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    Summary
    EudraCT Number:2010-021377-36
    Sponsor's Protocol Code Number:BO22334
    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:2010-09-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2010-021377-36
    A.3Full title of the trial
    “Estudio de fase III en dos etapas, abierto, internacional, multicéntrico, aleatorizado y controlado para investigar la farmacocinética, la eficacia y la seguridad de rituximab s.c. conjuntamente con CHOP o CVP en comparación a rituximab i.v. conjuntamente con CHOP o CVP en pacientes con linfoma folicular sin tratar previamente, seguido por un tratamiento de mantenimiento bien con rituximab s.c. o bien con rituximab i.v.”
    A two stage phase III, international, multi center, randomized, controlled, open-label study to investigate the pharmacokinetics, efficacy and safety of rituximab SC in combination with CHOP or CVP versus rituximab IV in combination with CHOP or CVP in patients with previously untreated follicular lymphoma followed by maintenance treatment with either rituximab SC or rituximab IV.
    A.4.1Sponsor's protocol code numberBO22334
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namerituximab/rHuPH20 SC
    D.3.2Product code RO0452294/F02
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrituximab/rHuPH20 SC
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRO0452294
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 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 typeAnticuerpo monoclonal humanizado recombinante
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name MABTHERA 100 mg concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameRITUXIMAB
    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 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 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 typeAnticuerpo monoclonal humanizado recombinante
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name MABTHERA 500 mg concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.3Other descriptive nameRITUXIMAB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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 typeAnticuerpo monoclonal humanizado recombinante
    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
    Linfoma Folicular (LF) CD-20 psoitivo grado 1-2, 3a sin tratar previamente
    Previously untreated, CD20-positive follicular lymphoma (FL) grade 1-2, 3a
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10061170
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067070
    E.1.2Term Follicular B-cell non-Hodgkin's lymphoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objetivo principal de la etapa 1
    •Determinar el cociente entre la concentración sérica mínima de rituximab obtenida en el ciclo 7 a los 21 días de la administración subcutánea y la obtenida tras la administración intravenosa (Cmínima, SC/Cmínima, IV en el ciclo 7 del tratamiento de inducción).
    Objetivo principal de la etapa 2
    •Determinar la tasa de respuesta global (TRG, incluyendo RC, RCnc y RP) en cada grupo de tratamiento al final/terminación del tratamiento de inducción.
    E.2.2Secondary objectives of the trial
    Objetivos secundarios de la etapa 1
    •Comparar las AUC de las concentraciones séricas de rituximab observadas (rituximab i.v. frente a s.c.) durante el tratamiento de inducción administrado cada 3 semanas.
    •Explorar parámetros adicionales de PK de rituximab durante el tratamiento de inducción, incluyendo, entre otros, el parámetro farmacocinético previsto para regímenes de inducción administrados cada 4 semanas.
    •Comparar las TRG de rituximab s.c. y rituximab i.v. administrados en combinación con quimioterapia (CHOP o CVP) como tratamiento de inducción al final/terminación del tratamiento de inducción.
    Objetivos secundarios de la etapa 1 y la etapa 2
    •Comparar la reducción y la reposición de linfocitos B en sangre periférica tras el tratamiento con rituximab s.c. y rituximab i.v.
    •Comparar las tasas de respuesta completa (TRC, incluyendo RC y RCnc) de rituximab s.c. y rituximab i.v administrados en combinación con quimioterapia (CHOP o CVP) al final/terminación del tratamient
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Consentimiento informado por escrito y capacidad y voluntad para cumplir el calendario de visitas y las evaluaciones exigidas por el protocolo.
    2.Edad &#8805;18 años.
    3.LNH folicular CD20 positivo confirmado histológicamente, de grado 1, 2 ó 3a según el sistema de clasificación de la OMS. Deberá haberse obtenido una biopsia tumoral (ganglio linfático, médula ósea, etc.) durante los 6 meses previos a la entrada en el estudio, con material disponible para una revisión centralizada.
    4.Sin tratamiento previo. (Nótese que los pacientes diagnosticados en el pasado y tratados con una actitud de “observar y esperar" pueden participar en el ensayo si se sometieron a una biopsia tumoral en los los 6 meses anteriores que esté disponible para la revisión centralizada).
    5.Pacientes con al menos uno de estos signos y síntomas que necesite tratamiento:
    a)Enfermedad voluminosa definida como una masa ganglionar o extraganglionar (excepto el bazo) &#8805; 7 cm en su diámetro mayor.
    b)Síntomas B.
    c)LDH o beta-2-microglobulina séricas elevadas.
    d)Afectación de al menos 3 localizaciones ganglionares (cada una de ellas con un diámetro mayor de 3 cm).
    e)Esplenomegalia sintomática.
    f)Síndrome compresivo.
    g)Derrame pleural/peritoneal.
    6.Estado funcional del ECOG de 0-2.
    7.Esperanza de vida de 6 meses o más.
    8.Enfermedad mensurable en dos dimensiones (mensurable mediante TAC o RM).
    9.Las mujeres premenopáusicas y las mujeres menopáusicas en las que el inicio de la menopausia se haya producido hace menos de 2 años deberán tener un resultado negativo en la prueba de embarazo en suero 1 semana antes del tratamiento, o 14 días antes, en cuyo caso se hará una prueba de confirmación de embarazo en orina dentro de la semana anterior al inicio del tratamiento del estudio.
    10.Función hematológica adecuada en los 28 previos a la aleatorización (excepto si se relaciona con infiltración del linfoma en la médula ósea):
    a)Hemoglobina (Hb) &#8805; 8,0 g/dl (5 mmol/l).
    b)Recuento absoluto de neutrófilos (RAN) &#8805; 1,5 x 109/l.
    c)Recuento de plaquetas &#8805; 100 x 109/l.
    E.4Principal exclusion criteria
    1.Linfoma folicular de grado 3b.
    2.Transformación en linfoma de alto grado secundario a linfoma folicular.
    3.Tipos de LNH distintos del linfoma folicular, según la clasificación de la OMS.
    4.Presencia o antecedentes de enfermedad del SNC (linfoma del SNC o meningitis linfomatosa).
    5.Tratamiento con corticosteroides durante las últimas 4 semanas, salvo si la dosis fue inferior al a 20 mg/día de equivalente de prednisona.
    6.Presencia o antecedentes de neoplasias malignas diferentes del linfoma folicular. (En general, son elegibles los pacientes con antecedentes de carcinoma basocelular o epidermoide de la piel tratado con intención curativa, o carcinoma in situ del cuello uterino, o cualquier otro cáncer para el cual el paciente haya presentado remisión completa durante al menos 5 años).
    7.Intervención de cirugía mayor en los 28 días previos a la entrada en el estudio (la biopsia de ganglios linfáticos no se considera un procedimiento de cirugía mayor).
    8.Mujeres embarazadas o en período de lactancia.
    9.Varones o mujeres en edad fértil si no se comprometen a utilizar un método anticonceptivo eficaz durante todo el estudio y durante al menos 12 meses tras la última dosis de rituximab.
    10.Cualquiera de los valores analíticos anómalos siguientes:
    a)Creatinina sérica > 2 mg/dl (197 µmol/l).
    b)Bilirrubina total > 1,5 veces el límite superior de la normalidad.
    c)Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) > 2,5 veces el límite superior de la normalidad (o > 5 veces el límite superior de la normalidad en presencia de afectación hepática).
    11.Infección activa o antecedentes de infección por el virus de la hepatitis B o C (se excluirá a los pacientes con signos serológicos de exposición actual o previa al VHB, a no ser que los resultados serológicos se deban claramente a la vacunación).
    12.Infección conocida por el VIH.
    13.Infección activa conocida de origen bacteriano, viral, fúngico o micobateriano, o cualquier episodio importante de infección que exija hospitalización o tratamiento con antibióticos i.v. durante las 4 semanas previas a la selección, o antibióticos orales durante las 2 semanas previas a la selección.
    14.Antecedentes de trasplante de órganos incluido el trasplante de células madre hematológicas.
    15.Enfermedades concomitantes no controladas que puedan afectar al cumplimiento del protocolo o a la interpretación de los resultados, tales como enfermedad cardiovascular importante (enfermedad cardíaca de clase III o IV de la New York Heart Association, infarto de miocardio en los 6 últimos meses, arritmias inestables o angina inestable) o enfermedad pulmonar (enfermedad pulmonar obstructiva o antecedentes de broncoespasmo sintomático).
    16.Hipersensibilidad conocida a productos de origen murino, o a los otros fármacos del estudio o sus componentes.
    17.Tratamiento actual o reciente con otro fármaco en investigación o participación en otro estudio clínico experimental durante los 30 días anteriores a la entrada en el estudio.
    18.Cualquier otro trastorno médico o psicológico que suponga una contraindicación al uso de un fármaco en investigación, impida la recogida apropiada de los datos del estudio, o afecte a la capacidad del paciente para otorgar su consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Variable principal de la etapa 1
    •Cociente calculado entre las concentraciones séricas mínimas de rituximab observadas (Cmínima SC/Cmínima IV), en el ciclo 7 del tratamiento de inducción administrado cada 3 semanas.
    Variable principal de la etapa 2
    •TRG calculada en cada grupo de tratamiento al final/terminación del tratamiento de inducción.
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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
    El final del estudio se define como la fecha de la última visita de seguimiento del último paciente en seguimiento. Tendrá lugar aproximadamente 54 meses después de que el último paciente incluido reciba el primer tratamiento del estudio, o antes, si todos los pacientes presentan progresión de la enfermedad, fallecen o se retiran del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 530
    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 Decision2010-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-23
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