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    Summary
    EudraCT Number:2009-014696-52
    Sponsor's Protocol Code Number:17P-ES-003
    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:2009-12-01
    Trial 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 number2009-014696-52
    A.3Full title of the trial
    A PHASE 3B, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF HYDROXYPROGESTERONE CAPROATE INJECTION, 250 MG/ML, VERSUS VEHICLE FOR THE PREVENTION OF PRETERM BIRTH IN WOMEN WITH A PREVIOUS SINGLETON SPONTANEOUS PRETERM DELIVERY /

    ESTUDIO DE FASE 3B, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, DE CAPROATO DE HIDROXIPROGESTERONA INYECTABLE, 250 MG/ML FRENTE AL VEHÍCULO, PARA LA PREVENCIÓN DEL PARTO PREMATURO EN MUJERES CON UN PARTO ÚNICO PREMATURO ESPONTÁNEO PREVIO
    A.4.1Sponsor's protocol code number17P-ES-003
    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 SponsorHologic, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name17P
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhydroxyprogesterone caproate
    D.3.9.1CAS number 630-56-8
    D.3.9.3Other descriptive name17alpha-hydroxyprogesterone caproate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Premature Birth /

    Parto Prematuro
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10036594
    E.1.2Term Premature birth
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es determinar si el tratamiento con 17P reduce la tasa de partos prematuros de < 35 semanas de gestación en mujeres con un embarazo único, mayores de 18 años, con un parto único prematuro espontáneo previo
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son:
    o Determinar si 17P reduce la tasa de mortalidad o morbilidad neonatal, si y sólo si, la tasa de partos pretérmino de < 350 semanas de gestación es estadísticamente significativa (esto es, enfoque de prueba jerárquico). La mortalidad o morbilidad neonatal se mide por un índice compuesto, que comprende:
    - Muerte neonatal.- Hemorragia intraventricular de grado 3 ó 4.- Síndrome de distrés respiratorio.- Displasia broncopulmonar.- Enterocolitis necrotizante.
    - Sepsis demostrada
    o Descartar una duplicación del riesgo de la mortalidad fetal/neonatal precoz, en el grupo de 17P vs. el grupo de vehículo
    o Determinar si 17P reduce: la tasa de partos prematuros de < 32 semanas de gestación;la tasa de partos prematuros de < 37 semanas de gestación;la tasa de mortinatos y la tasa de muerte neonatal producida en nacidos vivos tras 24 semanas o mas de gestación.
    Evaluar la farmacocinética/farmacodinámia (FC/FD) de 17P en un subgrupo de embarazadas.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    El protocolo principal(17P-ES-003) incluye un subestudio FC.
    Se puede ofrecer a las pacientes la oportunidad de participar en un subestudio farmacocinético hasta que se hayan reclutado a aproximadamente 450 pacientes (300 con tratamiento activo y 150 con vehículo). Se realizarán evaluaciones farmacocinéticas basadas en un muestreo escaso según el IMC previo a embarazo, para analizar la relación dosis-concentración plasmática-tiempo de HPC
    E.3Principal inclusion criteria
    Cada paciente debe cumplir los siguientes criterios para ser seleccionada en el estudio:
    1.Edad > o igual 18 años.
    2.Gestación única.
    3.Edad gestacional proyectada de 16 semanas de gestación o más y menor o igual a 20 semanas de gestación en el momento de la aleatorización, de acuerdo con la información clínica y la evaluación de la primera ecografía, tal y como se describe más adelante en la "Determinación de la edad gestacional".
    4.Antecedente documentado de un parto único prematuro espontáneo previo. El parto prematuro espontáneo se define como el parto desde las 20 a las 36 semanas de gestación después de un inicio espontáneo de labor de parto o RPMp. Siempre que sea posible, se debe determinar la edad gestacional del parto prematuro anterior (demominado parto cualificador), tal y como se describe más adelante en la "Determinación de la edad gestacional". Si la edad gestacional se obtiene directamente de la historia clínica y aparece más de una edad gestacional, se utilizará la última. Como validación de la edad gestacional del parto previo, si el lactante pesó más de 3.300 gramos (el percentil 90 de peso al nacer para una edad gestacional de 36 semanas), no se considerará prematuro. El parto prematuro previo no puede ser un mortinato anteparto
    E.4Principal exclusion criteria
    1. Gestación multifetal.
    2. Anomalía fetal importante o muerte fetal conocidas. Debe realizarse una exploración ecográfica entre las 14 y las 20 semanas de gestación para descartar anomalías fetales.
    3. Tratamiento con progesterona de cualquier forma (esto es, vaginal, oral, intramuscular) durante el embarazo actual.
    4. Tratamiento con heparina durante el embarazo actual o antecedentes de enfermedad tromboembólica.
    5. Complicaciones médicas/obstétricas maternas, incluyendo:
    - Cerclaje actual o programado
    - Hipertensión que precisa medicación
    - Trastorno convulsivo
    6. Las pacientes con una anomalía uterina (útero didelfo o útero bicornato). Sin embargo, las pacientes con fibromas uterinos son elegibles para el estudio.
    7. Falta de voluntad para cumplir con los requisitos y finalizar el estudio.
    8. No se puede fijar una ecografía entre las 14 y las 20 semanas de gestación, antes de la aleatorización.
    9. Participación en un estudio antenatal en el que el estado clínico o la intervención podrían influir en la edad gestacional en el momento del parto.
    10. Participación en este ensayo en un embarazo previo. Las mujeres que se sometieron a selección en un embarazo previo, pero no fueron aleatorizadas, no tienen que excluirse.
    11. Hipersensibilidad conocida a caproato de hidroxiprogesterona o a sus componentes.
    12. Tener cualquier trastorno médico significativo que, en opinión del investigador, sería una contraindicación para el uso del fármaco, incluyendo aquellos enumerados en la sección 5.3.2 del manual del investigador. Otros ejemplos a considerar son diabetes no controlada, infección por VIH conocida o disfunción renal.
    13. Tener cualquier trastorno médico significativo que, en opinión del investigador, impediría la evaluación exacta del estado de la paciente o del resultado del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es el parto prematuro antes de las 35 semanas de gestación (determinado por la edad gestacional proyectada). Se incluirán todos los partos que se produzcan desde la aleatorización hasta las 35 semanas de gestación, incluidos los abortos que se produzcan desde las 160 hasta las 19 semanas de gestación y los abortos terapéuticos
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.3Pregnant women Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 725
    F.4.2.2In the whole clinical trial 1707
    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 Decision2010-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-08
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