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    Summary
    EudraCT Number:2021-003770-30
    Sponsor's Protocol Code Number:49RC21_0248
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-003770-30
    A.3Full title of the trial
    L’érythropoïétine pour améliorer le devenir des patients de soins intensifs – EPO-ICU-FS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    L’érythropoïétine pour améliorer le devenir des patients de soins intensifs – EPO-ICU-FS
    A.3.2Name or abbreviated title of the trial where available
    EPO-ICU-FS
    A.4.1Sponsor's protocol code number49RC21_0248
    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 SponsorCHU Angers
    B.1.3.4CountryFrance
    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 supportCHU Angers
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Angers
    B.5.2Functional name of contact pointJustine GONSARD
    B.5.3 Address:
    B.5.3.1Street Address4 Rue Larrey
    B.5.3.2Town/ cityANGERS
    B.5.3.3Post code49933
    B.5.3.4CountryFrance
    B.5.4Telephone number0241356329
    B.5.5Fax number0241355968
    B.5.6E-mailjustine.gonsard@chu-angers.fr
    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 EPOETINE ALFA
    D.2.1.1.2Name of the Marketing Authorisation holderEPREX
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameEPOIETINE ALFA
    D.3.2Product code B03XA01
    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.3.11 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) Yes
    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 placeboSolution for injection
    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
    Patients anémiques hospitalisés en réanimation
    E.1.1.1Medical condition in easily understood language
    Patients anémiques hospitalisés en réanimation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002272
    E.1.2Term Anemia
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10022519
    E.1.2Term Intensive care
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Etudier la faisabilité d’une étude clinique randomisée, contrôlée évaluant l’intérêt de l’EPO pour améliorer le devenir des patients adultes, anémiques, admis en soins intensifs
    E.2.2Secondary objectives of the trial
    Comparaison des deux bras de l’étude sont également prévus afin d’estimer l’effet de l’injection sous-cutanée d’érythropoïétine versus placebo pour des patients de soins intensifs en termes de :
    - évolution temporelle de l’hémoglobinémie,
    - valeur moyenne d’hémoglobine à J28 (ou sortie de l’hôpital) post-inclusion,
    - mortalités en soins intensifs et à l’hôpital (censurée à 90 jours de l’inclusion),
    - durées de séjour en soins intensifs et à l’hôpital (censurée à 90 jours de l’inclusion),
    - proportion de patients ayant reçu au moins une transfusion de culot globulaire à 90 jours de l’inclusion,
    - nombre de culots globulaires transfusés à 90 jours de l’inclusion,
    - survie à 90 jours après l’inclusion,
    - survenue d’une réadmission hospitalière (censurée à 90 jours après l’inclusion),
    - nombre de jours vivant à domicile à J90,
    - qualité de vie à 90 jours après l’inclusion ,
    - proportion de patients avec un évènement thromboembolique à J90 après l’inclusion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients adultes (âge > 18 ans),
    - admis en soins intensifs depuis plus de 72 heures et moins de 7 jours,
    - ayant reçu un soutien ventilatoire invasif et/ou un traitement avec un agent vasoactif pendant au moins un jour depuis l’admission,
    - ayant un taux d'Hb < 12 g/dl,
    - avec un consentement du patient ou d'un proche du patient (ou procédure d’inclusion en urgence)
    E.4Principal exclusion criteria
    Patient moribond,
    - Hospitalisation actuelle pour syndrome coronaire aigu,
    - Antécédents récents d'événement thromboembolique (< 3 mois),
    - Hypertension artérielle non contrôlée malgré un traitement antihypertenseur adéquat,
    - Myélodysplasie ou pathologie chronique nécessitant des transfusions itératives,
    - Traitement par l'EPO au cours des 30 derniers jours,
    - Participation à un autre essai interventionnel sur un agent stimulant l'érythropoïèse ou un traitement de l'anémie,
    - Sortie de l'unité de soins intensifs prévue dans les 24 heures,
    - Hypersensibilité connue à l'EPO ou à l'un de ses composants,
    - Antécédent d’érythroblastopénie suite à un traitement par érythropoétine
    - Femme enceinte, allaitante ou parturiente
    - Personne privée de liberté par décision judiciaire ou administrative
    - Personne faisant l’objet de soins psychiatriques sous la contrainte
    - Personne faisant l’objet d’une mesure de protection légale
    E.5 End points
    E.5.1Primary end point(s)
    L’objectif principal de cette étude est d’étudier la faisabilité d’une étude clinique randomisée, contrôlée évaluant l’intérêt de l’EPO pour améliorer le devenir des patients adultes, anémiques, admis en soins intensifs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    L’objectif principal sera évalué sur trois critères objectifs de faisabilité : le taux de recrutement, le respect des groupes d’attribution et la réalisation du suivi des patients inclus, en utilisant une approche en feux tricolore (vert-orange-rouge) incorporant les hypothèses de validation des critères de faisabilité.
    E.5.2Secondary end point(s)
    Les critères de jugement secondaires sont :
    - la proportion de patients perdus de vue à chaque visite,
    - le taux de données manquantes pour chaque critère de jugement (cf. objectifs exploratoires),
    - le taux de respect du protocole thérapeutique à chaque visite pour les patients hospitalisés,
    - la description des déviations au protocole en lien avec la faisabilité de l’étude
    E.5.2.1Timepoint(s) of evaluation of this end point
    Des objectifs exploratoires portant sur la comparaison des deux bras de l’étude sont prévus afin d’estimer l’effet de l’injection sous-cutanée d’EPO versus placebo pour des patients de soins intensifs en termes de :
    -évolution temporelle de l’hémoglobinémie
    -mortalités en soins intensifs et à l’hôpital
    -durées de séjour en soins intensifs et à l’hôpital
    -proportion de patients ayant reçu au moins une transfusion de culot globulaire à J90,
    -nombre de culots globulaires transfusés à J90
    -valeur moyenne d’hémoglobine à J28
    -survie à J90
    -nombre de jours vivant à domicile à J90
    -survenue d’une réadmission hospitalière
    -nombre de jours vivant à domicile (ou lieu de vie antérieur) à J90
    -qualité de vie à J90
    -proportion de patients avec un évènement thromboembolique à J90
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned3
    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
    the last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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 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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients hospitalisés en réanimation
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    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 Decision2021-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
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