de ventilación-perfusión (VQ) (o, si no se dispone de ella, resultado negativo en la angiografía pulmonar mediante TC [APTC]) realizada en algún momento antes de la selección con un resultado de probabilidad normal o bajo.
    7.Ausencia de contraindicaciones para el CCD durante el estudio, según lo determinado por el investigador.
    8.Valores de la PM6M ≥ 150 y ≤ 450 metros repetidos dos veces en la selección y diferencia entre ambos valores inferior al 15%, calculada a partir del valor más alto (véase el Apéndice 4)
    9.Tratamiento de la HAP con dosis estables (según el investigador) de tratamientos de referencia, según se definen en la sección 4.1, desde por lo menos 90 días antes del D1C1.
    10.Las mujeres en edad fértil, definidas como mujeres sexualmente maduras que: 1) no se hayan sometido a una histerectomía u ovariectomía bilateral, o 2) no hayan llegado a la menopausia natural (la amenorrea tras el tratamiento del cáncer no descarta la posibilidad de concebir) durante al menos 24 meses consecutivos (es decir, hayan tenido la menstruación en algún momento de los 24 meses consecutivos previos), tendrán que:
    a. Haber obtenido un resultado negativo en dos pruebas de embarazo, según lo verificado por el investigador antes de iniciar el tratamiento del estudio (a menos que la prueba de embarazo en la selección se haya realizado en las 72 horas previas al D1C1). Acceder a someterse a pruebas de embarazo periódicamente durante el estudio y después de finalizar el tratamiento del estudio.
    b. En caso de ser sexualmente activas, comprometerse a utilizar y ser capaces de cumplir con el uso de métodos anticonceptivos muy eficaces** sin interrupción, desde 5 semanas antes del inicio del producto en investigación, durante el tratamiento del estudio (incluidas las interrupciones de la administración) y hasta 16 semanas después de la suspensión del tratamiento del estudio.
    c. Abstenerse de dar el pecho y donar sangre y ovulos durante todo el estudio y durante al menos 112 dias despues de la ultima dosis del tratamiento del estudio.
    ** En este protocolo se define un método anticonceptivo muy eficaz como sigue (esta información se incluirá también en el DCI): Anticonceptivos hormonales (por ejemplo, anticonceptivos orales, inyección, implante, parche transdérmico, anillo vaginal); dispositivo intrauterino (DIU); ligadura de trompas); o pareja con vasectomía que haya sido objeto de seguimiento para confirmar el éxito del procedimiento (véase en el apéndice 6 información adicional sobre los anticonceptivos)
    Los participantes varones tendrán que:
    a. Comprometerse a utilizar un preservativo, definido como un preservativo masculino de látex o de otro material que NO esté fabricado con membranas naturales [de origen animal], por ejemplo, de poliuretano) cuando mantengan relaciones sexuales con mujeres embarazadas o con capacidad para procrear mientras participen en el estudio, durante las interrupciones del tratamiento y hasta por lo menos 12 semanas después de la suspensión del producto en investigación, incluso aunque se hayan sometido a una vasectomía con éxito.
    b. No donar sangre o esperma mientras participe en este estudio y en los 112 días siguientes a la última dosis de la medicación del estudio
    E.4Principal exclusion criteria
    Participants will be excluded from the study if they meet any of the following criteria:
    1. Stopped receiving any pulmonary hypertension chronic general supportive therapy (e.g,diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to C1D1
    2. Received intravenous inotropes (e.g.,dobutamine, dopamine, norepinephrine, vasopressin) within 30days prior to C1D1
    3. History of atrial septostomy within 180days prior to Screening;
    4. History of more than mild obstructive sleep apnea that is untreated
    5. Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C);
    6. History of human immunodeficiency virus infection-associated PAH;
    7. Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536);
    8. Initiation of an exercise program for cardiopulmonary rehabilitation within 90days prior to C1D1 or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible);
    9. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) >160mm Hg or sitting diastolic blood pressure >100mm Hg during Screening after a period of rest
    10. Systolic BP <90mmHg during Screening or at baseline;
    11. History of known pericardial constriction;
    12. ECG with QTcF >480 sec during Screening Period or C1D1;
    13. History of personal or family history of long QTc syndrome or sudden cardiac death;
    14. History of recent cerebrovascular accident (CVA) within 3months of C1D1;
    15. History of restrictive or congestive cardiomyopathy;
    16. Left ventricular ejection fraction (LVEF) <45% on historical echocardiogram (ECHO) within 6 months prior to Screening or pulmonary capillary wedge pressure (PCWP) >15mmHg on right heart catheterization during baseline evaluation;
    17. Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain);
    18. Acutely decompensated heart failure within 30days prior to C1D1, as per investigator assessment;
    19. Significant (≥2+ regurgitation) mitral regurgitation (MR) or aortic regurgitation (AR) valvular disease;
    20. Any of the following clinical laboratory values during the Screening Period prior to C1D1:
    a. Baseline Hgb >15.0g/dL for women; >16.0g/dL for men within 28 days of C1D1;
    b. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >3X upper limit of normal (ULN) or total bilirubin >1.5X ULN within 28 days of C1D1;
    c. White blood cell (WBC) count <4000/mm3;
    d. Platelets < 100,000/µL;
    e. Absolute neutrophil count (ANC) <1500/mm3
    21. History of opportunistic infection (e.g.,invasive candidiasis or pneumocystis pneumonia) within 6months prior to Screening; serious local infection (e.g.,cellulitis, abscess) or systemic infection (e.g.,septicemia) within 3months prior to Screening;
    22. History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product;
    23. Major surgery within 8weeks prior to randomization. Participants must have completely recovered from any previous surgery prior to randomization;
    24. Prior heart or heart-lung transplants, active on the lung transplant list, or life expectancy of <12months;
    25. Weight >140 kg at screening;
    31. History of renal disease, including:
    a.Chronic renal disease at any time prior to screening; or
    b.Any episode of acute renal failure, with or without a prior history of renal disease, occurring within 3months prior to screening in which acute dialysis (e.g.,intermittent hemodialysis or continuous veno-venous hemofiltration) was required
    Se excluirá de este estudio a los participantes que cumplan alguno de los criterios siguientes:
    1. Interrupción de cualquier tratamiento complementario general crónico para la hipertensión pulmonar (p. ej., diuréticos, oxígeno, anticoagulantes, digoxina) en los 60 días previos al D1C1
    2. Administración de un tratamiento intravenoso con inotropos (p. ej., dobutamina, dopamina, noradrenalina, vasopresina) en los 30 días previos al D1C1
    3. Antecedentes de septostomía auricular en los 180 días previos a la selección.
    4. Antecedentes de apnea obstructiva del sueño más que leve que no ha sido tratada.
    5. Antecedentes conocidos de hipertensión portal o hepatopatía crónica, como hepatitis B o C (con signos de infección reciente o replicación activa del virus), definida como insuficiencia hepática leve o grave (clase A-C de Child-Pugh).
    6. Antecedentes de HAP asociada a infección por el virus de la inmunodeficiencia humana.
    7. Exposición previa a sotatercept (ACE-011) o luspatercept (ACE-536)
    8. Inicio de un programa de ejercicio físico para rehabilitación cardiopulmonar en los 90 días previos al D1C1 o inicio previsto durante el estudio (podrán incorporarse al estudio participantes que se encuentren estables en la fase de mantenimiento de un programa de este tipo y que lo mantengan durante todo el estudio).
    9. Hipertensión sistémica no controlada, demostrada por una presión arterial sistólica (PA) en sedestación > 160 mm Hg o una presión arterial diastólica en sedestación > 100 mm Hg durante la selección después de un período de reposo.
    10. PA sistólica < 90 mmHg durante la selección o en el momento basal.
    11. Antecedentes de constricción pericárdica conocida
    12. ECG con QTcF > 480 ms durante el período de selección o el D1C1.
    13. Antecedentes personales o familiares de síndrome del intervalo QTc prolongado o muerte súbita de origen cardíaco.
    14. Antecedentes de accidente cerebrovascular (ACV) reciente en los 3 meses previos al D1C1.
    15. Antecedentes de miocardiopatía restrictiva o congestiva.
    16. Fracción de eyección del ventrículo izquierdo (FEVI) < 45% en el ecocardiograma (ECO) o presión de enclavamiento capilar pulmonar (PECP) > 15 mmHg en el cateterismo cardíaco derecho durante la evaluación basal.
    17. Presencia o antecedentes de cualquier enfermedad coronaria sintomática (infarto de miocardio previo, intervención coronaria percutánea, injerto de derivación aortocoronaria o dolor torácico cardiaco anginoso)
    18. Insuficiencia cardíaca descompensada aguda en los 30 días previos al D1C1, según la evaluación del investigador.
    19. Enfermedad valvular por insuficiencia mitral (IM) o insuficiencia aórtica (IA) significativa (reflujo ≥ 2+).
    20. Cualquiera de los siguientes valores analíticos durante el período de selección antes del D1C1:
    a. Hb basal > 15,0 g/dl en las mujeres; > 16,0 g/dl en los varones en los 28 días previos al D1C1.
    b. Concentración sérica de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 3 veces el límite superior de la normalidad (LSN) o bilirrubina total > 1,5 veces el LSN en los 28 días previos al D1C1.
    c. Filtración glomerular estimada (FGe) < 30 ml/min/1,73 m2 (ecuación MDRD de 4 variables) en los 28 días previos al D1C1 o necesidad de tratamiento renal sustitutivo en los 90 días previos.
    21. Antecedentes de infección oportunista (por ejemplo, candidiasis invasora o neumonía por Pneumocystis) en los 6 meses previos a la selección; infección local grave (por ejemplo, celulitis, absceso) o infección sistémica (por ejemplo, septicemia) en los 3 meses previos a la selección.
    22. Antecedentes de reacción alérgica o anafiláctica intensa o hipersensibilidad conocida a proteínas recombinantes o excipientes del producto en investigación (véase el Manual del investigador).
    23. Operación quirúrgica importante en las 8 semanas previas a la aleatorización. Los participantes deberán haberse recuperado totalmente de cualquier intervención previa a la aleatorización
    24. Trasplante previo de corazón o corazón-pulmón, en espera de un trasplante pulmonar o esperanza de vida < 12 meses
    25. Peso >140 kg en selección;
    31. Antecedentes enfermedad renal, que incluye:
    a) Enfermedad renal crónica antes selección; o
    b) Cualquier episodio insuficiencia renal aguda, con o sin antecedentes enfermedad renal, producido 3meses previos selección que precisara diálisis aguda (ej., hemodiálisis intermitente o hemofiltración venovenosa continua)
    E.5 End points
    E.5.1Primary end point(s)
    Treatment Period
    -Change in PVR
    Extension Period
    -Presence and nature of AEs and changes in clinical laboratory parameters
    Período de tratamiento
    •Variación de la RVP Período de extensión
    •Presencia y naturaleza de los AA y variaciones de los parámetros analíticos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Period
    -At 24 weeks vs baseline
    Extension Period
    -During the extension period
    Período de tratamiento
    •A las 24 semanas con respecto al momento basal.
    Período de extensión
    •Durante el perido de extension.
    E.5.2Secondary end point(s)
    Key Secondary Endpoint
    -Change in 6MWD
    Other Secondary Endpoints:
    -Change in NT-proBNP
    -Change in TAPSE
    Criterio de valoración secundario fundamental
    •Variación en la 6MWD
    Otros criterios de valoración secundarios:
    •Variación del NT-proBNP
    •Variación del TAPSE
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key Secondary Endpoint
    -At 24 weeks vs baseline
    Other Secondary Endpoints:
    -At 24 weeks vs baseline
    -At 24 weeks vs baseline
    Criterio de valoración secundario fundamental
    •A las 24 semanas con respecto al momento basal.
    Otros criterios de valoración secundarios:
    •A las 24 semanas con respecto al momento basal.
    •A las 24 semanas con respecto al momento basal.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    United Kingdom
    United States
    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
    Ultima visita Ultimo paciente (UVUP)
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 90
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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)
    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 Decision2018-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
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