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    Summary
    EudraCT Number:2008-006873-33
    Sponsor's Protocol Code Number:A4001031
    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:2009-01-19
    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 number2008-006873-33
    A.3Full title of the trial
    ENSAYO ABIERTO, MULTICÉNTRICO, DE FARMACOCINÉTICA POR ADMINISTRACIÓN DE DOSIS MÚLTIPLES Y DE SEGURIDAD Y EFICACIA DE 48 SEMANAS DE MARAVIROC EN COMBINACIÓN CON UN TRATAMIENTO DE BASE OPTIMIZADO PARA EL TRATAMIENTO DE NIÑOS Y JÓVENES DE 2 A 18 AÑOS INFECTADOS POR EL VIH-1 CON TROPISMO CCR5 Y QUE YA HAN RECIBIDO TRATAMIENTO CON ANTIRRETROVIRALES
    AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC AND 48-WEEK SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2-18 YEARS OF AGE
    A.4.1Sponsor's protocol code numberA4001031
    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 SponsorPfizer, S.A.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form 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 INN4,4-difluoro-N...
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK427,857
    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 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form 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 INN4,4-difluoro-N...
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK427,857
    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 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 nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form 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 INN4,4-difluoro-N...
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK427,857
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form Oral solution
    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 INN4,4-difluoro-N...
    D.3.9.1CAS number 376348-65-1
    D.3.9.2Current sponsor codeUK427,857
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tratamiento VIH
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Determinar las características farmacocinéticas y las pautas de administración para el maraviroc en niños y adolescentes con infección por el VIH tratados previamente que están recibiendo diferentes tratamientos de base.
    •Determinar la seguridad y la tolerabilidad del maraviroc en niños y adolescentes infectados por el VIH.
    E.2.2Secondary objectives of the trial
    •Describir la eficacia de la administración de dosis múltiples de maraviroc en niños infectados por el VIH 1 con tropismo CCR5 tratados previamente.
    •Describir las variaciones del tropismo con el tiempo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Entrega del documento de consentimiento informado por escrito firmado y fechado, indicando que el sujeto (o su representante legal) ha sido informado de todos los aspectos pertinentes del estudio.
    2.Sujetos de 2 18 años de edad que estén disponibles para un período de seguimiento de al menos 48 semanas.
    3.Los sujetos deberán estar dispuestos y ser capaces de cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio .
    4.ARN del VIH 1 &#8805; 1.000 copias/ml determinado con el análisis del VIH 1 COBAS AmpliPrep/COBAS TaqMan de Roche.
    5.El sujeto ha estado recibiendo un tratamiento ARV estable previo al estudio durante al menos 4 semanas antes de la visita de selección o no ha tomado ningún tratamiento ARV como mínimo en las 4 semanas anteriores a la visita de selección.
    • Si el sujeto ya está recibiendo tratamiento ARV antes de la visita de selección, no deben haberse cambiado los fármacos ARV del tratamiento en el período previo de 4 semanas. Sin embargo, se permite el cambio de dosis (por el aumento de peso) y el cambio en la formulación del fármaco ARV. Los sujetos tendrán que seguir con el mismo tratamiento durante el periodo de selección.
    • Sujetos que no cambien el tratamiento ARV durante al menos 4 semanas antes del período de selección y que experimenten un fracaso virológico (definido como una concentración plasmática de ARN del VIH 1 &#8805; 1.000 copias/ml).
    6.Tratamiento previo/intolerancia &#8805; 6 meses (secuencial o acumulada) con al menos dos grupos de ARV.
    7.Disposición para continuar el tratamiento sin cambios ni adiciones al TBO, salvo para el tratamiento de toxicidad o si se cumplen los criterios de fracaso virológico.
    8.Las mujeres con capacidad de procrear (MCP), deben presentar una prueba de embarazo en orina negativa en la visita basal antes de recibir la primera dosis de la medicación del estudio.
    NOTA: Se define como MCP a todas aquellas mujeres que han experimentado la menarquia y que no se han sometido a una esterilización quirúrgica con éxito ni son posmenopáusicas (es decir, no han menstruado en los últimos dos años). Deberán considerarse mujeres con capacidad de procrear incluso aquellas que estén utilizando anticonceptivos hormonales orales, implantes o inyectables o anticonceptivos hormonales o mecánicos (dispositivos intrauterinos, métodos de barrera como el preservativo y el diafragma con un espermicida) para prevenir el embarazo, que practiquen la abstinencia sexual o cuya pareja sea estéril (p. ej., vasectomía).
    9.Uso de un método anticonceptivo de barrera eficaz en las MCP y en los varones. Además, las MCP deben utilizar otro método anticonceptivo aceptable durante el estudio y hasta 28 días después de la última dosis de maraviroc. Los anticonceptivos aceptables son, entre otros, el tratamiento hormonal oral, implante o inyectable y los dispositivos intrauterinos.
    E.4Principal exclusion criteria
    1.Sujetos que requieran tratamiento con más de 5 fármacos ARV en el TBO (el ritonavir en dosis bajas no se considera un ARV aparte).
    2.Tratamiento previo con maraviroc, con otro antagonista del receptor CCR5 o con otro inhibidor experimental de la entrada del VIH durante más de 14 días.
    3.Antecedentes de un cumplimiento pobre de la medicación, alcoholismo o toxicomanía activos suficientes para impedir la adherencia de la medicación del estudio y/o el seguimiento.
    4.Quimioterapia sistémica actual o antecedentes de neoplasias malignas.
    5.Mujeres lactantes o que tengan previsto quedarse embarazadas durante el período del estudio.
    6.Sospecha o confirmación de una infección oportunista relacionada con el VIH 1 activa no tratada o de otro trastorno que requiera tratamiento agudo (p. ej., infección por el virus de la hepatitis C) en la visita basal.
    NOTA: Los sujetos que estén recibiendo un tratamiento profiláctico de infecciones oportunistas (IO) secundarias estable (> 1 mes) o un tratamiento crónico (p. ej., contra la hepatitis C) son elegibles para participar en el estudio. Los sujetos que estén recibiendo un tratamiento profiláctico de IO primarias de cualquier duración también son elegibles para participar en el estudio.
    7.Tratamiento para una infección oportunista activa o fiebre idiopática > 38,5 °C durante 7 días consecutivos, en los 30 días previos a la visita basal.
    8.Hipersensibilidad conocida o antecedentes de alergia a algún componente del maraviroc, incluida la lecitina de soja o los cacahuetes.
    9.Inicio de un tratamiento con un fármaco potencialmente mielodepresor, neurotóxico, hepatotóxico y/o citotóxico en los 60 días previos a la visita basal, o necesidad prevista de dicho tratamiento durante el período del estudio.
    10.Pancreatitis o hepatitis aguda confirmada o presunta en los 30 días previos a la visita basal.
    11.Anomalía conocida de grado &#8805; 3 en cualquiera de las siguientes pruebas analíticas en el período de selección o en los 30 días previos a la visita basal:
    •recuento de neutrófilos, hemoglobina, plaquetas, AST, ALT, creatinina y lipasa.
    NOTA: Los sujetos que presenten una variación de dos o más grados en la AST o la ALT entre las visitas de selección y basal deberán ser revisados por Pfizer.
    •Bilirrubina total de grado &#8805; 3, a menos que se cumplan TODAS las condiciones siguientes:
    •El tratamiento actual incluye atazanavir.
    •ALT/AST &#8804; 2,5 x LSN.
    •Ausencia de síntomas excepto ictericia.
    NOTA: Los sujetos que presenten una variación de dos o más grados en la bilirrubina directa entre las visitas de selección y basal deberán ser revisados por Pfizer.
    •Otros valores analíticos de grado &#8805; 3 deberán ser revisados por Pfizer.
    12.Antecedentes de acidosis láctica en los tres meses previos a la visita de selección. La acidosis láctica se define como:
    •Concentración confirmada de lactato &#8805; 2 x LSN en sujetos con valores de ALT y AST > 2,5 x LSN sin una etiología fácilmente discernible (p. ej. hepatitis A, B o C aguda o hepatitis B o C crónica).
    O
    •Náuseas idiopáticas nuevas y persistentes, vómitos, dolor abdominal, distensión abdominal, fatiga idiopática y disnea.
    13.Cirrosis.
    14.Síndrome de malabsorción clínicamente significativo (> 6 deposiciones de heces sueltas al día, durante al menos 7 días consecutivos) en los 30 días previos a la visita basal.
    15.Detección del virus con tropismo X4 o doble/mixto mediante el análisis de tropismo viral TrofileTM o fracaso repetido del análisis.
    16.Tratamiento concomitante con otros fármacos experimentales (excepto fármacos ARV experimentales disponibles a través de programas de acceso previo a la aprobación del medicamento).
    17.Medicamentos contraindicados que deben continuarse durante el período del estudio.
    18.Cualquier razón relacionada con la seguridad, relacionada con el comportamiento, clínica o administrativa que, en opinión del investigador, podría comprometer el cumplimiento del estudio o la capacidad de evaluar la seguridad o la eficacia.
    19.Uso de una sonda de gastrostomía para la administración del maraviroc. (Pueden administrarse otros medicamentos a través de la sonda de gastrostomía.)
    E.5 End points
    E.5.1Primary end point(s)
    •Farmacocinética: parámetro FC del maraviroc, concentración promedio (Cavg).
    •Seguridad: acontecimientos adversos de grado &#8805;3, suspensiones del tratamiento secundarias a AAG relacionados con el fármaco del estudio.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    EOT is LSLV at the end of the follow-up period
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 125
    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 Decision2009-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
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