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    Summary
    EudraCT Number:2017-000212-41
    Sponsor's Protocol Code Number:206246
    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:2017-06-22
    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 number2017-000212-41
    A.3Full title of the trial
    An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension.
    Estudio abierto, de escalada de dosis para evaluar la seguridad, tolerancia, farmacocinética y farmacodinamia de dosis únicas de GSK2586881 en pacientes con hipertensión arterial pulmonar.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH).
    Estudio para evaluar un nuevo fármacoen participantes con hipertensión arterial pulmonar (HAP).
    A.3.2Name or abbreviated title of the trial where available
    PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts
    A.4.1Sponsor's protocol code number206246
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline R&D
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number34902202700
    B.5.5Fax number34918070479
    B.5.6E-mailes-ci@gsk.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 nameGSK2586881
    D.3.2Product code GSK2586881
    D.3.4Pharmaceutical form 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 INNGSK2586881
    D.3.9.2Current sponsor codeGSK2586881
    D.3.9.3Other descriptive nameRecombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01
    D.3.9.4EV Substance CodeSUB83581
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary arterial hypertension
    Hipertensión arterial pulmonar.
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension
    Hipertensión arterial pulmonar
    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 PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077729
    E.1.2Term Pulmonary arterial hypertension WHO functional class III
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077740
    E.1.2Term Pulmonary arterial hypertension WHO functional class II
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate changes in the pulmonary hemodynamics after single IV doses of GSK2586881 administered to participants with PAH receiving background PAH therapy.
    Evaluar los cambios en la hemodinámica pulmonar tras una única dosis i.v. de GSK2586881 administrada a los participantes con HAP que reciben un tratamiento de base para HAP.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of single IV doses of GSK2586881 administered to participants with PAH receiving background PAH therapy.
    -To evaluate the effect of single IV doses of GSK2586881 on RAS peptide responses in participants with PAH receiving background PAH therapy.
    -To evaluate the effect on biomarkers of disease activity after single IV doses of GSK2586881 administered to participants with PAH receiving background PAH therapy.
    -To evaluate the pharmacokinetics of GSK2586881 after single IV doses of GSK2586881 in participants with PAH receiving background PAH therapy.
    - Evaluar la seguridad y tolerabilidad de una única dosis i.v. de GSK2586881 administrada a los participantes con HAP que reciben un tratamiento de base para HAP.
    - Evaluar el efecto de una única dosis i.v. de GSK2586881 sobre las respuestas de los péptidos del RAS en los participantes con HAP que reciben un tratamiento de base para HAP.
    - Evaluar el efecto sobre los biomarcadores de la actividad de la enfermedad tras una única dosis i.v. de GSK2586881 administrada a los participantes con HAP que reciben un tratamiento de base para HAP.
    - Evaluar la farmacocinética (FC) de GSK2586881 tras una única dosis i.v. de GSK2586881 en los participantes con HAP que reciben un tratamiento de base para HAP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age
    1. Participant must be between 18-75 years of age (inclusive), at the time of signing the informed consent
    Type of Participant and Disease Characteristics
    2. Documented diagnosis of PAH, defined as mPAP > 25 mmHg and PWP ≤ 15 mmHg.
    3. IPAH, HPAH, or PAH associated with collagen vascular disease, repaired congenital heart disease, or appetite suppressant use.
    - Note: Those with portopulmonary hypertension or PVOD are not eligible for the study
    4. World Health Organization (WHO) functional class I, II, or III, stable for at least 8 weeks prior to enrollment.
    5. Hemodynamically stable on background therapy without evidence of right heart failure (historic data).
    6. Six minute walk (6MW) distance, as performed at screening or within 6 months prior to screening, of > 100 meters
    7. Mean BP of >60 mmHg
    8. Receiving stable doses of one or more medications that are approved for treatment of PAH, including endothelin receptor antagonists, phosphodiesterase 5 inhibitors, and/or prostanoids/prostacyclin receptor agonists, for a minimum of 12 consecutive weeks before enrollment.
    NOTE: Anticoagulant therapy can be adjusted according to target INR
    9. Diuretic dose stable for 8 weeks.
    Weight
    10. Body weight <90 kg and body mass index (BMI) within the range 18-30 kg/m2 (inclusive).
    Sex
    11. Male and/or female (following confirmation of negative pregnancy test for WOCBP). Women who are pregnant or breastfeeding are excluded.
    Informed Consent
    12. Capable of giving signed informed consent as described in Appendix 3 (within the protocol) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
    Edad
    1. Los participantes deben tener entre 18 y 75 años (ambos inclusive) en el momento de la firma del consentimiento informado.
    Tipo de participantes y características de la enfermedad
    2. Diagnóstico documentado de HAP, que se define como PAPm >25 mmHg y PEP <=15 mmHg.
    3. HAPI, HAPH o HAP asociada a enfermedad del tejido conectivo, cardiopatía congénita reparada o uso de supresores del apetito.
    Nota: Aquellos con hipertensión portopulmonar o EVOP no son elegibles para el estudio.
    4. Clase funcional I, II o III según la Organización Mundial de la Salud (OMS), estable durante un mínimo de 8 semanas antes de la inclusión.
    5. Hemodinámicamente estable con tratamiento de base sin indicios de insuficiencia cardiaca derecha (datos históricos).
    6. Distancia en el test de la marcha de los 6 minutos (TM6M) de >100 metros, en la selección o en los 6 meses previos a la selección.
    7. PA media >60 mmHg
    8. Tratamiento con dosis estables de uno o más fármacos autorizados para la HAP, incluyendo antagonistas del receptor de endotelina, inhibidores de la fosfodiesterasa 5 y/o agonistas del receptor de prostanoides/prostaciclinas, durante un mínimo de 12 semanas consecutivas antes de la inclusión.
    NOTA: La terapia con anticoagulantes se puede ajustar conforme al objetivo INR.
    9. Dosis de diurético estable durante 8 semanas.
    Peso
    10. Peso corporal <90 kg e índice de masa corporal (IMC) entre 18 y 30 kg/m2 (ambos inclusive).
    Sexo
    11. Varón y/o mujer (tras confirmación con una prueba de embarazo negativa en MEF). Se excluirán las mujeres embarazadas o en periodo de lactancia.
    Consentimiento informado
    12. Con capacidad para otorgar el consentimiento informado firmado, tal y como se describe en el Apéndice 3, lo que incluye el cumplimiento con los requisitos y restricciones dispuestas en el CI y en este protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. History of systemic hypotension, defined as systolic BP <90 mmHg and/or diastolic BP <50 mmHg.
    2. Hospitalization for PAH associated deterioration in the previous 6 months.
    3. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities.
    Concurrent disease or condition that may interfere with study participation or safety include bleeding disorders, arrhythmia, organ transplant, organ failure, current neoplasm, poorly controlled diabetes mellitus, and serious neurological disorders.
    4. Complex unrepaired congenital heart disease.
    5. Subjects with Eisenmenger physiology.
    6. Alanine transferase (ALT) >2x upper limit of normal (ULN).
    7. Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    8. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    9. Estimated glomerular-filtration-rate (eGFR) <60mL/min/1.73m2.
    10. QTc >480 msec or QTc > 500 msec in participants with bundle branch block.
    NOTES:
    -The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method. It is either machineread or manually over-read.
    -The specific formula used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulas cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial.
    11. Any bleeding concerns as evidenced by INR >1.5 (in participants not receiving anticoagulation therapy) or platelet count <80,000.
    12. Hb <10 g/dL
    Prior/Concomitant Therapy
    13. Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates participation in the study.
    14. Any use of an ACE inhibitor or angiotensin receptor blocker within 14 days prior to dosing. Therapy can be stopped to enable inclusion if deemed safe by the participant’s treating physician.
    Prior/Concurrent Clinical Study Experience
    15. Use of any investigational product (IP) or device within 30 days prior to dosing, or known requirement for any investigational agent prior to completion of all scheduled study assessments.
    Diagnostic assessments
    16. Positive HIV antibody test.
    17. Presence of Hepatitis B surface antigen (HBsAg) at screening.
    18. Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study treatment.
    -NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.
    19. Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
    -NOTE: Test is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
    Other Exclusions
    20. Participation in the study would result in loss of blood or blood products in excess of 300mL within 65 days.
    21. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
    22. A known or suspected history of alcohol or drug abuse within the 2 years prior to screening
    23. Unable to refrain from smoking during the in-house treatment period.
    Los participantes se excluirán del estudio si cumplen cualquiera de los siguientes criterios:
    Afecciones médicas
    1. Antecedentes de hipotensión sistémica, definida como PA sistólica <90 mmHg y/o PA diastólica <50 mmHg.
    2. Hospitalización por HAP asociada a deterioro en los 6 meses previos.
    3. Cualquier afección médica adicional, enfermedad intercurrente grave u otra circunstancia extenuante que, en opinión del investigador, pueda interferir de manera significativa con el cumplimiento del estudio, incluyendo todas las evaluaciones prescritas y actividades de seguimiento. Entre las enfermedades concurrentes o afecciones que pueden interferir con la participación en el estudio o la seguridad se incluyen: trastornos hemorrágicos, arritmia, trasplante de órganos, fallo orgánico, neoplasia actual, diabetes mellitus mal controlada, y trastornos neurológicos graves.
    4. Cardiopatía congénita compleja no reparada
    5. Sujetos con síndrome de Eisenmenger.
    6. Alanina transferasa (ALT) >2 x límite superior del normal (LSN).
    7. Bilirrubina >1,5 x LSN (se permite bilirrubina aislada >1,5 x LSN si se realiza el fraccionamiento de la bilirrubina, y la bilirrubina directa <35%).
    8. Antecedentes o presencia de hepatopatía crónica o anomalías hepáticas o biliares conocidas (con la excepción del síndrome de Gilbert o cálculos biliares asintomáticos).
    9. Tasa de filtración glomerular estimada (TFGe) <60 mL/min/1,73 m2.
    10. QTc >480 mseg o QTc >500 mseg en participantes con bloqueo de rama.
    NOTAS: QTc es el intervalo QT corregido por la frecuencia cardiaca según la fórmula de Bazett (QTcB), fórmula de Fridericia (QTcF) y/u otro método. Se determina con una lectura del aparato o manual.
    La fórmula específica que se utilizará para determinar la elegibilidad y la retirada de cada sujeto se establecerá antes del inicio del estudio. En otras palabras, no se pueden utilizar varias fórmulas diferentes para calcular el QTc de cada participante, y después utilizar el valor de QTc más bajo para incluir o retirar a un participante del ensayo.
    11. Cualquier problema hemorrágico evidenciado por un INR >1,5 (en participantes que no reciben terapia anticoagulante) o recuento plaquetario <80.000.
    12. Hb <10 g/dL.
    Tratamiento previo/concomitante
    13. Sensibilidad a cualquiera de los tratamientos del estudio o a sus componentes o fármacos u otras alergias que, en opinión del investigador o Monitor Médico, contraindican la participación en el estudio.
    14. Cualquier uso de un inhibidor de la ECA o antagonista del receptor de la angiotensina en los 14 días previos a la administración. El tratamiento se puede interrumpir para permitir la inclusión si el médico del participante lo considera seguro.
    Experiencia del estudio clínico actual/previo
    15. Uso de cualquier producto en investigación (PI) o dispositivo en los 30 días previos a la administración, o requisito conocido para cualquier agente en investigación con anterioridad a la finalización de todas las evaluaciones del estudio programadas.
    Evaluaciones diagnósticas
    16. Prueba de anticuerpos de VIH positiva.
    17. Presencia de antígenos de superficie del virus de hepatitis B (AgHB) en la selección.
    18. Resultado positivo en la prueba de anticuerpos de hepatitis C en la selección o en los 3 meses previos al inicio del tratamiento del estudio.
    NOTA: Se pueden incluir participantes con un resultado positivo para anticuerpos de hepatitis C debido a una enfermedad previa resuelta, solo si se obtiene un resultado negativo en la prueba confirmatoria de ácido ribonucleico (ARN) de hepatitis C.
    19. Resultado positivo en la prueba de ARN de hepatitis C en la selección o en los 3 meses previos a la primera dosis del tratamiento del estudio.
    NOTA: La prueba es opcional y los participantes con un resultado negativo en la prueba de anticuerpos de hepatitis C no necesitan someterse a análisis del ARN de hepatitis C.
    Otras exclusiones
    20. La participación en el estudio dará lugar a una pérdida de sangre o hemoderivados en exceso de 300 mL en 65 días.
    21. Exposición a más de 4 entidades químicas nuevas en los 12 meses previos al primer día de administración.
    22. Antecedentes conocidos o sospecha de consumo de bebidas alcohólicas o abuso de drogas en los 2 años previos a la selección.
    23. Incapacidad de abstenerse de fumar durante el periodo de tratamiento en el hospital.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from baseline in pulmonary vascular resistance (PVR), cardiac output (CO) and mean pulmonary artery pressure (mPAP), as data permit
    Cambios frente al valor basal en la resistencia vascular pulmonar (RVP), gasto cardiaco (GC) y presión arterial pulmonar media (PAPm), según lo permitan los datos
    E.5.1.1Timepoint(s) of evaluation of this end point
    0, 1h, 2h, 4h
    0, 1h, 2h, 4h
    E.5.2Secondary end point(s)
    -Adverse events (AE), clinical laboratory values, vital signs, ECG, pulse oximetry and immunogenicity.
    -Change from baseline of RAS peptides (e.g. Ang II, Ang(1-7), Ang(1-5),
    transpulmonary gradient of AngII/Ang (1-7) ratio).
    -Change from baseline in NT pro-BNP, NO and cardiac troponin I.
    -Plasma concentrations of GSK2586881 and derived PK parameters.
    - Acontecimientos adversos (AA), valores analíticos clínicos, signos vitales, electrocardiogramas (ECG), pulsioximetría e inmunogenicidad.
    - Cambios frente al valor basal de los péptidos del RAS (p. ej., Ang II, Ang(1-7), Ang(1-5), gradiente transpulmonar de la relación Ang II/Ang(1-7)).
    - Cambios frente al valor basal en pro-BNP-NT, NO y troponina cardiaca I.
    - Concentraciones plasmáticas de GSK2586881 y parámetros FC derivados.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • 0.08h
    • 0.5h
    • 1h
    • 2h
    • 4h
    • 8h
    • 24h
    • 7-14 days after dose,
    • immunogenicity also collected at 28 +/- 3 days after dose
    • 0.08h
    • 0.5h
    • 1h
    • 2h
    • 4h
    • 8h
    • 24h
    • 7-14 días despues de la dosis,
    • inmunogenicidad también recogida a los 28 +/- 3 días después de la dosis
    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 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 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
    LVLS
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 21
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    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)
    Participants will not receive any additional treatment from GSK after completion of the study because other treatment options are available.
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the participants medical condition, whether or not GSK is providing specific post-study treatment
    Los participantes no recibirán tratamiento adicional de GSK tras completar el estudio ya que hay otras opciones de tratamiento disponibles
    El investigador es el responsable de asegurar que tras el estudio se ha tenido en cuenta el tratamiento de la condición médica de los participantes, independientemente de que GSK esté proporcionando o no el tratamiento específico post-estudio.
    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 Decision2017-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-07
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