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    Summary
    EudraCT Number:2011-001847-58
    Sponsor's Protocol Code Number:ARD12042
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-09-19
    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 number2011-001847-58
    A.3Full title of the trial
    A Randomized Phase II, Open-Label study of the Efficacy and Safety of Orally Administered SAR302503 in patients with polycythemia vera (PV) or essential thrombocythemia (ET) who are resistant or intolerant to hydroxyurea
    Estudio en fase II, aleatorizado, abierto sobre la eficacia y seguridad de SAR302503 administrado de forma oral en pacientes con policitemia vera (PV) o trombocitemia esencial (ET) resistentes o intolerantes a hidroxiurea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study with SAR302503 in polycythemia vera or essential thrombocythemia
    Estudio con SAR302503 para policitemia vera (PV) o trombocitemia esencial
    A.4.1Sponsor's protocol code numberARD12042
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportsanofi-aventis recherche and developpement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Pierre Brossolette
    B.5.3.2Town/ cityChilly-Mazarin
    B.5.3.3Post code91385
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)169.74.57.76
    B.5.5Fax number+33(0)169.74.57.30
    B.5.6E-mailedwige.mevel@sanofi-aventis.com
    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/3/10/810 and EU/3/10/811
    D.3 Description of the IMP
    D.3.2Product code SAR302503
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSAR302503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/810 and EU/3/10/811
    D.3 Description of the IMP
    D.3.2Product code SAR302503
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSAR302503
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    polycythemia vera, or essential thrombocythemia
    policitemia vera (PV) o trombocitemia esencial
    E.1.1.1Medical condition in easily understood language
    blood disorder in which the bone marrow makes too many red blood cells, or blood disorder in which the bone marrow makes too many platelets
    Enfermedad de la sangre en la cual la médula osea produce demasiadas glóbulos rojos, o enfermedad de la sangre en la que la médula osea produce demasiadas plaquetas
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10018864
    E.1.2Term Haematopoietic neoplasm NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of daily oral doses of 100, 200 and 400 mg SAR302503 in patients with polycythemia vera and essential thrombocythemia who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for:
    Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and
    Reduction of platelet count to ?400 x 10 exp9/L for a minimum of 3 months in patients with essential thrombocythemia.
    Evaluar la eficacia de dosis orales diarias de 100, 200 y 400 mg de
    SAR302503 en pacientes con PV y TE que son resistentes o intolerantes a hidroxiurea (según los criterios de la European LeukemiaNet) (1,2) para
    ? Inducir la ausencia de flebotomía y un hematocrito por debajo del 45% durante un mínimo de 3 meses en pacientes con PV y
    ? Reducir la recuento de plaquetas a ? 400 x 109/l durante un mínimo de 3 meses en pacientes con TE.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of SAR302503.
    To evaluate the efficacy of daily oral doses of 100, 200 and 400 mg SAR302503 in inducing complete and partial responses (complete response and partial response) per European LeukemiaNet consensus criteria.
    To evaluate the pharmacokinetics of SAR302503 after single and repeat doses.
    To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in those patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition.
    To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life, through serial administration of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF).
    To measure generic health-related quality of life and utility values using the EuroQol Group (EQ-5D?) questionnaire.
    Evaluar la seguridad de SAR302503.Evaluar la eficacia de dosis orales diarias de 100, 200 y 400 mg de SAR302503 para inducir respuestas completas y parciales (respuesta completa y respuesta parcial) conforme a los criterios de consenso de la European LeukemiaNet.Evaluar la farmacocinética de SAR302503 con dosis únicas y repetidas.Evaluar la farmacodinamia de SAR302503 medida por los cambios en la carga alélicas de JAK2V617F en aquellos pacientes con mutación JAK2V617F e inhibición de la fosforilación de STAT3.Medir la mejoría de los síntomas relacionados con neoplasia mieloproliferativa (NMP) en el periodo basal así como el impacto general sobre la calidad de vida, a través de la cumplimentación periódica del Formulario de evaluación de síntomas de la neoplasia mieloproliferativa (Myeloproliferative Neoplasm Symptom Assessment Form, MPN-SAF) (4).
    Medir la calidad de vida relacionada con la salud genérica y los valores de utilidad mediante el cuestionario del Grupo EuroQol (EQ-5D?).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of hydroxyurea resistant or intolerant polycythemia vera (PV) or essential thrombocythemia (ET).
    Polycythemia vera or essential thrombocythemia defined according to the revised WHO criteria
    Polycythemia vera resistance or intolerance to hydroxyurea is defined as polycythemia vera patients on hydroxyurea with a hematocrit >45%, or phlebotomy twice in the last 6 months and at least once in the last 3 months.
    Essential thrombocythemia resistance or intolerance to hydroxyurea is defined as essential thrombocythemia patients on hydroxyurea with platelet count >600 x 10 exp9/L.
    Provide written informed consent to participate.
    I 01. Diagnóstico de PV o TE resistente o intolerante a hidroxiurea.
    ? PV o TE definidos según los criterios revisados de la OMS (6)
    - PV resistente o intolerante a hidroxiurea se define como pacientes con PV tratados con hidroxiurea con un hematocrito >45% o flebotomía dos veces en los últimos 6 meses y al menos una vez en los últimos 3 meses (1).
    - TE resistente o intolerante a hidroxiurea se define como pacientes con TE tratados con hidroxiurea con recuento de plaquetas >600 x 109/l (2).
    I 02. Firma del consentimiento informado por escrito para participar.
    E.4Principal exclusion criteria
    Less than 18 years of age.
    Participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase. (Prior treatment with another JAK2 inhibitor is allowed.)
    Unwilling to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.
    Eastern Cooperative Oncology Group performance status of 3 or 4 at study entry.
    Splenectomy.
    Contraindications for undergoing magnetic resonance imaging in patients with palpable spleens (eg, metal implants).
    Any chemotherapy (eg, hydroxyurea), radiophosphorus therapy, immunomodulatory drug therapy (eg, interferon-alpha), corticosteroids >10 mg/day prednisone or equivalent or anagrelide within 14 days prior to initiation of study drug
    Active malignancy other than PV or ET, except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies that have been stable and off therapy for ?5 years.
    Major surgery within 28 days or radiation within 3 months prior to initiation of study drug.
    Unable to swallow capsules.
    Active acute infection requiring antibiotics.
    Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
    Clinically active hepatitis B or C.
    Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
    Any severe acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with interpretation of study results and, in the Investigator?s opinion, would make the patient inappropriate for entry into this study.
    Inadequate organ function
    Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers CYP3A4, unless approved by the Sponsor.
    Presence of any gastric or other disorder that would inhibit absorption of oral medication.
    Known hypersensitivity to any excipients in the study drug formulation
    Pregnant or lactating female.
    Women of childbearing potential, unless using effective contraception while on study drug.
    Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug.
    E 01. Menor de 18 años de edad.
    E 02. Participación en cualquier estudio de un producto en investigación (fármaco, producto biológico, dispositivo) en los 30 días anteriores al inicio de la administración del fármaco del
    estudio, a menos que sea durante la fase sin tratamiento. (Se permite un tratamiento anterior con otro inhibidor de JAK2.)
    E 03. Falta de disposición para cumplir con las visitas programadas, los planes de tratamiento, las evaluaciones de laboratorio y otros procedimientos relacionados con el estudio.
    E 04. Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 3 o 4 al inicio del estudio.
    E 05. Esperanza de vida de <6 meses.
    E 06. Esplenectomía.
    E 07. Contraindicaciones para someterse a resonancia magnética (RM) en pacientes con bazos palpables (p. ej., implantes metálicos).
    E 08. Cualquier quimioterapia (p. ej., hidroxiurea), terapia con radiofósforo, terapia con fármacos inmunomoduladores (p. ej., interferón-alfa), corticosteroides >10 mg/día de prednisona o equivalente o anagrelida en los 14 días anteriores al inicio del fármaco del estudio
    E 09. Tumor maligno activo distinto a PV o TE, excepto carcinoma de piel basocelular y espinocelular tratados, cáncer de cuello uterino in situ u otros tumores malignos que han sido estables y han estado sin tratamiento durante ?5 años.
    E 10. Cirugía mayor en los 28 días anteriores o radiación en los 3 meses anteriores al inicio del fármaco del estudio.
    E 11. Incapacidad para tragar las cápsulas.
    E 12. Infección aguda activa que requiere antibióticos.
    E 13. Virus de la inmunodeficiencia humana conocido o enfermedad relacionada con el síndrome de inmunodeficiencia adquirida.
    E 14. Hepatitis B o C clínicamente activa.
    E 15. Insuficiencia cardiaca congestiva no controlada (clasificación 3 o 4 de la New York Heart Association), angina de pecho, infarto de miocardio, accidente cerebrovascular, bypass de arteria coronaria / periférica, accidente isquémico transitorio o embolia pulmonar en los 3 meses anteriores al inicio del fármaco del estudio.
    E 16. Cualquier enfermedad médica, neurológica o psiquiátrica grave aguda o crónica o valores analíticos anormales que puedan aumentar el riesgo asociado a la participación en el estudio o la administración del fármaco del estudio, o que pueda interferir con el proceso de consentimiento informado o con el cumplimiento de los requerimientos del estudio o que pueda interferir con la interpretación de los resultados del estudio y que, a juicio del investigador, podría hacer que el paciente no fuera apto para participar en este estudio.
    E 17. Los siguientes valores analíticos en los 14 días anteriores al inicio del fármaco del estudio:
    ? Recuento absoluto de neutrófilos (RAN) < 1,5 × 109/l
    ? Recuento de plaquetas <50 x 109/l
    ? Creatinina sérica >1,5 × límite superior normal (LSN)
    ? Amilasa o lipasa en suero >1,5 × LSN
    E 18. Bilirrubina total >1,5 × LSN
    E 19. Aspartato aminotransferasa o alanina aminotransferasa >3 × LSN (se permiten valores superiores [?5 × LSN] si son clínicamente compatibles con hematopoyesis extramedular hepática).
    E 20. Tratamiento concomitante o uso de fármacos o productos fitoterapéuticos de los que se sabe que al menos son inhibidores o inductores moderados CYP3A4, a menos que estén aprobados por el promotor.
    E 21. Presencia de cualquier trastorno gástrico o de otra índole que podría afectar la absorción de la medicación oral.
    E 22. Hipersensibilidad conocida a cualquier excipiente en la formulación del fármaco del estudio.
    E 23. Mujeres embarazadas o en período de lactancia.
    E 24. Mujeres en edad fértil, salvo que usen un método anticonceptivo eficaz durante el periodo de tratamiento con el fármaco del estudio.
    E 25. Varones cuya pareja femenina esté en edad fértil, a menos que acepten usar un método anticonceptivo eficaz durante el periodo de tratamiento con el fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Polycythemia vera : Proportion of patients with absence of phlebotomy and hematocrit below 45% for a minimum of 3 months after completion of 8 cycles of therapy
    Essential thrombocythemia: Proportion of patients with a platelet count ? 400 x 10 exp9/L for a minimum of 3 months after completion of 8 cycles of therapy.
    ? PV
    Proporción de pacientes sin flebotomía y hematocrito
    por debajo del 45% durante un mínimo de 3 meses
    después de completar los 8 ciclos de tratamiento.
    ? TE
    Proporción de pacientes con una recuento de plaquetas
    ?400 × 109/l durante un mínimo de 3 meses después de completar los 8 ciclos de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    E.5.2Secondary end point(s)
    Characterization of clinicohematologic response defined by European LeukemiaNet sustained for a minimum of 2 months after completion of 8 cycles of therapy.
    Percent change in spleen volume (per Magnetic Resonance Imaging (MRI)) at the end of Cycles 4 and 8 or end of treatment (EOT) relative to baseline.
    Proportion of patients with a 35% reduction in spleen volume (per Magnetic Resonance Imaging (MRI)) at the end of Cycles 4 and 8 or end of treatment (EOT) relative to baseline
    Changes in histological, cytogenetic and molecular responses in bone marrow
    Response (defined as either a 2-point improvement in or resolution of a symptom present at baseline) at the end of Cycles 1, 4, and 8 or end of treatment (EOT), as measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF).
    Caracterización de la respuesta clínico-hematológica definida por la European LeukemiaNet (3), mantenida durante un mínimo de 2 meses después de completar 8 ciclos de tratamiento.
    ? Cambio porcentual del volumen del bazo (por RM) al final de los ciclos 4 y 8 o al final del tratamiento (FdT) respecto al periodo basal.
    ? Proporción de pacientes con una reducción ?35% del volumen del bazo (por RM) al final de los ciclos 4 y 8 o FdT respecto al periodo basal.
    ? Cambios en las respuestas histológicas, citogenéticas y moleculares en la médula ósea (a) en el momento de la respuesta completa en pacientes que logran una respuesta completa y de nuevo 6 meses después si continúan teniendo una respuesta completa y (b) cada 6 meses en pacientes con anomalías citogenéticas o fibrosis reticulínica basales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    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 No
    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 EEA17
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    Not applicable
    No aplica
    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 months3
    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 months3
    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 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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 40
    F.4.2.2In the whole clinical trial 90
    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)
    Not applicable
    No aplica
    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 Decision2011-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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