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    Summary
    EudraCT Number:2020-000500-10
    Sponsor's Protocol Code Number:NeoCirc003
    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:2020-03-06
    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 number2020-000500-10
    A.3Full title of the trial
    An international multicentre randomized placebo-controlled, double blind three arm trial to investigate the efficacy of dobutamine with two different starting doses in the treatment of haemodynamic insufficiency in the immediate postnatal period
    Un ensayo internacional multicéntrico aleatorizado, controlado con placebo, doble ciego de tres brazos para investigar la eficacia de la dobutamina con dos dosis iniciales diferentes en el tratamiento de la insuficiencia hemodinámica en el período posnatal inmediato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of dobutamine in neonates with haemodynamic insufficiency
    Eficacia de la dobutamina en neonatos con insuficiencia hemodinámica.
    A.3.2Name or abbreviated title of the trial where available
    Neocirculation 003
    A.4.1Sponsor's protocol code numberNeoCirc003
    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 SponsorServicio Madrileño de Salud (SERMAS) Fundación para la Investigación Biomédica Hospital Universitario La Paz (FIBHULP)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCICEC
    B.5.2Functional name of contact pointIrene García
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number0034912071466
    B.5.5Fax number0034912071466
    B.5.6E-mailirene.ucicec@gmail.com
    D. IMP Identification
    D.IMP: 1
    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 Dobutamine Hospira
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA INVICTA, S.A.
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    Intravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOBUTAMINE
    D.3.9.1CAS number 34368-04-2
    D.3.9.4EV Substance CodeSUB06343MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Babies with evidence of haemodynamic insufficiency within 72 hours after birth
    Bebés con evidencia de insuficiencia hemodinámica dentro de las 72 horas posteriores al nacimiento.
    E.1.1.1Medical condition in easily understood language
    babies within 72 hours after birth with circulatory failure causing insufficient blood to reach important organs
    bebés dentro de las 72 horas posteriores al nacimiento con insuficiencia circulatoria que hace que la sangre insuficiente llegue a órganos importantes
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To demonstrate (short-term objective) that fluid bolus and dobutamine infusion as compared to fluid bolus and placebo infusion increases the proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status with the dobutamine infusion alone in the first 72 hours from birth.
    • To demonstrate (medium-term objective) that fluid bolus and dobutamine infusion as compared to fluid bolus and placebo infusion increases the proportion of neonates alive without severe neurological complications at 36±2 weeks PMA.
    • Demostrar (objetivo a corto plazo) que la infusión de bolo fluido y dobutamina en comparación con la infusión de bolo fluido y placebo aumenta la proporción de recién nacidos que logran y mantienen un estado hemodinámico clínicamente aceptable con la infusión de dobutamina sola en las primeras 72 horas desde el nacimiento.
    • Demostrar (objetivo a medio plazo) que la infusión de bolo fluido y dobutamina en comparación con la infusión de bolo fluido y placebo aumenta la proporción de neonatos vivos sin complicaciones neurológicas graves a las 36 ± 2 semanas de edad Post Menstrual.
    E.2.2Secondary objectives of the trial
    • Short term (pharmacodynamic) endpoint: proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status with the dobutamine infusion alone in the first 72 hours from birth.
    • Medium term (clinical) endpoint: Proportion of neonates surviving without severe neurological complications at 36±2 weeks PMA.
    • Punto final a corto plazo (farmacodinámico): proporción de recién nacidos que logran y mantienen un estado hemodinámico clínicamente aceptable con la infusión de dobutamina sola en las primeras 72 horas desde el nacimiento.
    • Punto final a medio plazo (clínico): proporción de neonatos que sobreviven sin complicaciones neurológicas graves a las 36 ± 2 semanas de Edad Post Menstrual.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 24(+0) to 32(+6) weeks gestation
    • Admitted in the neonatal intensive care unit
    • Presence of haemodynamic insufficiency, defined as the presence of one or more of the following within first 72 hours after birth:
    o MABP < GA-1 (two readings, 15min apart) OR
    o Lactate > 4 mm/l OR
    o SVC flow <51 ml/kg/min
    • Provision of signed and dated informed consent form by patient’s parent/mother or legally designated representative.
    • 24 (+0) a 32 (+6) semanas de gestación
    • Admitido en la unidad de cuidados intensivos neonatales.
    • Presencia de insuficiencia hemodinámica, definida como la presencia de uno o más de los siguientes síntomas dentro de las primeras 72 horas después del nacimiento:
    o Presión arterial media <Edad Gestacional-1 (dos lecturas, 15 minutos de diferencia) O
    o Lactato> 4 mm / l O
    o flujo de VCS <51 ml / kg / min
    • Suministro de un formulario de consentimiento informado firmado y fechado por el padre / madre del paciente o un representante legalmente designado.
    E.4Principal exclusion criteria
    • Neonates considered non-viable, with a clinical decision not to provide life support
    • Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment
    • Infants already on commercial dobutamine treatment
    • Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects).
    • Infants in whom a surgical treatment is planned within 72 hours of birth
    • Infants carrying chromosomal anomalies
    • Lack of parental signed informed consent
    • Neonatos considerados no viables, con una decisión clínica de no proporcionar soporte vital
    • Bebés con hidropesía fetal congénita severa que necesitan drenaje torácico o peritoneal antes del reclutamiento
    • Bebés que ya están en tratamiento comercial con dobutamina.
    • Bebés con malformaciones congénitas que pueden afectar la adaptación cardiovascular (incluidos: hernia diafragmática congénita, gastrosquisis o defectos cardíacos congénitos).
    • Bebés en quienes se planifica un tratamiento quirúrgico dentro de las 72 horas posteriores al nacimiento.
    • Bebés portadores de anomalías cromosómicas.
    • Falta de consentimiento informado firmado por los padres
    E.5 End points
    E.5.1Primary end point(s)
    • Short term (pharmacodynamic) endpoint: proportion of neonates achieving and maintaining a clinically acceptable haemodynamic status with the dobutamine infusion alone in the first 72 hours from birth.
    • Medium term (clinical) endpoint: Proportion of neonates surviving without severe neurological complications at 36±2 weeks PMA.
    • Punto final a corto plazo (farmacodinámico): proporción de recién nacidos que logran y mantienen un estado hemodinámico clínicamente aceptable con la infusión de dobutamina sola en las primeras 72 horas desde el nacimiento.
    • Punto final a medio plazo (clínico): proporción de neonatos que sobreviven sin complicaciones neurológicas graves a las 36 ± 2 semanas de Edad Post Menstrual.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 36±2 weeks PMA.
    A las 36 ± 2 semanas de Edad Post Menstrual.
    E.5.2Secondary end point(s)
    • Absolute and relative frequencies of AEs and SAEs, to be recorded and compared between groups.
    • Optimal Starting Dose: Defined as the starting dose that provides the minimum number of dose steps until the efficient dose.
    • Frecuencias absolutas y relativas de acontecimiento Adverso y Acontecimiento Adverso Grave, para ser registradas y comparadas entre grupos.
    • Dosis inicial óptima: definida como la dosis inicial que proporciona el número mínimo de pasos de dosis hasta la dosis eficiente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout the study
    Durante el estudio
    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 Yes
    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) 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.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 No
    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
    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 months6
    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 months6
    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: 270
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 270
    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) 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 No
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 252
    F.4.2.2In the whole clinical trial 270
    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)
    None
    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 Decision2020-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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