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    Summary
    EudraCT Number:2008-000689-21
    Sponsor's Protocol Code Number:MOZ00808
    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 number2008-000689-21
    A.3Full title of the trial
    Plerixafor y G-SCF para la movilización de células madre de sangre periférica para el trasplante autólogo de células madre en pacientes con linfoma no Hodgkin (LNH), enfermedad de Hodgkin (EH) o mieloma múltiple (MM). Estudio de la seguridad del trasplante autólogo en la población general.

    Plerixafor and G-CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients with Non-Hodgkin Lymphoma (NHL), Hodgkin Disease (HD) or Multiple Myeloma (MM) - Safety Study in a General Autologous Transplant Population
    A.4.1Sponsor's protocol code numberMOZ00808
    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 SponsorGenzyme Europe BV
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/227
    D.3 Description of the IMP
    D.3.1Product nameplerixafor
    D.3.2Product code AMD3100
    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 INNPlerixafor
    D.3.9.1CAS number 110078-46-1
    D.3.9.2Current sponsor codeAMD3100
    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.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 Information not present in EudraCT
    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 nameFILGRASTIM
    D.3.2Product code G-CSF
    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 INNFILGRASTIM
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 48
    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 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 Information not present in EudraCT
    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 nameLENOGRASTIM
    D.3.2Product code G-CSF
    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 INNLENOGRASTIM
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number13.4 to 34
    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 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
    Mobilización de células madre a sangre periférica como fase previa al trasplante autólogo de estas células madre en pacientes con Linfoma No-Hodgkin, Enfermedad de Hodgkin o Mieloma Múltiple

    Mobilisation of peripheral blood stem cells prior to autologous stem cell transplantation in patients with Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020206
    E.1.2Term Hodgkin's disease
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Confirmar el perfil de seguridad de plerixafor para movilizar células madre cuando se utiliza en pacientes con linfoma o MM que son elegibles para ser sometidos al tratamiento con trasplante autólogo de células madre hematopoyéticas.

    Confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or multiple myeloma who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant
    E.2.2Secondary objectives of the trial
    - Evaluar la eficacia de plerixafor y del factor estimulante de colonias de granulocitos (por sus siglas en inglés, G-CSF) como tratamiento de movilización, según se determina por el número de células CD34+ recogidas en cada sesión de aféresis.
    - Evaluar la eficacia clínica de las células madre movilizadas por plerixafor y G-CSF mediante el examen de la recuperación de células hematopoyéticas y del estado del injerto.
    - Examinar la influencia de la dosis de células CD34+ perfundida sobre el tiempo hasta la recuperación, en la recuperación y en el estado del injerto.

    - Assess the efficacy of plerixafor and G-CSF as a mobilisation regimen as measured by the number of CD34+ cells collected in each apheresis session
    - Assess the clinical effectiveness of plerixafor and G-CSF mobilised stem cells by examining haematopoietic cell engrafment and graft status
    - Examine the influence of CD34+ cell dose infused on time to engraftment, engraftment and graft status
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Para poder participar en el estudio, los pacientes deberán cumplir los criterios siguientes:
    1. Diagnóstico de MM, LNH o EH en respuesta parcial (RP) o completa (RC).
    2. Elegible y programado para un trasplante autólogo de células madre hematopoyéticas.
    3. Consentimiento informado por escrito.
    4. Tener al menos 18 años.
    5. Grado de actividad del Grupo Oncológico Cooperativo del Este (ECOG) de 0 a 1.
    6. Recuento de leucocitos ?2,5×109/l.
    7. Recuento absoluto de neutrófilos (RAN) ?1,5×109/l.
    8. Recuento de plaquetas ?100×109/l.
    9. Creatinina sérica ?2,2 mg/dl.
    10. Aspartato aminotransferasa/transaminasa glutámico-oxalacética sérica (AST/SGOT), alanina aminotransferasa/transaminasa glutámico-pirúvica sérica (ALT/SGPT) y bilirrubina total <2,5 veces el límite superior normal (LSN).
    11. Función cardiaca, renal y pulmonar adecuadas y suficiente para ser sometido a aféresis y trasplante, es decir, elegible según las normas institucionales para el trasplante autólogo de células madre.
    12. Todos los pacientes deben aceptar el uso de un método anticonceptivo muy eficaz durante el periodo de tratamiento del estudio y durante al menos 3 meses después de finalizar el tratamiento con plerixafor (tanto mujeres en edad fértil como varones cuya pareja se encuentra en esta situación). Los métodos de control de la natalidad eficaces incluyen: a) píldora anticonceptiva, progesterona depot y un dispositivo intrauterino más otro método de barrera o b) dos métodos anticonceptivos de barrera. Los métodos anticonceptivos de barrera eficaces son: preservativos masculinos y femeninos, diafragmas y espermicidas (cremas o geles que contienen un compuesto químico para matar a los espermatozoides). En el caso de las pacientes que usen un método anticonceptivo hormonal, no se tiene información acerca de la interacción de plerixafor con anticonceptivos orales.

    Patients must meet the following criteria to be enrolled in the study:
    1. Diagnosis of MM, NHL, or HD in partial response (PR) or complete response (CR)
    2. Eligible and planned for an autologous haematopoietic stem cell transplantation
    3. Written informed consent
    4. At least 18 years of age (inclusive)
    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
    6. White blood cell (WBC) count > or = 2.5 x 10E9/L
    7. Absolute neutrophil count (ANC) > or = 1.5 x 10E9/L
    8. Platelet count > or = 100 x 10E9/L
    9. Serum creatinine equal or less than 2.2 mg/dL
    10. AST/SGOT, ALT/SGPTn and total bilirubin less than 2.5 x upper limit of normal (ULN)
    11. Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, i.e., eligible by institutional standards for autologous stem cell transplant
    12. All patients must agree to use a highly effective method of contraception whilst on study treatment and for at least 3 months following plerixafor treatments (including both female patients of child-bearing potential and male patients with partners of child-bearing potential). Effective birth control includes: a) birtch control pills, depot progesterone, or an intrauterine device (IUD) plus ne barrier method, or b) tow barrier methods. Effective barrier methods are: male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For patients using a hormonal contraceptive method, information about any interaction of plerixafor with hormonal contraceptives is not known.
    E.4Principal exclusion criteria
    Los pacientes que cumplan cualquiera de los siguientes criterios serán excluidos del estudio:
    1. Antecedentes de cualquier proceso leucémico agudo o crónico (incluyendo síndrome mielodisplásico).
    2. Trasplante alogénico previo o más de un trasplante autólogo previo.
    3. Intentos previos fallidos de recolección de células CD34+ (debido a un rendimiento insuficiente del producto de aféresis o no elegible para aféresis debido a una movilización inadecuada de las células CD34+ en sangre periférica).
    4. Menos de 4 semanas desde el último tratamiento anticancerígeno (incluyendo quimioterapia, biológico/inmunológico o radiación) y menos de 6 semanas si el tratamiento previo fue con nitrosourea o mitomicina (para tratamientos con fármacos de acción prolongada, debe considerarse un intervalo sin tratamiento de al menos 2 veces la semivida del fármaco) con la excepción de:
    - Tratamiento con talidomida, dexametasona, lenalidomida (Revlimid?) y/o bortezomib (Velcade?) que se permite hasta 7 días antes de la primera dosis de G-CSF.
    5. Implicación de la médula ósea >20% evaluada en base a la aspiración o biopsia de médula ósea más reciente.
    6. Tratado con G-CSF u otra citocina durante los 14 días previos a la primera dosis de G-CSF para la movilización.
    7. Positivo para el virus de la inmunodeficiencia humana (VIH).
    8. Hepatitis B o C activa.
    9. Infección aguda (febril, es decir, temperatura >38°C) en las 24 horas previas a la dosificación o tratamiento con antibióticos en los 7 días previos a la primera dosis de G-CSF.
    10. Hipercalcemia manifestada por >1 mg/dl por encima del LSN.
    11. Tratamiento en investigación recibido previamente en las 4 semanas de inclusión en este estudio o participando en otro protocolo de investigación durante la fase de movilización.
    12. Sistema nervioso central afectado con metástasis cerebrales o enfermedad leptomeníngea.
    13. Mujeres embarazadas o en periodo de lactancia.
    14. Electrocardiograma (ECG) o resultado de una prueba (prueba del ejercicio o exploración) indicativo de isquemia cardiaca o antecedentes de alteración del ritmo cardiaco clínicamente significativa (arritmias) u otra anomalía de conducción en el último año que en opinión del investigador justifica la exclusión del paciente del estudio.
    15. Enfermedad comórbida que, en opinión del investigador, pone al paciente en riesgo elevado de complicaciones del tratamiento o altera su capacidad para cumplir el tratamiento y el protocolo del estudio.

    Patients who meet any of the following criteria will be excluded from the study:
    1. History of any acute or chronic leukaemia (including myelodysplastic syndrome)
    2. Prior allogeneic transplantation or more than one prior autologous transplantation
    3. Failed previous CD34+ cell collection attempts (either due to insufficient yield in apheresis product, or ineligible for apheresis because of inadequate mobilisation of CD34+ cells into peripheral blood)
    4. Less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, ratiation) or less than 6 weeks if prior therapy with nitrosourea or mitomycin (for therapies with long-acting agents, a treatment-free interval of at least 2 half-lives should be considered) with the exception of treatment with thalidomide, dexamethasone, lenalidoide (Revlimid R), and/or bortezomib (Velcade R) which is allowed up to 7 days prior to the first dose of G-CSF.
    5. Bone marrow involvement > 20% assessed based on the most recent bone marrow aspirate of biopsy.
    6. Treated with G-CSF or other cytokin within 14 days prior to the first dose of G-CSF for mobilisation.
    7. Known to be HIV positive
    8. Active hepatitis B or hepatitis C
    9. Acute infection (febrile, i.e., temperature > 38ºC) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF.
    10. Hypercalcaemia as evidenced by > 1 mg/dL above ULN
    11. Previously received investigational therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.
    12. Central nerveous system involvement including brain metastases or leptomeningeal disease.
    13. Pregnant or nursing women
    14. Electrocardiogram (ECG) or study result (exercise study, scan) indicative of cardiac ischaemia or a history of clinically significant rhythm disturbances (arrhythmias), or other conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
    15. Co-morbid condition(s), which in the opinion of the investigator renders the patients at high risk from treatment complications or impairs their ability to comply with the study treatment and protocol.
    E.5 End points
    E.5.1Primary end point(s)
    - Número de días hasta la recuperación de neutrófilos y de plaquetas.
    - Aumento del número de células CD34+ en circulación desde las 0 a 10-11 horas después de la primera dosis de plerixafor.
    - Número total de células CD34+ recogidas por tipo de enfermedad.
    - Número total de células CD34+ recogidas por día de aféresis.
    - Estado del injerto (según se determina mediante recuentos trilinaje y tratamiento de apoyo, p. ej., transfusión, G-CSF) a 100 días, 6 meses y 12 meses después del trasplante.

    Efficacy will be based on the quantity of CD34+ cells harvested and the subsequent engraftment and graft status:
    * Number of days to neutrophil engraftment and platelet engraftment
    * Increase in number of circulating CD34+ cells from time 0 to 10-11 hours after the first dose of plerixafor.
    * Total number of CD34+ cells collected by disese type
    * Total number of CD34+ cells collected per apheresis day
    * Graft status (as measured by trilineage counts and supportive treatment, e.g., transfusion, G-CSF) at 100 days, 6 months, and 12 months following transplant
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Después de la participación en el estudio, los pacientes serán tratados de acuerdo con la práctica clínica habitual en cada centro.

    After participation in the trial patients will be treated in accordance with current practice at the particular site.
    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 Decision2009-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-18
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