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    The EU Clinical Trials Register currently displays   35503   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2017-004521-32
    Sponsor's Protocol Code Number:D5780C00007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-02
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-004521-32
    A.3Full title of the trial
    A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
    Estudio de fase IIb, randomizado, controlado con placebo para evaluar la seguridad y la eficacia de MEDI6012 en el infarto de miocardio agudo con elevación del segmento ST
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
    Estudio de fase IIb, randomizado, controlado con placebo para evaluar la seguridad y la eficacia de MEDI6012 en el infarto de miocardio agudo con elevación del segmento ST
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD5780C00007
    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 SponsorMedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC
    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 supportMedImmune LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.4Telephone number+4672 589 5813
    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 nameMEDI6012
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEDI6012
    D.3.9.2Current sponsor codeMEDI6012
    D.3.9.3Other descriptive namerecombinant human lecithin-cholesterol acyltransferase (rhLCAT)
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    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 infusion
    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
    ST-elevation myocardial infarction
    Infarto de miocardio con elevación del segmento ST
    E.1.1.1Medical condition in easily understood language
    Heart attack
    Ataque cardíco
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064345
    E.1.2Term ST segment elevation myocardial infarction
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of MEDI6012 on infarct size compared with placebo.
    Evaluar el efecto de MEDI6012 en el tamaño del infarto en comparación con placebo.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of MEDI6012 on LV systolic function compared to placebo.
    2. To evaluate the effect of MEDI6012 on non-calcified coronary plaque regression/progression from baseline to 10-12 weeks compared with placebo.
    3. To evaluate the effect of MEDI6012 on remodeling of the LV measured by myocardial mass and volumes.
    4. To evaluate the safety and tolerability of MEDI6012.
    5. To describe the pharmacokinetics (PK) and immunogenicity of MEDI6012.
    1. Evaluar el efecto de MEDI6012 en la función sistólica VI en comparación con placebo.
    2. Evaluar el efecto de MEDI6012 en la regresión/progresión de la placa ateromatosa coronaria no calcificada desde el periodo basal hasta las 10-12 semanas en comparación con placebo.
    3. Evaluar el efecto de MEDI6012 en la remodelación del VI determinada mediante la masa miocárdica y los volúmenes.
    4. Evaluar la seguridad y la tolerabilidad de MEDI6012.
    5. Describir las propiedades farmacocinéticas (FC) y la inmunogenicidad de MEDI6012.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women without child-bearing potential aged 30-80 years of age who are capable and willing to provide informed consent.
    2. Acute STEMI diagnosed by ST elevation (≥ 0.1 mV) in 2 contiguous leads
    3. Planned for primary PCI
    4. Ischemic symptoms for ≤ 6 hours
    5. Capable of completing study visits
    1. Varones y mujeres que no tengan capacidad de procrear (para las definiciones, consúltese el apartado 10.2) y de 30 a 80 años que estén dispuestos a proporcionar un consentimiento informado y sean capaces de hacerlo.
    2. IMEST agudo diagnosticado por la elevación del segmento ST (≥ 0,1 mV) en 2 electrodos contiguos.
    3. Sujetos en los que está previsto realizar una ICP primaria.
    4. Síntomas isquémicos de ≤ 6 horas de evolución.
    5. Capaces de completar las visitas del estudio
    E.4Principal exclusion criteria
    1. Pre-randomization cardiogenic shock or cardiopulmonary resuscitation
    2. Fibrinolytic administration for index event
    3. Known prior MI or prior coronary artery bypass grafting
    4. Known pre-existing cardiomyopathy
    5. History of anaphylaxis
    6. Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)
    7. Other condition or severe illness that the investigator feels would limit the prognosis of the patient (eg, malignancy with life-expectancy < 3 months) or would make the patient otherwise unsuitable for enrollment (eg, pose a hazard or undue burden to the patient [known chronic renal or hepatic impairment, recent (< 30 days), cerebrovascular accident or transient ischemic attack] unable to complete study visits)
    8. Known contraindication to MR imaging (eg, metallic implant, claustrophobia, implantable cardioverter-defibrillator (ICD), pacemaker, known eGFR<30 mL/min/1.73m2)
    9. Pregnant women
    1. Choque cardiógeno o reanimación cardiopulmonar antes de la randomización.
    2. Administración de fibrinolíticos para tratar el episodio inicial.
    3.Antecedentes conocidos de IM o injerto de derivación coronaria.
    4. Miocardiopatía preexistente conocida.
    5. Antecedentes de anafilaxia.
    6. Posible causa no trombótica (es decir, vasoespasmo, disección, miocardiopatía de Takotsubo)
    7. Otra afección o enfermedad grave que, en opinión del investigador, limitaría el pronóstico del paciente (p. ej., neoplasia maligna con una esperanza de vida < 3 meses) o haría que el paciente, por cualquier otro motivo, no fuera apto para su inclusión (p. ej., supondría un riesgo o una carga excesiva para el paciente [disfunción renal o hepática crónica conocida, accidente cerebrovascular o accidente isquémico transitorio reciente (< 30 días)], incapaz de completar las visitas del estudio).
    8. Contraindicación conocida a la RM (p. ej., implante metálico, claustrofobia, desfibrilador cardioversor implantable (DCI), marcapasos, FGe conocida < 30 ml/min/1,73 m2).
    9. Mujeres embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    Infarct size as a percentage of LV mass measured on delayed-enhanced (CV magnetic resonance [CMR]) imaging 10-12 weeks post-MI compared to placebo.
    Tamaño del infarto expresado como porcentaje de la masa VI medida mediante imágenes con contraste tardías de resonancia magnética CV (RMC) a las 10-12 semanas después del IM, en comparación con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10-12 weeks post myocardial infarction
    10-12 semanas después del Infarto de miocardio
    E.5.2Secondary end point(s)
    • EF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI compared to placebo.
    • Change in NCPV in the coronary arteries from index computed tomography angiography (CTA) to 10-12 weeks post-MI compared with placebo.
    • Myocardial mass and LV volumes at end-systole and end-diastole.
    • Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).
    • Lecithin-cholesterol acyltransferase (LCAT) mass and anti-drug antibodies (ADAs).
    • FE determinada mediante cine-resonancia magnética (cine-RM) a las 10-12 semanas tras el IM, en comparación con placebo.
    • Variación del VPNC en las arterias coronarias desde la angiotomografía computarizada (ATC) inicial hasta 10-12 semanas después del infarto, en comparación con placebo.
    • Masa del miocardio y volúmenes sistólico final y diastólico final del VI.
    • Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAT) y de acontecimientos adversos graves (AAG) surgidos durante el tratamiento (AAGT).
    •Concentración de lecitina-colesterol aciltransferasa (LCAT) y anticuerpos antifármaco (AAF).
    E.5.2.1Timepoint(s) of evaluation of this end point
    10-12 weeks post myocardial infarction
    10-12 semanas después del Infarto de miocardio
    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 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. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    paciente/MedImmune ciegos, investigador no ciego
    subject/MedImmune blinded, investigator unblinded
    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 trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Czech Republic
    Russian Federation
    United Kingdom
    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
    The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) or death for the last subject in the study.
    El final del estudio se define como la fecha de la última visita/procedimiento especificado por el protocolo (incluyendo el contacto telefónico) o la muerte del último paciente en el estudio
    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 days
    E.8.9.2In all countries concerned by the trial years3
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 114
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 322
    F.4.2.2In the whole clinical trial 414
    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)
    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 Decision2018-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-26
    P. End of Trial
    P.End of Trial StatusOngoing
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