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    Summary
    EudraCT Number:2015-004790-32
    Sponsor's Protocol Code Number:204836
    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:2016-01-13
    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 number2015-004790-32
    A.3Full title of the trial
    A 29-day, randomized, double-blinded, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy, safety and pharmacokinetics of three-times weekly dosing of GSK1278863 in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who are switched from a stable dose of an erythropoiesis-stimulating agent.
    Estudio multicéntrico, de grupos paralelos, controlado con placebo, doble ciego, aleatorizado, de 29 días para evaluar la eficacia, la seguridad y la farmacocinética de la administración tres veces a la semana de GSK1278863 en sujetos dependientes de hemodiálisis con anemia asociada a nefropatía crónica que recibían una dosis estable de un fármaco estimulante de la eritropoyesis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test three times weekly dosing of GSK1278863 in the treatment of anemia associated with chronic kidney disease in hemodialysis patients.
    Estudio para probar la administración de 3 veces a la semana de GSK1278863 en el tratamiento de anemia asociada a nefropatía crónica en sujetos dependientes de hemodiálisis
    A.4.1Sponsor's protocol code number204836
    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 Research and Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGSK
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34 900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameGSK1278863
    D.3.2Product code GSK1278863
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGSK1278863
    D.3.9.2Current sponsor codeGSK1278863
    D.3.9.3Other descriptive nameGSK1278863
    D.3.9.4EV Substance CodeSUB72830
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGSK1278863
    D.3.9.2Current sponsor codeGSK1278863
    D.3.9.3Other descriptive nameGSK1278863
    D.3.9.4EV Substance CodeSUB72830
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemia associated with chronic kidney disease
    Anemia asociada con nefropatía crónica
    E.1.1.1Medical condition in easily understood language
    Anemia associated with chronic kidney disease
    Anemia asociada con nefropatía crónica
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10002272
    E.1.2Term Anemia
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Characterize the dose-response relationship between GSK1278863 administered threetimes weekly and Hgb at Day 29.
    -Caracterizar la relación dosis-respuesta entre GSK1278863 administrado tres veces a la semana y Hgb el día 29
    E.2.2Secondary objectives of the trial
    -Characterize the pharmacodynamic (PD) effect of GSK1278863 dose regimens on EPO, vascular endothelial growth factor (VEGF), hepcidin and red blood cells.
    -Characterize the steady-state PK of GSK1278863 and major metabolites.
    - Assess the safety and tolerability of GSK1278863 with three-times weekly administration for 29 days.
    -Caracterizar el efecto farmacodinámico (FD) de los regímenes posológicos de GSK1278863 en la EPO, el factor de crecimiento endotelial vascular (VEGF), la hepcidina y los eritrocitos
    -Caracterizar la FC en estado de equilibrio de GSK1278863 y los metabolitos principales
    -Evaluar la seguridad y tolerabilidad de GSK1278863 administrado tres veces a la semana durante 29 días
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    AGE
    1. >=18 years of age, at the time of signing the informed consent.
    TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
    2. Hemoglobin: Stable Hgb 9.0 - 11.5 g/dL (see Section 5.1 of study protocol).
    3. Dialysis frequency: On hemodialysis (HD, hemofiltration or hemodiafiltration) three to five times weekly for at least 4 weeks prior to Day -28 Screening through Day 29.
    4. Dialysis adequacy: A single pool Kt/Vurea of ? 1.2 based on a historical value obtained within the prior three months in order to ensure the adequacy of dialysis. If Kt/Vurea is not available, then an average of the last 2 values of urea reduction ratio (URR) of at least 65%. NOTE: Only needs confirming at Day -28.
    5. ESA dose: Treated with the same ESA (epoetins or their biosimilars, or darbepoetin or methoxy PEG-epoetin beta) with total weekly dose varying by no more than 50% during the 4 weeks prior to Day -28.
    6. Iron replacement therapy: Subjects may be on stable maintenance oral or IV (?100mg/week) iron supplementation. If subjects are on oral or IV iron, then doses must be stable for the 4 weeks prior to Day -28, during the screening phase, and through the 29 days of treatment.
    INFORMED CONSENT
    7. Capable of giving signed informed consent as described in Section 10.2 of study ptotocol which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
    Solo podrán participar en este estudio los sujetos que cumplan todos los criterios siguientes:
    EDAD
    1.Edad mínima de 18 años en el momento de firmar el documento de consentimiento informado
    TIPO DE SUJETO Y DIAGNÓSTICO, INCLUIDA LA GRAVEDAD DE LA ENFERMEDAD
    2.Hemoglobina: Valor estable de Hgb entre 9,0 y 11,5 g/dl (véase la sección 5.1)
    3.Frecuencia de diálisis: Dependiente de hemodiálisis (HD, hemofiltración o hemodiafiltración) entre tres y cinco veces a la semana desde al menos 4 semanas antes del día -28 de la selección hasta el día 29.
    4.Idoneidad de la diálisis: Un único cociente agregado Kt/Vurea de ?1,2 basado en un valor histórico obtenido en los tres meses previos para confirmar la idoneidad de la diálisis. Si no se dispone del cociente Kt/Vurea, una media de los dos últimos valores del cociente de reducción de la urea (CRU) de al menos el 65%. NOTA: Solo necesita confirmación el día -28.
    5.Dosis de FEE: Tratado con el mismo FEE (epoetinas o sus biosimilares, o darbepoetina o metoxi PEG-epoetina beta) con una dosis semanal total que varía no más del 50% durante las 4 semanas previas al día -28.
    6.Tratamiento de reposición de hierro: Los sujetos pueden estar recibiendo un tratamiento de mantenimiento estable con suplementos de hierro por vía oral o IV (?100 mg/semana). Si los sujetos están recibiendo hierro por vía oral o IV, las dosis deberán mantenerse estables en las 4 semanas previas al día -28, durante la fase de selección y hasta el día 29 de tratamiento.
    CONSENTIMIENTO INFORMADO
    7.Capacidad para otorgar el consentimiento informado firmado según se describe en la sección 10.2, lo que incluye el cumplimiento de los requisitos y restricciones que se recogen en el documento de consentimiento y en este protocolo.
    E.4Principal exclusion criteria
    CKD-RELATED CRITERIA
    1. Dialysis modality: Planned change from HD to peritoneal dialysis within the study time period.
    2. Renal transplant: Planned for living-related kidney transplant.
    3. High ESA dose: An epoetin dose of >=360 IU/kg/week IV or >=250 IU/kg/week subcutaneous (SC) or darbepoetin dose of >=1.8 µg /kg/week IV or SC or methoxy PEG-epoetin beta dose of 2.2 µg /kg/week within the prior 8 weeks through Day 1 (randomization).
    4. Mircera: Administration of Mircera (methoxy PEG-epoetin beta) within the prior 4 weeks through Day 1 (randomization).
    CARDIOVASCULAR DISEASE-RELATED CRITERIA
    5. Myocardial infarction or acute coronary syndrome: Within the 8 weeks prior to Screening through Day 1 (randomization).
    6. Stroke or transient ischemic attack: Within 8 weeks prior to Screening though Day 1 (randomization).
    7. Heart failure: Class IV heart failure, as defined by the New York Heart Association functional classification system diagnosed prior to Screening through Day 1 (randomization).
    8. QTcB: QTcB >500 msec or QTcB >530 msec in subjects with Bundle Branch Block. There is no QTc exclusion for subjects with a predominantly paced rhythm.
    OTHER DISEASE-RELATED CRITERIA
    9. Inflammatory disease: Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) diagnosed prior to Screening through Day 1 (randomization).
    10. Hematological disease: Any hematological disease including those affecting platelets, white or red blood cells (e.g., sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia and thalassemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other cause of anemia of chronic disease other than renal disease diagnosed prior to Screening though Day 1 (randomization).
    11. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert?s syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests [alanine transaminase (ALT) or aspartate transaminase (AST) >2x upper limit of normal (ULN) or total bilirubin >1.5xULN]; or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participating in the study.
    NOTE: Those with Hepatitis B or Hepatitis C are eligible provided these exclusions are not met.
    12. Major surgery: Major surgery (excluding vascular access surgery) within the 8 weeks prior to Screening, during the Screening phase, or planned during the study.
    13. Transfusion: Blood transfusion within the 8 weeks prior to Screening, during the Screening phase or an anticipated need for blood transfusion during the study.
    14. GI Bleeding: Evidence of actively bleeding peptic, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within the 8 weeks prior to Screening through Day 1 (randomization).
    15. Acute Infection: Clinical evidence of acute infection or history of infection requiring intravenous (IV) antibiotic therapy within the 4 weeks prior to Screening through Day 1 (randomization).
    16. Malignancy: History of malignancy within the two years prior to randomization or currently receiving treatment for cancer, or has a known > 4 cm complex kidney cyst (i.e. Bosniak Category II F, III of IV).
    CONCOMITANT MEDICATIONS
    17. Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product
    18. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from Screening until the Follow-up Visit.
    19. Prior investigational product exposure: The Subject has participated in a clinical trial and has received an experimental investigational product within the prior 30 days from Screening through Day 1 (randomization).
    GENERAL HEALTH RELATED CRITERIA
    20. Other conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.
    21. Females ONLY: Does not meet the female eligibility criteria (See Section 12.6 Appendix 6 of study protocol)
    DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
    22. Vitamin B12: At or below the lower limit of the reference range (may rescreen in a minimum of 8 weeks).
    23. Folate: <2.0 ng/mL (4.5 nmol/L) (may rescreen in a minimum of 4 weeks).
    24. Ferritin: <100 ng/mL ((<100 µg/l).
    25. Transferrin saturation (TSAT): <20%.
    CRITERIOS RELACIONADOS CON LA ERC 1.Modalidad de diálisis: Cambio programado de HD a diálisis peritoneal dentro del período del estudio. 2.Trasplante renal: Programado para un trasplante renal de un donante vivo emparentado. 3.Dosis alta de FEE: Dosis de epoetina de >=360 UI/kg/semana IV o >=250 UI/kg/semana por vía subcutánea (SC) o dosis de darbepoetina >=1,8 µg/kg/semana por vía IV o SC o dosis de metoxi PEG-epoetina beta de >=2,2 µg/kg/semana en las 8 semanas previas hasta el día 1 (aleatorización) 4.Mircera: Administración de Mircera en las 4 semanas previas hasta el día 1 (aleatorización). CRITERIOS RELACIONADOS CON ENFERMEDAD CARDIOVASCULAR 5.Infarto de miocardio o síndrome coronario agudo: En las 8 semanas previas a la selección hasta el día 1 (aleatorización).6.Ictus o accidente isquémico transitorio: En las 8 semanas previas a la selección hasta el día 1 (aleatorización).7.Insuficiencia cardíaca: Insuficiencia cardíaca de clase IV, según la definición del sistema de clasificación funcional de la NYHA diagnosticada antes de la selección y hasta el día 1 (aleatorización). 8.QTcB: QTcB >500 ms o QTcB >530 ms en sujetos con bloqueo de rama. No hay un criterio de exclusión de QTc para los sujetos con un ritmo predominantemente de marcapasos.CRITERIOS RELACIONADOS CON OTRAS ENFERMEDADES 9.Enfermedades inflamatorias: Enfermedad inflamatoria crónica activa que podría afectar a la eritropoyesis diagnosticada antes de la selección y hasta el día 1 (aleatorización). 10.Enfermedades hematológicas: Cualquier enfermedad hematológica, incluidas las que afectan a plaquetas, leucocitos o eritrocitos , trastornos de la coagulación o cualquier otra causa de anemia de enfermedad crónica distinta de enfermedad renal diagnosticada antes de la selección y hasta el día 1 (aleatorización).
    11.Hepatopatía: Hepatopatía actual, anomalías hepáticas o biliares conocidas (a excepción de síndrome de Gilbert o colelitiasis asintomática) o signos de anomalías en las pruebas de función hepática realizadas en la selección ALT o AST más de 2 veces por encima del límite superior de la normalidad o bilirrubina total >1,5 veces el LSN; u otras anomalías hepáticas que, en opinión del investigador, descarten la participación del sujeto en el estudio. NOTA: Los sujetos con hepatitis B o hepatitis C podrán participar en el estudio siempre que no cumplan los siguientes criterios de exclusión.12.Cirugía mayor: Cirugía mayor (excluida cirugía de acceso vascular) en las 8 semanas previas al período de selección, durante la fase de selección o programada durante el estudio.13.Transfusión: Transfusión de sangre en las 8 semanas previas a la selección, durante la fase de selección o necesidad prevista de transfusión de sangre durante el estudio.14.Hemorragia digestiva: Signos de enfermedad por úlcera péptica, duodenal o esofágica con hemorragia activa O hemorragia digestiva clínicamente significativa en las 8 semanas previas a la selección y hasta el día 1 (aleatorización). 15.Infección aguda: Signos clínicos de infección aguda o antecedentes de infección que precisa tratamiento con antibióticos por vía intravenosa (IV) en las 4 semanas previas a la selección hasta el día 1 (aleatorización). 16.Neoplasia maligna: Antecedentes de neoplasia maligna en los dos años previos a la aleatorización o tratamiento actual para el cáncer, o presencia de un quiste renal complejo conocido con un tamaño superior a los 4 cm (esto es, categoría de Bosniak II F, III o IV). MEDICAMENTOS CONCOMITANTES. 17.Reacciones alérgicas intensas: Antecedentes de reacciones alérgicas o anafilácticas intensas o hipersensibilidad a los excipientes del producto en investigación. 18.Medicamentos y suplementos: Uso de medicamentos de venta con o sin receta o suplementos dietéticos que estén prohibidos desde la selección hasta la visita de seguimiento. 19.Exposición previa al producto en investigación: El sujeto ha participado en un ensayo clínico y ha recibido un fármaco en investigación experimental en los 30 días previos a la selección y hasta el día 1 (aleatorización). CRITERIOS RELACIONADOS CON EL ESTADO DE SALUD GENERAL 20. Cualquier otro trastorno, anomalía clínica o analítica, o resultado de una exploración que el investigador considere que pueda poner al paciente en riesgo inaceptable, el cual pueda afectar al cumplimiento del estudio o que impida comprender los objetivos, los procedimientos de investigación o las posibles consecuencias del estudio. 21.Mujeres SÓLO: No cumple los criterios de elegibilidad para las mujeres (sección 12.6 apéndice 6 of stuy protocol). EVALUACIONES DIAGNÓSTICAS Y OTROS CRITERIOS 22.Vitamina B12: En o por debajo del límite inferior del intervalo de referencia (se puede repetir la selección en un plazo mínimo de 8 semanas). 23. Folato: <2,0 ng/ml (4,5 nmol/l) (se puede repetir la selección en un plazo mínimo de 4 semanas). 24.Ferritina: <100 ng/ml (<100 µg/l). 25. Saturación de la transferrina (TSAT): <20%.
    E.5 End points
    E.5.1Primary end point(s)
    Hgb change from baseline
    Variación de Hgb desde el momento basal hasta el día 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    Dia 29
    E.5.2Secondary end point(s)
    -Maximum observed change from baseline in EPO
    -Maximum observed % change from baseline in VEGF
    - Change from baseline in hepcidin at Day 29
    - Change from baseline in hematocrit, red blood cell (RBC) count, reticulocyte count and reticulocyte Hgb (CHr) at Day 29
    -Descriptive PK summaries of GSK1278863 and major metabolites
    - Incidence and severity of AEs and SAEs
    - Reasons for discontinuation of investigational product
    -Discontinuation for safety-related reasons, e.g., pre-specified stopping criteria or AE
    -Absolute values and changes from baseline over time in laboratory parameters, ECGs and vital signs
    -Variación máxima observada de la EPO respecto al momento basal
    -Variación porcentual máxima observada del VEFG respecto al momento basal
    -Variación de la hepcidina desde el momento basal hasta el día 29
    -Variación de hematocrito, recuento de eritrocitos, recuento de reticulocitos y Hgb reticulocitaria (CHr) desde el momento basal hasta el día 29
    -Resúmenes descriptivos de la FC de GSK1278863 y los metabolitos principales
    -Incidencia e intensidad de AA y AAG
    -Posibles motivos para la suspensión del producto en investigación
    -Suspensión por motivos relacionados con la seguridad; p. ej., criterios de interrupción o AA predefinidos
    -Valores absolutos y variación de los parámetros de laboratorio, ECG y constantes vitales respecto al valor basal a lo largo del tiempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    29 Days
    29 dias
    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 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 trial5
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Russian Federation
    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
    Last Subject Last Visit (LSLV)
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    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)
    Subjects will not receive any additional treatment from GSK after completion of the study.
    The investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject?s medical condition, whether or not GSK is providing specific post-study 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 Decision2016-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-21
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