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    Summary
    EudraCT Number:2008-003800-73
    Sponsor's Protocol Code Number:12011.201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-05-26
    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 number2008-003800-73
    A.3Full title of the trial
    A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients

    Ensayo clínico de fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos y búsqueda de dosis para investigar la eficacia y la seguridad de 10 y 20 mg/día de Ciclosporina A Liposómica aerosolizada (L-CsA) frente a placebo aerosolizado en la prevención del síndrome de bronquiolitis obliterante (SBO) en pacientes con trasplante pulmonar
    A.4.1Sponsor's protocol code number12011.201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPari Pharma GmbH
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/210
    D.3 Description of the IMP
    D.3.1Product nameCiclosporina A Liposomica Aerolised Liposomal Ciclosporin A
    D.3.2Product code L-CsA
    D.3.4Pharmaceutical form Powder for nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    Interstitial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiclosporina/ Ciclosporin
    D.3.9.1CAS number 59865-13-3
    D.3.9.2Current sponsor code081400
    D.3.9.3Other descriptive nameCiclosporine, Ciclosporina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/210
    D.3 Description of the IMP
    D.3.1Product nameCiclosporina A Liposomica Aerolised Liposomal Ciclosporin A
    D.3.2Product code L-CsA
    D.3.4Pharmaceutical form Powder for nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiclosporina / Ciclosporin
    D.3.9.1CAS number 59865-13-3
    D.3.9.2Current sponsor code081400
    D.3.9.3Other descriptive nameCiclosporine, Ciclosporina
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Yes
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    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 nameSolucion de cloruro de sodio Sodium Chloride Solution
    D.3.2Product code Solvente Cloruro de Sodio Sodium Chloride Solvent
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCloruro de sodio
    D.3.9.3Other descriptive nameCloruro de sodio
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 nameSolucion de Cloruro de Sodio
    D.3.2Product code Solvente de Cloruro de Sodio
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCloruro de Sodio
    D.3.9.3Other descriptive nameCloruro de Sodio
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder for nebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for nebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of bronchiolitis obliterans syndrome in lung transplant

    Prevención del sindrome de bronquiolitis obliterante en transplante pulmonar
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049202
    E.1.2Term Bronchiolitis obliterans
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal es investigar la eficacia y la seguridad de la administración de L-CsA con el cociente de riesgo a beneficio más favorable para la prevención del síndrome de bronquiolitis obliterante en pacientes con trasplante del pulmón.


    The primary objective is to investigate efficacy and safety of L-CsA dosage with the most favourable risk-benefit ratio for the prevention of BOS in LT patients
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son comparar con el placebo los datos de eficacia y seguridad de las dosis de L-CsA y evaluar los datos farmacocinéticos (PC) del producto en fase de investigación clínica en todas las muestras de sangre y lavado broncoalveolar (LBA).

    To compare further efficacy and safety data from the IMP versus placebo and to evaluate IMP PK data in whole blood and BAL samples
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimiento informado por escrito del paciente obtenido antes de realizar cualquier procedimiento de selección
    2. Haber recibido un trasplante pulmonar simple, un trasplante pulmonar bilateral o un trasplante de corazón y pulmón entre seis semanas y 26 semanas antes de la primera administración del producto en fase de investigación clínica
    3. Varón o mujer, ? 18 años de edad
    4. Capacidad de autoadministración de los medicamentos
    5. Capacidad de entender el propósito y el riesgo del ensayo clínico
    6. Haber recibido una semana antes de la primera administración del PEI, los siguientes inmunosupresores y dosis para tratamiento de mantenimiento:
    a) Tacrolimus, aproximadamente 0,1 a 0,2 mg/kg/día
    ajustados a una concentración sérica deseada (C0, mínima) de 8 a 15 µg/l y
    b) Micofenolato mofetilo (MMF) 1 a 3 g/día y
    c) Prednisona por vía oral; en dosis descendentes en los tres primeros meses después del trasplante
    7. Las pacientes fértiles deben tener una prueba de embarazo en orina negativa antes de la primera administración del PEI. Las mujeres y los varones deben aceptar el uso de un método médicamente aceptable de anticoncepción durante todo el periodo de tratamiento con el PEI y durante tres meses después de interrumpir la administración del PEI. En el anexo II se indican los métodos anticonceptivos aceptables.
    8. Esperanza de vida estimada > 6 meses
    E.4Principal exclusion criteria
    1. Cualquier episodio previo de bronquiolitis obliterante (BO) o de síndrome de bronquiolitis obliterante (SBO) de grado 1 o superior
    2. Cualquier infección bacteriana, vírica o fúngica invasora activa en la semana previa a la primera administración del PEI
    3. Tratamiento inmunodepresor de mantenimiento sistémico recibido distinto del indicado en los criterios de inclusión en la semana previa a la primera administración del PEI
    4. Haber recibido ciclosporina A sistémica o tópica en la semana previa a la primera administración del PEI o durante el ensayo clínico
    5. Haber recibido Rosuvastatina sistémica o tópica en la semana previa a la primera administración del PEI o durante el ensayo clínico
    6. Ventilación mecánica actual
    7. Haber recibido un retrasplante de pulmón
    8. Mujer embarazada o lactante
    9. Tener hipersensibilidad conocida a la ciclosporina A
    10. Tener un valor sérico de creatinina superior a 265 µmol/l (3 mg/dl) o en diálisis crónica (hemodiálisis)
    11. Improbabilidad de que cumpla las visitas, los procedimientos de inhalación o las medidas espirométricas programadas en el protocolo
    12. Haber recibido un fármaco experimental como parte de un ensayo clínico en las cuatro semanas previas a la primera
    administración del PEI
    13. Cualquier dolencia médica coexistente que, a juicio del investigador, aumente sustancialmente el riesgo asociado con la participación del paciente en el ensayo clínico
    14. Trastornos psiquiátricos o estado mental alterado que impidan la comprensión del proceso de consentimiento informado o la realización de los procedimientos necesarios
    15. Inclusión previa del paciente en el ensayo clínico presente
    E.5 End points
    E.5.1Primary end point(s)
    ? Supervivencia acumulada sin SBO durante el periodo del ensayo clínico
    ? Volumen espiratorio forzado medio en un segundo (VEF1) al comienzo y 12, 18 y 24 meses después de la primera administración del PEI
    ? Pendiente del VEF1 medio desde el comienzo hasta los 12, 18 y 24 meses siguientes a la primera administración del PEI
    ? Flujo espiratorio intermedio forzado (FEF25-75) medio, capacidad vital (CV) y capacidad pulmonar total (CPT) al comienzo y 12, 18 y 24 meses después de la primera administración del PEI
    ? Capacidad de difusión media mediante respiración única (DLCO) y gases sanguíneos capilares a los 6, 12, 18 y 24 meses después de la primera administración del PEI
    ? Incidencia media acumulada de SBO a los 12,18 y 24 meses después de la primera administración del PEI
    ? Incidencia media acumulada de infección bacteriana, vírica o fúngica invasora 12,18 y 24 meses después de la primera administración del PEI
    ? Incidencia media acumulada de pérdida de injerto pulmonar 12, 18 y 24 meses después de la primera administración del PEI
    ? Distancia media recorrida en la prueba de marcha de seis minutos a los 6, 12 y 24 meses después de la primera administración del PEI
    ? Dosis acumulada media de inmunodepresores de mantenimiento 12, 18 y 24 meses después de la primera administración del PEI
    ? Número medio acumulado de procedimientos no contemplados en el protocolo que precise estancias hospitalarias 12, 18 y 24 meses después de la primera administración del PEI
    ? Concentración media de marcadores inflamatorios y de L-CsA del lavado broncoalveolar (LBA) de como mínimo dos visitas durante el periodo del ensayo clínico
    ? Supervivencia global acumulada durante el periodo del ensayo clínico

    Criterios de valoración de seguridad:
    ? Incidencia de AA, entre ellos constantes vitales y variables analíticas clínicamente significativas
    ? Variables analíticas clínicas
    ? Constantes vitales
    ? Exploración física
    ? Concentraciones farmacocinéticas mínimas de L-CsA y tacrolimus

    Criterios de valoración descriptivos:
    ? Incidencia media acumulada de rechazo agudo de grado A2 o superior 12, 18 y 24 meses después de la primera administración del PEI
    ? Concentraciones de sacarosa en los lavados broncoalveolares
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Ultimo paciente, ultima visita

    Last patient last visit
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 134
    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 Decision2010-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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