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    Summary
    EudraCT Number:2008-000660-17
    Sponsor's Protocol Code Number:TPL108392
    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:2009-06-25
    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 number2008-000660-17
    A.3Full title of the trial
    TPL108392: “Estudio abierto, multicéntrico y con cambio de grupo para evaluar la seguridad y la eficacia de eltrombopag en sujetos trombocitopénicos con infección por el virus de la hepatitis C (VHC) que por lo demás son elegibles para iniciar tratamiento antiviral (peginterferón alfa-2a o peginterferón alfa-2b más ribavirina)”. Fase III.
    A.3.2Name or abbreviated title of the trial where available
    ENABLE ALL
    A.4.1Sponsor's protocol code numberTPL108392
    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 SponsorGlaxoSmithKline
    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 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 numberEMEA/OD/031/07
    D.3 Description of the IMP
    D.3.1Product nameEltrombopag
    D.3.2Product code SB-497115
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEltrombopag
    D.3.9.1CAS number CASRN496775
    D.3.9.2Current sponsor codeSB-497115
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeNew chemical entity
    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 numberEMEA/OD/031/07
    D.3 Description of the IMP
    D.3.1Product nameEltrombopag
    D.3.2Product code SB-497115
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEltrombopag
    D.3.9.1CAS number CASRN496775
    D.3.9.2Current sponsor codeSB-497115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 Yes
    D.3.11.13.1Other medicinal product typeNew chemical entity
    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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/031/07
    D.3 Description of the IMP
    D.3.1Product nameEltrombopag
    D.3.2Product code SB-497115
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEltrombopag
    D.3.9.1CAS number CASRN496775
    D.3.9.2Current sponsor codeSB-497115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    D.3.11.13.1Other medicinal product typeNew chemical entity
    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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/031/07
    D.3 Description of the IMP
    D.3.1Product nameEltrombopag
    D.3.2Product code SB-497115
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEltrombopag
    D.3.9.1CAS number CASRN496775
    D.3.9.2Current sponsor codeSB-497115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeNew chemical entity
    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
    Sujetos infectados con Hepatitis C con trombocitopenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la seguridad y la tolerabilidad de eltrombopag en régimen abierto cuando se administra una vez al día
    E.2.2Secondary objectives of the trial
    • Evaluar los recuentos plaquetarios antes y durante el tratamiento antiviral.
    • Evaluar el mantenimiento del tratamiento antiviral.
    • Evaluar la consecución de los puntos clave del tratamiento antiviral.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Sujetos varones y mujeres,mayor e igual 18 años de edad.
    2.Evidencia de infección crónica por el VHC (ARN cuantificable del VHC, límite inferior de detección de 50 UI/ml).
    3.Los sujetos deben haber participado previamente en los estudios TPL103922 (ENABLE 1) o TPL108390 (ENABLE 2) y deben haber iniciado con éxito el tratamiento antiviral en esos estudios.
    4.Los sujetos deben haber suspendido de forma permanente por motivo de trombocitopenia todos los productos en investigación de los estudios ENABLE 1 ó 2 en las 12 semanas siguientes a su aleatorización en esos estudios. Los sujetos que continuaron el tratamiento antiviral pasadas 6 semanas tienen que haber tenido cierto grado de trombocitopenia durante este tiempo, definida como una reducción de al menos el 50 % en la dosis de IFN pegilado (por motivos de trombocitopenia) durante un período mínimo de 4 semanas.
    5.Todos los sujetos deben haber completado las evaluaciones de seguimiento de RVS y las evaluaciones oculares finales, a los 6 meses (24 semanas) en los estudios ENABLE 1 o ENABLE 2.
    6.Sujetos que, en opinión del investigador, son candidatos apropiados para el retratamiento con terapia combinada antiviral de peginterferón alfa y ribavirina.
    7.Recuento plaquetario de < 75.000 mcl.
    8.Todos los hombres y mujeres fértiles deben utilizar dos métodos de contracepción eficaces durante el tratamiento y durante las 24 semanas siguientes a la finalización del tratamiento.
    9.Una mujer es elegible para participar en este estudio si:
    •No tiene capacidad para concebir (es decir, es fisiológicamente imposible que se quede embarazada), incluidas las mujeres que:
    -se han sometido a una histerectomía
    -se han sometido a una ooforectomía (ovariectomía) bilateral
    -se han sometido a una ligadura de trompas bilateral
    -se encuentran en la etapa posmenopáusica (demuestra una cesación total de la menstruación durante más de un año)
    •Tiene capacidad para concebir, tiene una prueba negativa de embarazo en orina o en suero en el momento de la selección y en las 24 horas previas a la primera dosis de eltrombopag, y se abstiene completamente de mantener relaciones sexuales durante las dos semanas previas a la exposición al fármaco del estudio, durante la totalidad del ensayo clínico y en las 24 semanas siguientes a la finalización del estudio o a la interrupción prematura del estudio.
    •Tiene capacidad para concebir, tiene una prueba de embarazo en orina o sangre negativa en la selección y en las 24 horas previas a la primera dosis de eltrombopag y utiliza dos de los siguientes métodos anticonceptivos aceptables:
    - Cualquier dispositivo intrauterino (DIU) con una tasa documentada de fracaso menor del 1 % anual.
    - Método de doble barrera (preservativo con espermicida o diafragma con espermicida).
    - Pareja masculina estéril antes de que la mujer entre en el estudio y es el único compañero sexual de esa mujer.
    - Anticonceptivo oral (combinado o sólo progestágeno).
    - Cualquier método anticonceptivo con una tasa documentada de fracaso menor del 1 % anual.
    10.El sujeto puede comprender y cumplir los requisitos del protocolo y las instrucciones y es probable que complete el estudio según lo previsto.
    11.El sujeto es capaz de proporcionar el consentimiento informado por escrito.
    12.En Francia sólo se podrá incluir en este estudio a los sujetos afiliados o beneficiarios de alguna categoría de la seguridad social.
    E.4Principal exclusion criteria
    1.Hepatopatía descompensada.
    2.Hipersensibilidad, intolerancia o alergia conocidas al interferón, ribavirina, eltrombopag o cualquiera de sus ingredientes.
    3.Antecedentes documentados de hemorragia clínicamente significativa por varices esofágicas o gástricas.
    4.Cualquier antecedente de trombosis arterial o venosa Y mayor e igual a 2 de los siguientes factores de riesgo: trastornos trombofílicos hereditarios (p. ej., factor V Leiden, déficit de ATIII, etc.) terapia hormonal sustitutoria, anticoncepción sistémica (con estrógenos), consumo de tabaco, diabetes, hipercolesterolemia, medicación para la hipertensión o el cáncer
    5.Cardiopatía preexistente (insuficiencia cardíaca congestiva grado III/IV), (véase Apéndice 2: Clasificación funcional de la New York Heart Association (NYHA)), o arritmias que se sabe que conllevan riesgo de episodios tromboembólicos (p. ej., fibrilación auricular).
    6.Evidencia de carcinoma hepatocelular mediante ecografía, TC o RM.
    7.Sujetos con infección por el virus de la inmunodeficiencia humana (VIH) o con infección activa por el virus de la hepatitis B (VHB) (es decir, positividad para el antígeno de superficie de la hepatitis B, HBsAg).
    8.Tratamiento con cualquier terapia antineoplásica o inmunomoduladora menor e igual a 6 meses antes de la primera dosis de eltrombopag. Excepción: no se excluyen las dosis fisiológicas de esteroides o ciclos cortos de esteroides (p. ej., disminución progresiva de esteroides para una exacerbación de asma).
    9.Sujetos con un diagnóstico y/o tratamiento de neoplasia maligna en los últimos 5 años, excepto sujetos con carcinoma basocelular o espinocelular de la piel localizado tratado mediante escisión local o sujetos con neoplasias malignas que han sido tratadas adecuadamente y que, en opinión del oncólogo, tienen una probabilidad excelente de supervivencia sin cáncer.
    10.Mujeres embarazadas o lactantes.
    11.Hombres con una pareja femenina embarazada.
    12.Antecedentes de alcoholismo o abuso de drogas o dependencia en los 6 meses previos al inicio del estudio (a menos que se esté participando en un programa de rehabilitación controlado).
    13.Tratamiento con un fármaco en investigación o IFN dentro de los 30 días o 5 semividas (el valor que sea mayor) anteriores a la visita de selección.
    14.Antecedentes de agregación plaquetaria que impide medir con fiabilidad los recuentos plaquetarios.
    15.Evidencia de trombosis venosa portal en los estudios de imagen abdominales en los 3 meses previos a la visita basal.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluación de la seguridad y la tolerabilidad de eltrombopag según se determine mediante la naturaleza y la frecuencia de acontecimientos adversos, anomalías de laboratorio, exploraciones oculares y vigilancia/observación clínica
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 sujeto, última visita
    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 months4
    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 months4
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 340
    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 Decision2009-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-28
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