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    Summary
    EudraCT Number:2017-001903-60
    Sponsor's Protocol Code Number:EFC14643
    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:2018-06-21
    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 number2017-001903-60
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents with Heterozygous Familial Hypercholesterolemia
    Estudio aleatorizado, doble ciego, controlado con placebo, seguido de un periodo de tratamiento abierto para evaluar la eficacia y la seguridad de alirocumab en niños y adolescentes con hipercolesterolemia familiar heterocigótica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Alirocumab in Children and Adolescents with Heterozygous Familial Hypercholesterolemia
    Estudio para evaluar la eficacia y la seguridad de alirocumab en niños y adolescentes con hipercolesterolemia familiar heterocigótica
    A.4.1Sponsor's protocol code numberEFC14643
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1193-0721
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/269/2017
    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 & 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 pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 namealirocumab
    D.3.2Product code SAR236553
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNalirocumab
    D.3.9.1CAS number 1245916-14-6
    D.3.9.2Current sponsor codeSAR236553 (RGN727)
    D.3.9.4EV Substance CodeSUB170596
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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.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 namealirocumab
    D.3.2Product code SAR236553
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNalirocumab
    D.3.9.1CAS number 1245916-14-6
    D.3.9.2Current sponsor codeSAR236553 (RGN727)
    D.3.9.4EV Substance CodeSUB170596
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypercholesterolaemia
    Hipercolesterolemia
    E.1.1.1Medical condition in easily understood language
    Hypercholesterolaemia
    Hipercolesterolemia
    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 PT
    E.1.2Classification code 10020603
    E.1.2Term Hypercholesterolaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in patients with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal
    stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of nonstatin LMTs in case of intolerance to statins.
    Evaluar la eficacia de alirocumab administrado cada 2 semanas (C2S) frente a placebo después de 24 semanas de tratamiento con doble enmascaramiento (DE) sobre las concentraciones de colesterol transportado por lipoproteínas de baja densidad (C-LDL) en pacientes con hipercolesterolemia familiar heterocigótica (HFhe) de 8 a 17 años de edad tratados con una dosis óptima estable diaria de estatinas ± otros tratamientos modificadores de los lípidos (TML) o con una dosis estable de TML no estatínico en caso de intolerancia a las estatinas.
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of alirocumab versus placebo on low-density lipoprotein cholesterol (LDL-C) levels.
    -To evaluate the effects of alirocumab versus placebo on other lipid parameters.
    -To evaluate the safety and tolerability of alirocumab in comparison with placebo.
    -To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment.
    -To evaluate the development of anti-alirocumab antibodies.
    - Evaluar la eficacia de alirocumab frente a placebo sobre las concentraciones de C-LDL después de 12 semanas de tratamiento con DE.
    - Evaluar los efectos de alirocumab frente a placebo sobre otros parámetros lipídicos
    - Evaluar la seguridad y la tolerabilidad de alirocumab después de 24 semanas de tratamiento en comparación con placebo.
    - Evaluar la eficacia, la seguridad y la tolerabilidad de alirocumab después de 80 semanas de tratamiento en abierto.
    - Evaluar el desarrollo de anticuerpos antialirocumab después de 24 semanas de tratamiento durante el periodo de tratamiento con doble enmascaramiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A non-invasive flow mediated dilatation assessment will be part of a substudy (n=30 to 39) performed at selected sites.
    Subestudio de dilatación mediada por el flujo (DMF), (n = 30 a 39) realizado en centros seleccionados.
    E.3Principal inclusion criteria
    -Children and adolescent male and female patients aged 8 to 17 years at the time of signed informed consent.
    -Patients with diagnosis of heterozygous familial hypercholesterolemia (heFH) through genotyping or clinical criteria.
    -Patients treated with optimal dose of statin +/- other LMT(s) or non-statin LMT(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling.
    -Patients with calculated LDL-C greater than or equal to 130 mg/dL (≥3.37 mmol/L) at the screening visit except for patients who have previously participated in the DFI14223 study.
    -A signed informed consent indicating parental permission with or without patient assent.
    - Niños y adolescentes de ambos sexos de edades de entre 8 y 17 años en el momento del consentimiento informado firmado.
    - Pacientes con diagnóstico de hipercolesterolemia familiar heterocigota (HFhe) a través del genotipo o criterios clínicos.
    - Pacientes tratados con dosis óptimas de estatinas +/- otros TML (s) o TML (s) sin estatina (s) si no toleran estatinas a dosis estables durante al menos 4 semanas antes de la analítica de selección de los lípidos.
    - Pacientes con LDL-C calculado mayor o igual a 130 mg / dL (≥3.37 mmol / L) en la visita de selección, excepto para los pacientes que participaron previamente en el estudio DFI14223.
    -Un consentimiento informado firmado que indica el permiso de los padres con o sin asentimiento del paciente.
    E.4Principal exclusion criteria
    -Patient with body weight less than 25 kg.
    -Patients aged of 8 to 9 years not at Tanner stage 1 and patients aged of 10 to 17 years not at least at Tanner stage 2 in their development.
    -Patients with secondary hyperlipidemia.
    -Diagnosis of homozygous familial hypercholesterolemia.
    -Patient who has received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study.
    -Patients with uncontrolled type 1 or type 2 diabetes mellitus.
    -Patients with known uncontrolled thyroid disease.
    -Patients with uncontrolled hypertension.
    -Fasting triglycerides >350 mg/dL (3.95 mmol/L).
    -Severe renal impairment (ie, estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m^2.
    -Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN).
    -Creatinine phosphokinase (CPK) >3 x ULN.
    -Paciente con un peso corporal inferior a 25 kg.
    - Los pacientes con edades comprendidas entre 8 y 9 años no en estadío 1 de Tanner y los pacientes con edades comprendidas entre 10 y 17 años, al menos en estadío 2 de Tanner en su desarrollo.
    - Pacientes con hiperlipidemia secundaria.
    -Diagnóstico de hipercolesterolemia familiar homocigótica.
    - Paciente que ha recibido tratamiento de aféresis lipídica dentro de los 2 meses previos al período de selección o tiene planes para recibirlo durante el estudio.
    - Pacientes con diabetes mellitus tipo 1 o tipo 2 no controlada.
    - Pacientes con enfermedad tiroidea descontrolada conocida.
    - Pacientes con hipertensión no controlada.
    -Triglicéridos en ayunas >350 mg/dl (3,95 mmol/l) en la visita de selección.
    - Insuficiencia renal grave (es decir, tasa de filtración glomerular estimada [TFGe] <30 ml / min / 1,73 m2
    -Alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST)> 2 x límite superior de la normalidad (LSN).
    -Creatinina fosfokinasa (CPK)> 3 x ULN.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in low-density lipoprotein cholesterol (LDL-C): Percent change in LDL-C from baseline to Week 24
    Cambio porcentual en el C-LDL desde el inicio hasta la Semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 24
    Desde el inicio hasta la Semana 24
    E.5.2Secondary end point(s)
    1) Percent change in LDL-C: Percent change in LDL-C
    2) Percent change in Apo B: Percent change in Apo B
    3) Percent change in non-high density lipoprotein cholesterol (non HDL-C): Percent change in non-HDL-C
    4) Percent change in Total-C: Percent change in Total-C
    5) Patients with LDL-C level <130 mg/dL (3.37 mmol/L): Proportion of patients with LDL-C level < 130 mg/dL (3.37 mmol/L) at Week 12 and at Week 24
    6) Patients with LDL-C level <110 mg/dL (2.84 mmol/L): Proportion of patients with LDL-C level < 110 mg/dL (2.84 mmol/L) at Week 12 and at Week 24
    7) Percent change in Lp(a): Percent change in lipoprotein (a) from baseline to Week 12 and to Week 24
    8) Percent change in HDL-C: Percent change in HDL-C from baseline to Week 12 and to Week 24
    9) Percent change in TG: Percent change in fasting triglycerides (TG) from baseline to Week 12 and to Week 24
    10) Percent change in Apo A-1: Percent change in apolipoprotein A1 (Apo A-1) from baseline to Week 12 and to Week 24
    11) Number of patients with adverse events: Number of patients with adverse events
    12) Cogstate battery test: The Cogstate battery test will assess maturing cognition across a broad number of key developmental functions
    13) Tanner stage: The Tanner stages will be measured to assess stages of pubertal development
    1) Cambio porcentual en LDL-C: cambio porcentual en LDL-C
    2) Cambio porcentual en Apo B: cambio porcentual en Apo B
    3) Cambio porcentual en el colesterol de lipoproteínas de alta densidad (no HDL-C): cambio porcentual en no HDL-C
    4) Cambio porcentual en Total-C: cambio porcentual en Total-C
    5) Pacientes con niveles de c-LDL <130 mg / dl (3,37 mmol / l): Proporción de pacientes con niveles de c-LDL <130 mg / dl (3,37 mmol / l) en la semana 12 y en la semana 24
    6) Pacientes con niveles de LDL-C <110 mg / dL (2,84 mmol / L): Proporción de pacientes con niveles de LDL-C <110 mg / dL (2,84 mmol / L) en la Semana 12 y en la Semana 24
    7) Cambio porcentual en Lp (a): cambio porcentual en la lipoproteína (a) desde el inicio hasta la semana 12 y hasta la semana 24
    8) Cambio porcentual en HDL-C: cambio porcentual en HDL-C desde el inicio hasta la semana 12 y hasta la semana 24
    9) Cambio porcentual en TG: cambio porcentual en los triglicéridos en ayunas (TG) desde el inicio hasta la semana 12 y hasta la semana 24
    10) Cambio porcentual en Apo A-1: ​​cambio porcentual en la apolipoproteína A1 (Apo A-1) desde el inicio hasta la semana 12 y hasta la semana 24
    11) Número de pacientes con acontecimientos adversos: Número de pacientes con acontecimientos adversos
    12) Batería de pruebas Cogstate: la batería de pruebas Cogstate evaluará la cognición de maduración en un amplio número de funciones clave de desarrollo
    13) Estadíos de Tanner: los estadíos de Tanner se medirán para evaluar las etapas del desarrollo puberal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) From baseline to Week 12
    2) to 10) From baseline to Week 12 and to Week 24
    11) Up to Week 104
    12) A Day 1, Weeks 24, 68, and 104
    13) At Weeks 24, 44, 68, and 104
    1) Desde el inicio hasta la semana 12
    2) a 10) Desde el inicio hasta la Semana 12 y hasta la Semana 24
    11) Hasta la semana 104
    12) A día 1, semanas 24, 68 y 104
    13) En las semanas 24, 44, 68 y 104
    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 Yes
    E.6.13.1Other scope of the trial description
    heFH genotyping
    Genotipado de hipercolesterolemia familiar heterocigótica (HFhe)
    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) 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.8.2.4Number of treatment arms in the trial2
    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 EEA26
    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
    Argentina
    Austria
    Brazil
    Bulgaria
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Lebanon
    Mexico
    Netherlands
    Norway
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    Taiwan
    Turkey
    United States
    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 years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 500
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 250
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 250
    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
    Children and adolescents from 8 to 17 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 500
    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
    Ninguno
    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 Decision2018-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-30
    P. End of Trial
    P.End of Trial StatusOngoing
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