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    Summary
    EudraCT Number:2008-007038-24
    Sponsor's Protocol Code Number:A4001078
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-03-24
    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 number2008-007038-24
    A.3Full title of the trial
    "Estudio piloto de una nueva combinación de maraviroc + atazanavir/ritonavir frente a atazanavir/ritonavir + emtricitabina/tenofovir para el tratamiento de pacientes con infección por VIH del tipo VIH-1 R5 no tratados previamente"


    "PILOT STUDY OF NOVEL COMBINATION OF MARAVIROC +ATAZANAVIR/RITONAVIR VS ATAZANAVIR/RITONAVIR +EMTRICITABINE/TENOFOVIR FOR THE TREATMENT OF TREATMENT NAÏVE HIV-INFECTED PATIENTS WITH R5 HIV-1"
    A.4.1Sponsor's protocol code numberA4001078
    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 Yes
    D.2.1.1.1Trade name CELSENTRI 150 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER 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 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 INNMARAVIROC
    D.3.9.3Other descriptive nameMARAVIROC
    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: 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 TRUVADA 200 mg/245 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderGILEAD SCIENCIES INTERNATIONAL LTD.
    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 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 INNEMTRICITABINA
    D.3.9.3Other descriptive nameEMTRICITABINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR
    D.3.9.3Other descriptive nameTENOFOVIR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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 Yes
    D.2.1.1.1Trade name REYATAZ 300 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL MYERS SQUIBB PHARMA EEIG
    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 Capsule, hard
    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 INNATAZANAVIR
    D.3.9.3Other descriptive nameATAZANAVIR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Yes
    D.2.1.1.1Trade name NORVIR 100 mg cápsulas blandas
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT LABORATORIES LTD.
    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 Capsule, soft
    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 INNRITONAVIR
    D.3.9.3Other descriptive nameRITONAVIR
    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 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 de pacientes con infección por VIH del tipo VIH-1 R5"
    TREATMENT OF TREATMENT NAÏVE HIV-INFECTED PATIENTS WITH R5 HIV-1
    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
    Examinar si la combinación de maraviroc (SelzentryTM CelsentriR) y atazanavir /ritonavir es efectiva para el tratamiento de pacientes. infectados por VIH sin experiencia de tratamiento, mediante el porcentaje de sujetos con un nivel de VIH-1 ARN inferior al límite de detección de la prueba (<50 copias de VIH-1 ARN por mililitro de plasma) a las 48 semanas.
    E.2.2Secondary objectives of the trial
    1.-Seguridad y tolerabilidad;
    2.-Valorar la cinética viral en las 2 primeras semanas de los 15 primeros pacientes de cada grupo de tratamiento (sólo en pacientes de los EUA);
    3.-Evaluar la farmacocinética de maraviroc en un subgrupo de pacientes (n=15) incluidos en el grupo de tratamiento de maraviroc;
    4.-Valorar la respuesta virológica a lo largo del tiempo;
    5.-Valorar la respuesta inmunológica (recuentos de CD4 y CD8) a lo largo del tiempo;
    6.-Examinar la evolución de la resistencia viral y/o tropismo, sólo en pacientes con fracaso terapéutico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.- Documento de consentimiento informado firmado y fechado indicando que el paciente (o su representante legal) ha sido informado de todos los aspectos pertinentes del ensayo.
    2.- Edad mínima de 16 años de edad (o la edad mínima determinada por las autoridades sanitarias locales o de acuerdo a los requerimientos legales) en la Visita de selección.
    3.- Carga viral VIH-1 ARN &#8805;1.000 copias/mL determinada en la Visita de selección.
    4.- Recuento de CD4 &#8805;100 células /mm3 en la selección.
    5.- Presentar solamente VIH-1 R5 en la selección, verificado mediante el test Monogram Bioscience Trofile&#61652; de sensibilidad elevada.
    6.- Prueba de embarazo en orina negativa en la Visita basal, antes de recibir la primera dosis de medicación de estudio, para las mujeres potencialmente fértiles (MPF).
    NOTA: Entre las MPF se incluye cualquier mujer que haya presentado la menarquia y no haya sido sometida a cirugía de esterilización con éxito ni sea posmenopáusica (es decir, sin menstruaciones durante un mínimo de 2 años). Se considerarán fértiles incluso aquellas mujeres que usen una contracepción hormonal oral, implantada o inyectable, o productos mecánicos (dispositivos intrauterinos; métodos de barrera: preservativo o diafragma con espermicida) para prevenir el embarazo, que practiquen la abstinencia o cuya pareja sea estéril (Ej. vasectomía).
    7.- Contracepción de barrera efectiva para las MPF. Además, las MPF deberán usar otro método de contracepción aceptable durante todo el estudio. Una contracepción aceptable incluye, aunque no solamente, la terapia hormonal oral, implantada o inyectable, y los dispositivos intrauterinos.
    8.- Deseo y capacidad de cumplir con las visitas programadas, plan de tratamiento, analíticas y otros procedimientos de estudio.
    E.4Principal exclusion criteria
    1.- Sospecha o documentación de infección oportunista (IO) activa asociada a VIH-1 no tratada u otra patología que requiera tratamiento agudo en el momento de la Aleatorización [Los pacientes con un régimen de profilaxis secundaria de la IO estable (>1 mes) o tratamiento crónico con enfermedad estable (Ej. infección por el virus de la hepatitis C) serán elegibles para el estudio; los pacientes con un régimen de profilaxis primaria de la IO de cualquier duración también serán elegibles para el estudio].
    2.- Tratamiento por infección oportunista activa o temperatura >38,5°C (101,3º F) inexplicable durante 7 días consecutivos en los 30 días anteriores a la Aleatorización.
    3.- Tratamiento previo con cualquier otra terapia antirretroviral para el VIH durante más de 14 días en cualquier momento.
    4.- Abuso del alcohol o de drogas activo suficiente, en opinión del investigador, para impedir la adherencia a la medicación de estudio y/o el Seguimiento.
    5.- Embarazo, lactancia o planes de quedar embarazada.
    6.- Sospecha de infección primaria (aguda) por VIH-1.
    7.- Inicio de una terapia con un fármaco potencialmente mielosupresor, neurotóxico, hepatotóxico y/o citotóxico en los 60 días anteriores a la Aleatorización o previsión de necesidad de dicha terapia durante el periodo de estudio. NOTA: En los 60 días anteriores a la Aleatorización no podrá iniciarse tratamiento con trimetoprima-sulfametoxazol, pero si el paciente está tomando tratamiento estable podrá continuarlo.
    8.- Neoplasia que requiera quimioterapia parenteral y que deba proseguir durante todo el ensayo.
    9.- Documentación o sospecha de hepatitis o pancreatitis aguda en los 30 días anteriores a la Aleatorización.
    10.- Insuficiencia renal definida como creatinina sérica superior a 3 veces el límite superior de la normalidad o aclaramiento de creatinina inferior a 50 mL/min, calculado mediante la ecuación de Cockcroft y Gault (Apéndice 1).
    11.- Bilirrubina total superior a 2 veces el límite superior de la normalidad. Los cambios de uno o más grados en la bilirrubina total entre las visitas de Selección y de Aleatorización deberán ser revisados con el monitor médico de Pfizer antes de iniciar la medicación de estudio.
    12.- AST y/o ALT superior a 3 veces el límite superior de la normalidad. Los cambios de uno o más grados en los resultados de las PFH entre la Selección y la Aleatorización deberán ser revisados con el monitor médico de Pfizer antes de iniciar la administración de las medicaciones de estudio.
    13.- Cirrosis hepática, insuficiencia hepática moderada o grave (B o C en la clasificación Child-Pugh).
    14.- Antígeno de superficie de la hepatitis B positivo.
    15.- Recuento absoluto de neutrófilos &#8804;750 células /mm3.
    16.- Recuento plaquetar &#8804;50.000 células /mm3.
    17.- Hemoglobina &#8804;7 g/dL.
    18.- Síndrome de malabsorción clínicamente significativo en los 30 días anteriores a la Aleatorización.
    19.- Incapacidad para tolerar medicación oral.
    20.- Tratamiento concomitante con otros fármacos en investigación.
    21.- Medicación contraindicada que el paciente esté tomando en el momento de la Aleatorización y que deba continuar tomando durante el periodo de estudio, como inmunomoduladores (para el tratamiento de la infección por VIH-1;), y cualquier medicación contraindicada descrita en los prospectos de maraviroc (SelzentryTM, CelsentriR), atazanavir (ReyatazTM), ritonavir (NorvirTM) y emtricitabina /tenofovir (TruvadaR).
    22.- Evidencia de resistencia a atazanavir, tenofovir y emtricitabina.
    23.- Virus X4-o de tropisno dual /mixto mediante el test TrofileTM más sensible, fracaso de la repetición del test o resultados no notificables.
    24.- Cualquier problema por razones de seguridad, conducta, clínicas o administrativas que, a criterio del investigador y potencialmente, pudiera comprometer el cumplimiento del estudio o la capacidad de evaluar la seguridad /eficacia.
    25.- Alteración analítica o patología médica de peligro vital potencial (Grado 4) (según la tabla de División del SIDA para clasificar la intensidad de las experiencias adversas en el adulto. Los pacientes con elevación es Grado 4 de los triglicéridos, colesterol o CPK serán elegibles para el estudio.
    26.- Presentar hipersensibilidad conocida a atazanavir, ritonavir, tenofovir, emtricitabina y maraviroc o alguno de sus excipientes, incluida la lecitina de soja o las tinciones de estos fármacos descritas en sus prospectos.
    27.- Participación en otros estudios antes de que se inicie el estudio actual y/o durante la participación en el estudio.
    28.- Otras patologías severas agudas o crónicas, médicas o psiquiátricas o alteraciones analíticas que puedan incrementar el riesgo de la participación en el estudio o la administración del fármaco de estudio, o que puedan interferir la interpretación de los resultados del estudio, y que a juicio del investigador hicieran que la inclusión del paciente no fuera adecuada.
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de pacientes con <50 copias/mL de VIH-1 ARN plasmático en cada grupo de tratamiento a las 48 semanas.
    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
    Tolerabilidad
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days20
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 88
    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 Decision2009-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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