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    Summary
    EudraCT Number:2011-005155-14
    Sponsor's Protocol Code Number:PKM11204
    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:2012-03-21
    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 number2011-005155-14
    A.3Full title of the trial
    An open-label, pharmacokinetic, pharmacodynamic, and tolerability study of AVE5026 administered at weight-adjusted doses to patients under 18 years of age with a Central Venous Line (CVL)
    Estudio abierto, de farmacocinética y farmacodinámica, y tolerabilidad de AVE5026 administrado en dosis ajustadas al peso a pacientes menores de 18 años con una vía venosa central (VVC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of AVE5026 at weight-adjusted doses in children with a Central
    Venous Line
    Estudio de AVE5026 en dosis ajustadas al peso en niños con una vía venosa central
    A.4.1Sponsor's protocol code numberPKM11204
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/54/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis Recherche et 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 & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointCSU Director
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 5ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 93 485 94 66
    B.5.5Fax number+34 93 489 54 66
    B.5.6E-mailbibiana.figueres@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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSemuloparin sodium
    D.3.2Product code AVE5026
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNsemuloparin sodium
    D.3.9.2Current sponsor codeAVE5026
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeControlled Chemical Heparin depolymerisation
    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 nameSemuloparin sodium
    D.3.2Product code AVE5026
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNsemuloparin sodium
    D.3.9.2Current sponsor codeAVE5026
    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 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) 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 Yes
    D.3.11.13.1Other medicinal product typeControlled Chemical Heparin depolymerisation
    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
    Prevention of thromboembolism
    Prevención de tromboemlismo
    E.1.1.1Medical condition in easily understood language
    Prevention of thromboembolism
    Prevención de tromboemlismo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10043566
    E.1.2Term Thromboembolism
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the pharmacokinetic and pharmacodynamic parameters
    of AVE5026 (assessed from the anti-Xa activity of AVE5026) in
    children in order to determine the dose to be assessed in the
    subsequent clinical efficacy/safety study
    Determinar los parámetros farmacocinéticos y farmacodinámicos de AVE5026 (evaluados a partir de la actividad anti-Xa del compuesto con y sin adición de antitrombina (AT) en el medio reactivo) en niños, para identificar la dosis necesaria para un ensayo de eficacia/seguridad próximo
    E.2.2Secondary objectives of the trial
    To assess the tolerability of AVE5026 when administered at a
    weight-adjusted, once daily dose for up to 30 days
    Evaluar la tolerabilidad de AVE5026 cuando se administra ajustado al peso, una vez al día hasta 30 días
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patient - age between ? 38 gestational weeks and < 18 years
    Central Venous Line implanted for an expected duration ? 6 days from study enrolment
    Patient hospitalized or able to receive daily injection for at least 6 days and provide plasma samples at Day 4, 5 and 6 at the pre-specified time points
    Written informed consent signed by legal representative(s) in accordance with local regulation, and possibly assent form by the child (country/age specific)
    ? Edad: entre ? 38 semanas gestacionales y < 18 años
    ? VVC implantada con una duración prevista de ? 6 días desde la inclusión en el estudio
    ? Hospitalizado o capaz de recibir inyecciones diarias durante al menos 6 días y capaz de proporcionar muestras de plasma durante 3 días (Día 4 a 6)
    ? Consentimiento informado por escrito firmado por el representante o representantes legales de acuerdo con la normativa local y, posiblemente, formulario de asentimiento del niño o adolescente (específico de país/edad)
    E.4Principal exclusion criteria
    Patient for whom anticoagulant therapy is contraindicated
    Planned treatment with other antithrombotic agents within 2 weeks prior to enrolment and during the course of the study
    Any previous exposure to AVE5026 (eg. previous enrolment in the current study)
    Documented history of heparin-induced thrombocytopenia
    Severe thrombocytopenia (platelets < 50 x 10 000 000 000/L)
    Active bleeding
    Recent (less than 3 weeks prior to enrollment) brain, spinal or ophthalmologic surgery
    Uncontrolled hypertension characterized by a sustained systolic pressure or diastolic pressure greater than 2 standard deviations above the age-related norm
    Severe hepatic disease (e.i. more than 2.5 times the upper limit for age of hepatic enzymes)
    Severe renal insufficiency (estimated creatinine clearance < 30 ml/min using the Schwartz formula)
    Any condition that, in the opinion of the Investigator, would expose the patient to an unfavorable risk/benefit ratio
    Presence or history of drug hypersensitivity
    Any patient currently involved in another clinical trial with an investigational drug according to applicable regulations
    Any patient or parent(s)/legal guardian(s) who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development
    Any patient or parent(s)/legal guardian(s) who cannot be contacted in case of emergency
    Pregnant or breast-feeding female
    Female of childbearing potential who are unwilling to abstain from sexual intercourse and therefore are at risk of becoming pregnant and are not protected by highly effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
    E 01. Pacientes en los que el tratamiento con anticoagulantes está contraindicado,

    E 02. Tratamiento programado con otros antitrombóticos en las 2 semanas anteriores a la inclusión y durante el transcurso del estudio,

    E 03. Cualquier exposición previa a AVE5026 (p. ej., inclusión previa en este estudio),

    E 04. Antecedentes documentados de trombocitopenia inducida por heparina,

    E 05. Trombocitopenia severa (plaquetas <50 x 109/l),

    E 06. Hemorragia activa,

    E 07. Cirugía cerebral, vertebral u oftalmológica reciente (menos de 3 semanas antes de la inclusión)

    E 08. Hipertensión no controlada que se caracteriza por una presión arterial sistólica o diastólica mantenida superior a 2 desviaciones estándar por encima de la norma según la edad,

    E 09. Enfermedad hepática severa (es decir, enzimas hepáticas más de 2,5 veces el límite superior de la normalidad correspondiente a la edad),

    E 10. Insuficiencia renal severa (aclaramiento de creatinina estimado < 30 ml/min según la formula de Schwartz (véase el Anexo A),

    E 11. Cualquier afección que, en opinión del investigador, pueda exponer al paciente a una relación riesgo/beneficio desfavorable,

    E 12. Presencia o antecedentes de hipersensibilidad medicamentosa,

    E 13. Cualquier paciente que participe actualmente en otro ensayo clínico con un fármaco en investigación según la normativa aplicable,

    E 14. Cualquier paciente o padre(s)/tutor legal que, en opinión del investigador, es probable que no cumpla durante el estudio, o que sea incapaz de cooperar debido a un problema idiomático o a un retraso mental,

    E 15. Cualquier paciente o padre(s)/tutor legal con el que no se pueda contactar en caso de emergencia.

    E 16. Mujeres embarazadas o en período de lactancia,

    E 17. Mujeres en edad fértil que no estén dispuestas a abstenerse de mantener relaciones sexuales y, por lo tanto, puedan quedar embarazadas, y no utilizan un método anticonceptivo altamente eficaz y/o que no estén dispuestas a realizarse una prueba de embarazo o sean incapaces.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics: Plasma concentrations of AVE5026.
    Individual pharmacokinetic parameters of AVE5026 in children will be derived from a full population PK model building (including covariates assessment).

    Pharmacodynamic activity (anti-Xa activity) of AVE5026.
    Individual pharmacodynamic parameters of AVE5026 in children will be derived from a full population PK/PD model building (including covariates assessment).
    Fármacocinética: Concetraciones plasmáticas de AVE5026. Los parámetros farmacocinéticos individuales de AVE5026 en niños se obtendrán de un modelo FC poblacional completo (incluida la evaluación de las covariables).
    Actividad farmacodinámica (actividad anti-Xa) de AVE5026
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 days
    6 días
    E.5.2Secondary end point(s)
    Safety parameters including bleeding
    Safety parameters including transfusions requirement
    Safety parameters including hemoglobin, platelet count
    Safety parameters including liver and renal laboratory data
    Safety parameters including serious adverse events
    Safety parameters including non-serious adverse events
    Los parámetros de seguridad incluida hemorragia, necesidad de transfusiones, hemoglobina, recuento de plaquetas, datos analíticos hepáticos y renales y acontecimientos adversos (AA) graves o no graves serán monitorizados por el CMD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 30+/- 2 days post treatment
    hasta 30, +/-2 días de después de tratamiento
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial5
    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 EEA10
    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
    Brazil
    Canada
    Guatemala
    Hong Kong
    Hungary
    Israel
    Mexico
    Peru
    Romania
    Russian Federation
    Singapore
    Slovakia
    Spain
    Switzerland
    Turkey
    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
    LVLS
    Última visita del último paciente
    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 months8
    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 months8
    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.1.1Number of subjects for this age range: 44
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 16
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 17
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Depending on age and country.
    Extract from the protocol: "Inclusion criteria number 4: Written informed consent signed by legal representative(s) in accordance with local regulation, and possibly assent form by the child (country/age specific)."
    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 10
    F.4.2.2In the whole clinical trial 44
    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 Decision2012-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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