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    Summary
    EudraCT Number:2016-002983-16
    Sponsor's Protocol Code Number:EVOLAFER01
    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:2016-11-18
    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 number2016-002983-16
    A.3Full title of the trial
    PILOT STUDY TO COMPARE THE EFFICACY OF EVOLOCUMAB VS LDL-APHERESIS IN PATIENTS WITH HYPERCHOLESTEROLEMIA
    ESTUDIO PILOTO COMPARATIVO DE LA EFICACIA DE EVOLOCUMAB VERSUS LDL-AFERESIS EN PACIENTES CON HIPERCOLESTEROLEMIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TREATMENT OF HYPERCHOLESTEROLEMIA WITH EVOLOCUMAB
    TRATAMIENTO DE HIPERCOLESTEROLEMIA CON EVOLOCUMAB
    A.3.2Name or abbreviated title of the trial where available
    TRATAMIENTO CON EVOLOCUMAB
    A.4.1Sponsor's protocol code numberEVOLAFER01
    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 DE NEFROLOGIA
    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 supportHospital General Universitario Gregorio Marañon
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital General Universitario Gregorio Marañon
    B.5.2Functional name of contact pointServicio de Nefrologia
    B.5.3 Address:
    B.5.3.1Street AddressDOCTOR ESQUERDO 46
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number915868319
    B.5.5Fax number915868386
    B.5.6E-mailmarian.goicoechea@gmail.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 Yes
    D.2.1.1.1Trade name EVOLOCUMAB
    D.2.1.1.2Name of the Marketing Authorisation holderREPATHA
    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.3.1Product nameEVOLOCUMAB
    D.3.2Product code EMEA/H/C/003766
    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 INNEVOLOCUMAB
    D.3.9.1CAS number 1256937-27-5
    D.3.9.4EV Substance CodeSUB128552
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    FAMILIAR HYPERCHOLESTEROLEMIA
    TRATAMIENTO CON EVOLOCUMAB
    E.1.1.1Medical condition in easily understood language
    FAMILIAR HYPERCHOLESTEROLEMIA
    HIPERCOLESTEROLEMIA FAMILIAR
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 COMPARE THE EFFICACY AND SECURITY OF EVOLOCUMAB TREATMENT VS LDL-APHERESIS IN PATIENTS WITH FAMILIAR HYPERCHOLESTEROLEMIA AND HIGH RISK CARDIOVASCULAR
    TO EVALUATE THE COMBINATION OF LDL-APHERESIS WITH EVOLOCUMAB IN THE FAMILIAR HYPERCHOLESTEROLEMIA TREATMENT
    a) Comparar la eficacia y seguridad del tratamiento con evolocumab versus LDL-aferesis en pacientes con hipercolesterolemia familiar y alto riesgo cardiovascular
    b) Evaluar la combinación de LDL-aferesis y evolocumab con el objetivo de optimizar los recursos en el tratamiento de pacientes con hipercolesterolemia familiar
    E.2.2Secondary objectives of the trial
    TO COMPARE THE ANTIINFLAMMATORY AND IMMUNOLOGIC EFFECT OF LDL-APHERESIS VS EVOLOCUMAB
    Comparar el efecto antiinflamatorio y sobre el sistema inmunológico de LDL-aferesis vs evolocumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PATIENTS OLDER THAN 18
    FAMILIAR HYPERCHOLESTEROLEMIA WITH LDL-CHOLESTEROL GREATER THAN 100 MG/DL AND TREATMENT WITH HIGHER STATIN DOSAGE, AND PREVIOUS CARDIOVASCULAR EVENTS
    PATIENTS WITH LDL-APHERESIS TREATMENT
    -pacientes con edad >18 años
    -hipercolesterolemia con LDL-colesterol>100 mg/dl en tratamiento con la dosis máxima tolerada de estatinas y antecedentes de enfermedad cardiovascular severa
    -pacientes que están incluidos en programa de LDL-aferesis/quincenalmente
    E.4Principal exclusion criteria
    EVOLOCUMAB CONTRAINDICATIONS
    HOSPITALIZATION IN THREE PREVIOUS MONTHS
    CARDIOVASCULAR EVENTS IN THREE PREVIOUS MONTHS
    - contraindicaciones para recibir evolocumab según ficha técnica.
    -ingreso hospitalario de cualquier causa en los tres últimos meses previos a la inclusión del estudio
    -evento cardiovascular en los tres meses previos a la inclusión del estudio
    -Incapacidad para la firma del consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    DECREASE OF LDL-CHOLESTEROL LEVELS IN PATIENTS IN TREATMENT WITH LDL-APHERESIS VS EVOLOCUMAB VS COMBINATION OF LDL-APHERESIS AND EVOLOCUMAB
    Variable principal del estudio: descenso de niveles de LDL-colesterol en los tres grupos de estudio: LDL-aferesis, evolocumab y combinación LDL-aferesis y evolocumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 MONTHS
    6 MESES
    E.5.2Secondary end point(s)
    CHANGES OF APOB, APOA, HDL-CHOLESTEROL, TRIGLICERIDES AND LP(a)
    CHANGE OF INFLAMMATORY PARAMETERS
    CHANGE OF IMMUNOLOGIC PARAMETERS
    Variables secundarias :
    -modificación de otros parámetros lipídicos: apoB, apo A, HDL-colesterol, triglicéridos y lipoproteína A
    -efecto antiinflamatorio: fibrinógeno, ferritina, proteína C reactiva
    -efecto sobre inmunidad: inmunoglobulinas y complemento sérico.
    -cualquier reacción adversa
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 MONTHS
    6 MESES
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    SAE
    INFORM CONSENT WITHDRAW
    CARDIOVASCULAR EVENT
    EFECTO ADVERSO GRAVE
    RETIRADA DEL CONSENTIMIENTO INFORMADO
    CUALQUIER EVENTO CARDIOVASCULAR
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 10
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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 Decision2017-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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