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    Summary
    EudraCT Number:2014-004942-91
    Sponsor's Protocol Code Number:1423M0634
    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:2015-04-27
    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 number2014-004942-91
    A.3Full title of the trial
    A Phase 3 Randomised, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of S-888711 (Lusutrombopag) for the Treatment of Thrombocytopenia in Patients with Chronic Liver Disease Undergoing Elective Invasive Procedures (L-PLUS 2)
    Estudio de fase 3, aleatorizado, a doble ciego, controlado con placebo, para evaluar la seguridad y eficacia de S 888711 (Lusutrombopag) para el tratamiento de trombocitopenia Estudio de fase 3, aleatorizado, a doble ciego, controlado con placebo, para evaluar la seguridad y eficacia de S 888711 (Lusutrombopag) para el tratamiento de trombocitopenia en pacientes con hepatopatía crónica que se sometan a procedimientos invasivos programados (L-PLUS 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study of Lusutrombopag for the Treatment of Thrombocytopenia in Patients with Chronic Liver Disease Undergoing Elective Invasive Procedures
    Estudio de seguridad y eficacion de Lusutrombopag para el tratamiento de trombocitopenia en pacientes con hepatopatía crónica que se sometan a procedimientos invasivos programados.
    A.3.2Name or abbreviated title of the trial where available
    L-PLUS 2
    L-PLUS 2
    A.4.1Sponsor's protocol code number1423M0634
    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 SponsorShionogi 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 supportShionogi & Co., Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShionogi & Co., Ltd
    B.5.2Functional name of contact pointCorporate Communications Department
    B.5.3 Address:
    B.5.3.1Street Address1-8, Doshomachi 3-chome
    B.5.3.2Town/ cityChuo-ku, Osaka
    B.5.3.3Post code541-0045
    B.5.3.4CountryJapan
    B.5.4Telephone number+816 6209 7885
    B.5.6E-mailshionogiclinicaltrial888711@shionogi.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 nameLusutrombopag
    D.3.2Product code S-888711
    D.3.4Pharmaceutical form Film-coated 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 INNLusutrombopag
    D.3.9.1CAS number 1110766-97-6
    D.3.9.2Current sponsor codeS-888711
    D.3.9.3Other descriptive nameLUSUTROMBOPAG
    D.3.9.4EV Substance CodeSUB170962
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.0
    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 placeboFilm-coated tablet
    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
    Thrombocytopenia in patients with Chronic Liver Disease (CLD)
    Trombocitopenia en pacientes con hepatopatía crónica.
    E.1.1.1Medical condition in easily understood language
    Thrombocytopenia in patients with Chronic Liver Disease (CLD)
    Trombocitopenia en pacientes con hepatopatía 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 18.0
    E.1.2Level PT
    E.1.2Classification code 10043554
    E.1.2Term Thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of S-888711 with placebo for the treatment of thrombocytopenia in patients with CLD who are undergoing elective invasive procedures
    ? Comparar la eficacia de S 888711 con la de un placebo para el tratamiento de la trombocitopenia en pacientes con HC que se someten a procedimientos invasivos programados.
    E.2.2Secondary objectives of the trial
    ?To assess the safety and tolerability of S-888711 treatment compared with placebo
    ?To assess the platelet response following treatment with S-888711 compared with placebo
    ?To assess the pharmacodynamics and pharmacokinetics of S-888711
    ? Evaluar la seguridad y tolerabilidad del tratamiento con S-888711 en comparación con un placebo.
    ? Evaluar la respuesta plaquetaria después del tratamiento con S 888711 en comparación con un placebo.
    ? Evaluar la farmacodinámica (PD) y farmacocinética (PK) de S 888711.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand the study and comply with all the study procedures.
    2. Willing to provide written informed consent prior to Screening.
    3. Male or female.
    4. 18 years of age or older at the time of signing informed consent.
    5. CLD limited to Child Pugh Class A and Class B disease (see Appendix 3).
    6. Platelet count < 50 × 109/L at baseline on Day 1 prior to randomisation.
    7. Undergoing an elective invasive procedure that:
    ? is likely to require administration of platelets
    ? is expected to be performed between Days 9 and 14
    ? does not include laparotomy, thoracotomy, craniotomy, open heart surgery, organ resection, or
    ? does not include partial organ resection (however, biopsy and other types of tissue removal will be allowed if risk of bleeding and invasiveness is considered comparable or lower than those procedures in the list of example procedures; see Appendix 4).
    8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1 (see Appendix 5).
    9. In the opinion of the investigator, able to meet the requirements of the study.
    10. Male patients who are sterile or who agree to use an appropriate method of contraception (including use of a condom with spermicide) from Screening to completion of the Post treatment period.
    11. Female patients who are not postmenopausal or surgically sterile need to agree to use a highly effective contraception (including contraceptive implant, injectable contraceptive, combination hormonal contraceptive [including vaginal rings], intrauterine contraceptive device or vasectomised partner) from Screening to completion of the Post treatment period. Barrier method with or without spermicide, double barrier contraception and oral contraceptive pill are insufficient methods on their own.
    1. Poder comprender el estudio y cumplir con todos los procedimientos del estudio.
    2. Estar dispuesto a prestar consentimiento informado por escrito antes de la Selección.
    3. Hombre o mujer.
    4. Tener 18 años de edad o más al momento de la firma del consentimiento informado.
    5. HC limitada a enfermedad de clase A y clase B de Child Pugh (consulte el Apéndice 3).
    6. Recuento plaquetario <50 × 109/l en el inicio el Día 1 antes de la aleatorización.
    7. Someterse a un procedimiento invasivo programado que:
    ? probablemente requiera la administración de plaquetas;
    ? está previsto realizarlo entre los Días 9 y 14;
    ? no incluya laparotomía, toracotomía, craneotomía, cirugía a corazón abierto, resección de órgano;
    ? no incluya resección parcial de órgano (sin embargo, se permitirá realizar una biopsia y otros tipos de extirpaciones de tejido si el riesgo de sangrado e invasión se considera comparable o inferior a los procedimientos de la lista de ejemplos de procedimientos; consulte el Apéndice 4).
    8. Nivel de desempeño (performance status, PS) de 0 o 1 según el Grupo Oncológico Cooperativo del Este (ECOG) (consulte el Apéndice 5).
    9. Según la opinión del investigador, ser capaz de cumplir los requisitos del estudio.
    10. Pacientes hombres que aceptan usar un método anticonceptivo adecuado (incluido el uso de un condón con espermicida) desde la Selección hasta la finalización del Período posterior al tratamiento.
    11. Las pacientes mujeres que no son posmenopáusicas ni quirúrgicamente estériles deben aceptar usar un método anticonceptivo altamente eficaz (que incluye implante anticonceptivo, anticonceptivo inyectable, anticonceptivo hormonal de combinación [incluidos anillos vaginales], dispositivo anticonceptivo intrauterino o tener una pareja que se haya realizado vasectomía) desde la Selección hasta la finalización del Período posterior al tratamiento. El método de barrera con o sin espermicida, la anticoncepción de doble barrera y las píldoras anticonceptivas orales son de por sí métodos insuficientes.
    E.4Principal exclusion criteria
    1. Any of the following diseases:
    ? haematopoietic tumour
    ? aplastic anaemia
    ? myelodysplastic syndrome
    ? myelofibrosis
    ? congenital thrombocytopenia
    ? drug induced thrombocytopenia
    ? generalised infection requiring treatment except for viral liver disease
    ? immune thrombocytopenia.
    2. Any solid malignant tumour if:
    ? the patient requires systemic chemotherapy or radiotherapy for that malignant tumour during the study
    ? the malignant tumour is associated with nodal metastasis, distant metastasis, or invasion of the surrounding organs
    ? The exceptions are:
    - a malignant tumour that is the treatment target of the primary invasive procedure
    - non melanoma skin cancer, intramucosal cancer, or carcinoma in situ not requiring any treatment during the study.
    3. History of splenectomy.
    4. History of liver transplantation.
    5. Any of the following at Screening:
    ? hepatic encephalopathy uncontrolled by drugs
    ? ascites uncontrolled by drugs.
    6. Portal vein tumour embolism.
    7. Known to be positive for the human immunodeficiency virus.
    8. Past or present thrombosis or prothrombotic condition (eg, cerebral infarction, myocardial infarction, angina pectoris, coronary artery stent placement, angioplasty, coronary artery bypass grafting, congestive heart failure [New York Heart Association {NYHA} Grade III/IV], arrhythmia known to increase the risk of thromboembolic events [eg, atrial fibrillation], pulmonary thromboembolism, deep vein thrombosis, or disseminated intravascular coagulation syndrome).
    9. History or evidence of any of the following diseases:
    ? congenital thrombotic disease (eg, antithrombin deficiency, protein C deficiency, protein S deficiency, or coagulation factor [Factor V Leiden] mutation)
    ? acquired thrombotic disease (eg, antiphospholipid antibody syndrome, paroxysmal nocturnal haemoglobinuria, hyperhomocysteinaemia, or increased factor VIII)
    ? Budd Chiari syndrome.
    10. Portal vein thrombosis based on ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) within 28 days prior to randomisation or a history of portal vein thrombosis.
    11. Absence of hepatopetal blood flow in the main trunk of the portal vein as demonstrated by Doppler ultrasonography within 28 days prior to randomisation.
    12. Untreated gastro-oesophageal varices that are bleeding or require treatment based on upper gastrointestinal endoscopy within 180 days prior to randomisation (except for patients in whom the primary invasive procedure is for the treatment of gastro oesophageal varices).
    13. History or evidence of disease associated with a risk of bleeding (eg, coagulation factor deficiency or von Willebrand factor deficiency).
    14. Bleeding score at randomisation ? Grade 2 according to the World Health Organization (WHO) Bleeding Scale (see Appendix 7).
    15. Any of the following drugs or therapies within 90 days prior to randomisation:
    ? anticancer drugs except for transcatheter arterial chemoembolisation (TACE) and lipiodolisation
    ? interferon preparations
    ? radiation therapy
    ? exsanguination
    ? other TPO receptor agonist
    ? any investigational agent.
    16. Any of the following invasive procedures within 90 days prior to randomisation:
    ? laparotomy, thoracotomy, craniotomy, or open heart surgery
    ? procedures involving any organ resection or any partial organ resection (tissue resection associated with an endoscopic examination is permitted)
    ? partial splenic embolisation.
    17. Any invasive procedure (except for the treatment of gastro oesophageal varices) within 14 days prior to randomisation.
    18. Blood transfusion (except for red blood cell products and albumin preparations) within 14 days prior to randomisation.
    19. Patients who have received S-888711 before.
    20. Pregnant or lactating female.
    21. Patients with known or suspected ongoing, active alcohol or substance abuse. Patients with a recent history who the investigator feels are able to comply with the study procedures and medications will be allowed to participate.
    22. Considered ineligible by the investigator for any other reason.
    1. Alguna de las siguientes enfermedades:
    ? tumor hematopoyético;
    ? anemia aplásica;
    ? síndrome mielodisplásico;
    ? mielofibrosis;
    ? trombocitopenia congénita;
    ? trombocitopenia inducida por fármaco;
    ? infección generalizada que requiere un tratamiento, salvo hepatopatía vírica;
    ? trombocitopenia inmunitaria.
    2.Cualquier tumor maligno sólido si:
    ? El paciente requiere quimioterapia o radioterapia sistémica para dicho tumor maligno durante el estudio.
    ? El tumor maligno está asociado con una metástasis ganglionar, metástasis distante o invasión de los órganos circundantes.
    ? Las excepciones son:
    - un tumor maligno que es el objetivo de tratamiento del procedimiento invasivo primario;
    - cáncer de piel no melanoma, cáncer intramucoso o carcinoma in situ que no requiere ningún tratamiento durante el estudio.
    3.Antecedentes de esplenectomía.
    4.Antecedentes de trasplante hepático.
    5.Cualquiera de los siguientes en la Selección:
    ? encefalopatía hepática no controlada con fármacos;
    ? ascitis no controlada con fármacos.
    6. Embolia tumoral de la vena porta.
    7. Resultado positivo confirmado de virus de inmunodeficiencia humana.
    8. Trombosis o afección protrombótica pasada o actual (p. ej., infarto cerebral, infarto de miocardio, angina de pecho, colocación de endoprótesis en arteria coronaria, angioplastía, cirugía de revascularización de arteria coronaria, insuficiencia cardíaca congestiva [grado III/IV de la Asociación Cardíaca de Nueva York {NYHA}], arritmia que se sabe aumenta el riesgo de eventos tromboembólicos [p. ej., fibrilación auricular], tromboembolia pulmonar, trombosis venosa profunda o síndrome de coagulación intravascular diseminado).
    9. Antecedentes o evidencia de cualquiera de las siguientes enfermedades:
    ? enfermedad trombótica congénita (p. ej., deficiencia antitrombina, deficiencia de proteína C, deficiencia de proteína S o mutación del factor de coagulación [Factor V de Leiden]);
    ? enfermedad trombótica adquirida (p. ej., síndrome de anticuerpos antifosfolípidos, hemoglobinuria nocturna paroxística, hiperhomocisteinemia o aumento del factor VIII);
    ? Síndrome de Budd Chiari.
    10. Trombosis de la vena porta diagnosticada mediante ecografía, tomografía computada (TC) o resonancia magnética (RM) dentro de los 28 días antes de la aleatorización o antecedentes de trombosis de la vena porta.
    11. Ausencia de flujo sanguíneo hepatopetal en el tronco principal de la vena porta, demostrada mediante ecografía Doppler dentro de los 28 días anteriores a la aleatorización.
    12. Várices gastroesofágicas no tratadas que presentan sangrado o requieren tratamiento, determinado mediante endoscopia del tracto gastrointestinal superior, dentro de los 180 días antes de la aleatorización (salvo los pacientes en los que el procedimiento invasivo primario es para tratar várices gastroesofágicas).
    13. Antecedentes o evidencia de enfermedad asociada con riesgo de sangrado (p. ej., deficiencia del factor de coagulación o deficiencia del factor de von Willebrand).
    14. Puntaje de sangrado en la aleatorización ? grado 2 según la escala de sangrado de la Organización Mundial de la Salud (OMS) (consulte el Apéndice 7).
    15. Cualquiera de los siguientes fármacos o tratamientos dentro de los 90 días antes de la aleatorización:
    ? fármacos antineoplásicos, excepto la quimioembolización arterial transcatéter (QATC) y lipiodolización;
    ? preparaciones de interferón;
    ? radioterapia;
    ? desangrado;
    ? otro agonista del receptor de TPO;
    ? cualquier agente en investigación.
    16. Cualquiera de los siguientes procedimientos invasivos dentro de los 90 días antes de la aleatorización:
    ? laparotomía, toracotomía, craneotomía, cirugía a corazón abierto;
    ? procedimientos que implican cualquier resección de órgano o resección parcial de órgano (se permite una resección de tejido asociada con un examen endoscópico);
    ? embolización esplénica parcial.
    17. Cualquier procedimiento invasivo (salvo el tratamiento de várices gastroesofágicas) dentro de los 14 días antes de la aleatorización.
    18. Transfusión de sangre (salvo productos derivados de glóbulos rojos y preparaciones de albúmina) dentro de los 14 días antes de la aleatorización.
    19. Pacientes que ya han recibido S-888711.
    20. Mujeres embarazadas o en período de lactancia.
    21. Pacientes con drogadicción o alcoholismo activo, confirmado o posiblemente en curso. Se permitirá participar a los pacientes con antecedentes recientes que el investigador considere que pueden cumplir con los procedimientos y medicamentos del estudio.
    22. Personas que el investigador considere no elegibles por cualquier otro motivo.
    E.5 End points
    E.5.1Primary end point(s)
    ?Proportion of patients who require no platelet transfusion prior to the primary invasive procedure and no rescue therapy for bleeding from randomisation through 7 days after the primary elective procedure.
    ? Proporción de pacientes que no necesitan ninguna transfusión de plaquetas antes del procedimiento invasivo primario ni ninguna terapia de rescate para sangrado desde la aleatorización hasta 7 días después del procedimiento programado primario
    E.5.1.1Timepoint(s) of evaluation of this end point
    On or after Day 8, but no more than 2 days prior to the elective invasive procedure.
    Se realizará un recuento de plaquetas después del Día 8 inclusive, pero no más de 2 días antes del procedimiento invasivo programado
    E.5.2Secondary end point(s)
    ?Proportion of patients who require no platelet transfusion during the study
    ?Proportion of responders: patients who achieve a platelet count of ? 50 × 109/L with an increase of ? 20 × 109/L from baseline at any time during the study
    ?Duration of the platelet count defined as the number of days during which the platelet count was maintained as ? 50 × 109/L
    ?Proportion of patients who require rescue therapy for bleeding at any time during the study
    ?Frequency of platelet transfusions
    ?The change from baseline in platelet count over time (time course of platelet count)
    ?Safety and tolerability
    ?Assessment of plasma concentrations of S-888711
    ? Proporción de pacientes que no requieren ninguna transfusión de plaquetas durante el estudio.
    ? Proporción de sujetos que responden: pacientes que alcanzan un recuento plaquetario ?50 × 109/l con un aumento ?20 × 109/l desde el inicio en cualquier momento durante el estudio.
    ? Duración del recuento plaquetario definido como la cantidad de días durante los cuales el recuento plaquetario se mantuvo ?50 × 109/l.
    ? Proporción de pacientes que requieren una terapia de rescate para sangrado en cualquier momento durante el estudio.
    ? Frecuencia de transfusiones de plaquetas.
    ? El cambio desde el inicio en el recuento plaquetario con el tiempo (evolución temporal del recuento plaquetario).
    ? Seguridad y tolerabilidad.
    ? Evaluación de concentraciones plasmáticas de S 888711.
    E.5.2.1Timepoint(s) of evaluation of this end point
    63 days
    63 días
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Argentina
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    LVLS
    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 months8
    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 months8
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 123
    F.4.2.2In the whole clinical trial 200
    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)
    After participation in the trial patients will be treated with the current standard therapy and no additional trial medication will be made available.
    Los pacientes del estudio volveran a su cuidado estandar despues de su participacion en el estudio y no tendran a su disposición la medicacion del 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 Decision2015-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-19
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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