{"ctNumber":"2024-516402-32-00","ctStatus":"Authorised","startDateEU":"2024-02-13","decisionDate":"2024-11-12T10:08:36.301","publishDate":"2026-03-10T02:48:49.848259184","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":119137,"rowSubjectCount":0,"products":[{"id":493939,"part1MpRoleTypeCode":"2","productDictionaryInfo":{"productPharmForm":"PHF00016MIG","euMpNumber":"SCP77771137","marketingAuthNumber":"-","prodAuthStatus":2,"activeSubstanceName":"ECULIZUMAB","euSubstNumber":"SUB25187","productSubstances":[{"substancePk":"425945","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"ECULIZUMAB","substanceEvCode":"SUB25187","synonyms":["ABP-959","H5G1.1"]}],"atcCode":"L04AA25","atcName":"ECULIZUMAB\r","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":true,"orphanDrugDesigNumber":"EU/3/13/1185","doseUom":"mg 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associated with HE and severe kidney involvement (needing dialysis or serum creatinine ≥ 354μM)","medicalConditionTranslations":[{"id":9799870,"uuid":"fdad1c42-59c3-4af5-a68a-30fcbe7f76f2","attributeTranslation":"Patients adultes présentant un SHUA associé à une HE et une atteinte rénale sévère (nécessitant une dialyse ou taux de créatinine sérique ≥  354µM)","language":10,"languageDescription":"French"}],"isConditionRareDisease":false}],"meddraConditionTerms":[{"termId":200000003022,"version":"20.1","level":"PT","termName":"Atypical haemolytic uraemic syndrome","classificationCode":"10079840","organClass":100000004851,"active":false}]},"trialObjective":{"trialScopes":[{"code":"5","trialScopeId":360674},{"code":"3","trialScopeId":360672},{"code":"4","trialScopeId":360673}],"mainObjective":"To demonstrate the efficacy of early Eculizumab administration added on standard of care BP control on dialysis-dependence at month 6 in HEaHUS patients with severely impaired initial renal function.","mainObjectiveTranslations":[{"id":9799904,"uuid":"108ad23b-87e5-4282-85ed-65111a60cc6c","attributeTranslation":"Démontrer l'efficacité de l'administration précoce d'Eculizumab, ajoutée au contrôle standard de la pression artérielle, sur la dépendance à la dialyse au troisième mois chez les patients atteints d’SHUa-HE dont la fonction rénale initiale est sévèrement altérée.","language":10,"languageDescription":"French"}],"secondaryObjectives":[{"id":419230,"number":1,"secondaryObjective":"To evaluate the role of complement biomarkers in predicting therapeutic response","secondaryObjectiveTranslations":[{"id":9799906,"uuid":"07268606-c4f0-46a9-8867-97db74eebb4b","attributeTranslation":"Évaluer le rôle des biomarqueurs du complément dans la prédiction de la réponse thérapeutique","language":10,"languageDescription":"French"}]},{"id":419231,"number":2,"secondaryObjective":"To evaluate the frequency of complement genetic rare variants in this population","secondaryObjectiveTranslations":[{"id":9799907,"uuid":"bbe6a143-df26-4bbb-b8de-be00c89e3e16","attributeTranslation":"Évaluer la fréquence des variants génétiques rares du complément dans cette population","language":10,"languageDescription":"French"}]},{"id":419232,"number":3,"secondaryObjective":"To evaluate the efficacy of early eculizumab administration added on standard of care BP control on 3-month (W13) and 12 months renal replacement therapy risk","secondaryObjectiveTranslations":[{"id":9799908,"uuid":"87b68711-7ad4-45ec-872f-2699fe40e829","attributeTranslation":"Évaluer l'efficacité de l'administration précoce d'éculizumab, ajoutée au contrôle de la pression artérielle standard, sur le risque de traitement de suppléance rénale à 3 mois et 12 mois","language":10,"languageDescription":"French"}]},{"id":419233,"number":4,"secondaryObjective":"To evaluate the frequency of severe infections in both groups","secondaryObjectiveTranslations":[{"id":9799909,"uuid":"d30a20fc-f866-4532-813a-e56be92d6145","attributeTranslation":"Évaluer la fréquence des infections graves dans les deux groupes","language":10,"languageDescription":"French"}]},{"id":419234,"number":5,"secondaryObjective":"To evaluate the time to resolution of hemolysis and acute dialysis","secondaryObjectiveTranslations":[{"id":9799910,"uuid":"415cebe1-a77b-4c0a-bb4c-010ca47a0405","attributeTranslation":"Évaluer le temps de résolution de l'hémolyse et de la dialyse aiguë","language":10,"languageDescription":"French"}]},{"id":419235,"number":6,"secondaryObjective":"To evaluate the frequency of histological lesions and their prognosis (if kidney biopsy is performed)","secondaryObjectiveTranslations":[{"id":9799911,"uuid":"4ddffd03-28b4-4360-a6fa-f954d6cfa04c","attributeTranslation":"Évaluer la fréquence des lésions histologiques et leur pronostic (si une biopsie rénale est réalisée)","language":10,"languageDescription":"French"}]},{"id":419236,"number":7,"secondaryObjective":"To evaluate the medico-economic impact of Eculizumab","secondaryObjectiveTranslations":[{"id":9799912,"uuid":"dff80df0-b20e-4c2c-b219-1ebaa575eb5c","attributeTranslation":"Évaluer l'impact médico-économique de l'éculizumab","language":10,"languageDescription":"French"}]},{"id":419237,"number":8,"secondaryObjective":"Objective of the first ancillary study: A first ancillary study will include a pangenomic analysis aimed at identifying new genetic variants associated with HE-aHUS. This ancillary study will be based on the residual genetic samples already scheduled in the biocollection. This ancillary study will be coordinated by Pr L. Mesnard (Nephrology Department, Tenon Hospital, Paris) and performed according to an already available funding","secondaryObjectiveTranslations":[{"id":9799913,"uuid":"9b62ccd2-27dc-4033-acbf-ecea1a7946b7","attributeTranslation":"Objectif de la première étude ancillaire :\nUne première étude ancillaire comprendra une analyse pangénomique visant à identifier de nouveaux variants génétiques associés au HE-aHUS. Cette étude ancillaire sera basée sur les échantillons génétiques résiduels déjà prévus dans la biocollection. Cette étude ancillaire sera coordonnée par le Pr L. Mesnard (Service de Néphrologie, Hôpital Tenon, Paris) et réalisée selon un financement déjà disponible.","language":10,"languageDescription":"French"}]},{"id":419238,"number":9,"secondaryObjective":"Objective of any other potential ancillary study: biological collection For any other ancillary study: residual samples will be stored for a biological collection to identify new potential genetic and pathophysiological determinants of HE-aHUS (Department of Immunobiology, HEGP, Dr Frémeaux-Bacchi).","secondaryObjectiveTranslations":[{"id":9799914,"uuid":"1a578a86-4a8c-46ef-9042-1f8659d6b433","attributeTranslation":"Objectif de toute(s) autre(s) étude(s) ancillaire(s) potentielle(s) : collection biologique \nIdentifier de nouveaux variants génétiques liés à l'HE-aHUS.\nPour toute autre étude ancillaire : les échantillons résiduels seront conservés pour une collection biologique afin d'identifier de nouveaux déterminants génétiques et physiopathologiques potentiels du HE-aHUS (Département 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posterior reversible encephalopathy syndrome), or cardiovascular involvement (notably acute left ventricular failure, acute pulmonary edema, acute cardiac ischemia, chest pain, dyspnea, palpitations), or ophtalmological involvement (notably ischemic retinopathy or blurred vision)","principalInclusionCriteriaTranslations":[{"id":9799900,"uuid":"7e6c135b-773e-4c48-a416-4e3f1455a2eb","attributeTranslation":"Hospitalisation pour un SHUa-HE dans les 10 jours précédents :\no Présomption d'insuffisance rénale aiguë (traitement de substitution rénale ou taux de créatinine sérique ≥  354µM \no Hémolyse mécanique comprenant : anémie, et: thrombopénie, ou haptoglobine basse (1,5UNL), ou présence de schisocytes ou lésions histologiques de microangiopathie thrombotique\no Hypertension sévère avec une pression artérielle systolique >180mmHg et/ou une pression artérielle diastolique>110mmHg\no Atteinte des organes cibles, y compris atteinte neurologique (notamment encéphalopathie hypertensive, céphalées, confusion, nausées, syndrome d'encéphalopathie réversible postérieure), ou atteinte cardiovasculaire (notamment insuffisance ventriculaire gauche aiguë, œdème pulmonaire aigu, ischémie cardiaque aiguë, douleurs thoraciques, dyspnée, palpitations), ou atteinte ophtalmologique (notamment rétinopathie ischémique ou vision trouble).","language":10,"languageDescription":"French"}]},{"id":801636,"number":3,"principalInclusionCriteria":"For women of childbearing potential: Effective contraception during the study and for at least 5 months after the last dose of treatment with eculizumab","principalInclusionCriteriaTranslations":[{"id":9799901,"uuid":"09ac03b5-524d-4d75-8819-863f66521a38","attributeTranslation":"Pour les femmes en mesure de procréer : Contraception efficace durant la recherche et au moins jusqu’à 5 mois après la dernière administration d’éculizumab","language":10,"languageDescription":"French"}]},{"id":801637,"number":4,"principalInclusionCriteria":"Subject affiliated to a social security regimen","principalInclusionCriteriaTranslations":[{"id":9799902,"uuid":"95a390e5-9f18-42c1-af8f-ae7abbdd080b","attributeTranslation":"Sujet affilié à un régime de sécurité sociale","language":10,"languageDescription":"French"}]},{"id":801638,"number":5,"principalInclusionCriteria":"Subject having signed written informed consent","principalInclusionCriteriaTranslations":[{"id":9799903,"uuid":"66d44e6e-849e-4516-9f1c-3f9c350bd6f2","attributeTranslation":"Sujet ayant signé un consentement éclairé écrit","language":10,"languageDescription":"French"}]}],"principalExclusionCriteria":[{"id":1373170,"number":1,"principalExclusionCriteria":"Atrophic kidneys with maximum length<8cm on recent (<1 month) renal ultrasound, CT scan, or renal MRI","principalExclusionCriteriaTranslations":[{"id":9799880,"uuid":"adcf01d1-7f68-403e-8258-5566c02e13cc","attributeTranslation":"Reins atrophiés dont la longueur maximale est inférieure à 8 cm sur une échographie rénale, une tomodensitométrie ou une IRM rénale récente (<1 mois)","language":10,"languageDescription":"French"}]},{"id":1373171,"number":10,"principalExclusionCriteria":"Contra-indication to eculizumab or renin angiotensin system blockers","principalExclusionCriteriaTranslations":[{"id":9799881,"uuid":"09ea1f67-0d8d-4bcc-a5f2-6e642c5e45ab","attributeTranslation":"Contre-indication à l'éculizumab ou aux bloqueurs du système rénine angiotensine.","language":10,"languageDescription":"French"}]},{"id":1373172,"number":11,"principalExclusionCriteria":"Solid organ or haematopoietic transplant","principalExclusionCriteriaTranslations":[{"id":9799882,"uuid":"14cab41d-3b9e-4aa8-8795-4112c60adf85","attributeTranslation":"Greffe d'organe solide ou hématopoïétique","language":10,"languageDescription":"French"}]},{"id":1373173,"number":12,"principalExclusionCriteria":"History (<1year) of active cancer or exposition to drugs associated with aHUS (< 3 months)","principalExclusionCriteriaTranslations":[{"id":9799883,"uuid":"270eda57-9fd2-4056-8450-c0b6ecab9c9b","attributeTranslation":"Antécédents (<1 an) de cancer actif ou d'exposition à des médicaments associés au SHUa (< 3 mois)","language":10,"languageDescription":"French"}]},{"id":1373174,"number":13,"principalExclusionCriteria":"Severe cognitive or psychiatric disorders, patients unable to give an informed consent","principalExclusionCriteriaTranslations":[{"id":9799884,"uuid":"d53dd363-d48f-49fe-9562-e3270dc3927e","attributeTranslation":"Troubles cognitifs ou psychiatriques graves, patients incapables de donner un consentement éclairé.","language":10,"languageDescription":"French"}]},{"id":1373175,"number":14,"principalExclusionCriteria":"Positive SARS-CoV2 PCR or antigenic test","principalExclusionCriteriaTranslations":[{"id":9799885,"uuid":"467bd043-4060-4ed0-bd2c-13c20c285b2d","attributeTranslation":"PCR SARS-CoV2 ou test antigénique positif","language":10,"languageDescription":"French"}]},{"id":1373176,"number":15,"principalExclusionCriteria":"Pregnant or breastfeeding woman or ineffective contraception","principalExclusionCriteriaTranslations":[{"id":9799886,"uuid":"be3e9250-bb44-4126-8eea-b6266c20d499","attributeTranslation":"Femme enceinte ou allaitante ou contraception inefficace","language":10,"languageDescription":"French"}]},{"id":1373177,"number":16,"principalExclusionCriteria":"Persons deprived of their liberty by judicial or administrative decision","principalExclusionCriteriaTranslations":[{"id":9799887,"uuid":"fd2c9b7a-62e3-4e09-a0fe-5da355c75438","attributeTranslation":"Personnes privées de leur liberté par décision judiciaire ou administrative","language":10,"languageDescription":"French"}]},{"id":1373178,"number":17,"principalExclusionCriteria":"Persons under legal protection (guardianship, curatorship)","principalExclusionCriteriaTranslations":[{"id":9799888,"uuid":"39f5087f-b217-48f1-a5fb-8714bb9de11b","attributeTranslation":"Personnes sous protection juridique (tutelle, curatelle)","language":10,"languageDescription":"French"}]},{"id":1373179,"number":18,"principalExclusionCriteria":"Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants","principalExclusionCriteriaTranslations":[{"id":9799889,"uuid":"b4806ddc-c80d-4dd0-8615-9a7ceafd2598","attributeTranslation":"Participation à une autre étude interventionnelle impliquant la personne humaine ou être dans la période d'exclusion à la fin d'une précédente étude impliquant la personne humaine.","language":10,"languageDescription":"French"}]},{"id":1373180,"number":2,"principalExclusionCriteria":"High clinical suspicion of Complement-mediated aHUS (including familial history of aHUS)","principalExclusionCriteriaTranslations":[{"id":9799890,"uuid":"9e9a48fc-dfc4-4cc6-8794-f4df7c87a75e","attributeTranslation":"Forte suspicion clinique de SHUa médié par le complément (y compris antécédents familiaux de SHUa).","language":10,"languageDescription":"French"}]},{"id":1373181,"number":3,"principalExclusionCriteria":"High clinical suspicion of typical HUS (including Shiga Toxin-producing E. Coli infection) or Thrombotic thrombocytopenic purpura","principalExclusionCriteriaTranslations":[{"id":9799891,"uuid":"aa3c06c3-59d5-4c58-895d-0ef4ddef3025","attributeTranslation":"Forte suspicion clinique de SHU typique (y compris une infection à E. Coli producteur deshigatoxine) ou de purpura thrombocytopénique thrombotique.","language":10,"languageDescription":"French"}]},{"id":1373182,"number":4,"principalExclusionCriteria":"High clinical suspicion of secondary HUS related to autoimmune disease (including lupus, scleroderma, antiphospholipid syndrome, ANCA vasculitis), or C3 glomerulopathy.","principalExclusionCriteriaTranslations":[{"id":9799892,"uuid":"cac0a115-b5c0-4cb8-a5f0-4b522a80836d","attributeTranslation":"Forte suspicion clinique de SHU secondaire lié à une maladie auto-immune (y compris lupus, sclérodermie, syndrome des antiphospholipides, vascularite à ANCA), ou une glomérulopathie à C3.","language":10,"languageDescription":"French"}]},{"id":1373183,"number":5,"principalExclusionCriteria":"High clinical suspicion of recent constituted hemorrhagic or ischemic stroke justifying specific blood pressure targets","principalExclusionCriteriaTranslations":[{"id":9799893,"uuid":"d8205120-5cbf-406c-a3f7-e6058e6eef7d","attributeTranslation":"Forte suspicion clinique d'un accident vasculaire cérébral hémorragique ou ischémique récent justifiant des objectifs tensionnels spécifiques","language":10,"languageDescription":"French"}]},{"id":1373184,"number":6,"principalExclusionCriteria":"ADAMTS 13<10%, HIV or HCV infection, positivity of 2 markers among: anticardiolipin IgG/antiBeta2 GP1 IgG/lupus anticoagulant, positivity of ANCA (ELISA PR3 or MPO)","principalExclusionCriteriaTranslations":[{"id":9799894,"uuid":"5933db27-4c81-4069-8421-6a6cce0ac286","attributeTranslation":"ADAMTS 13<10%, infection par le VIH ou le VHC, positivité de 2 marqueurs parmi : IgG anticardiolipine/ IgG antiBeta2 GP1/ anticoagulant lupique, positivité des ANCA (ELISA PR3 ou MPO).","language":10,"languageDescription":"French"}]},{"id":1373185,"number":7,"principalExclusionCriteria":"Active infection","principalExclusionCriteriaTranslations":[{"id":9799895,"uuid":"b8b9086f-9ab6-4575-8448-ff5003630c85","attributeTranslation":"Infection active","language":10,"languageDescription":"French"}]},{"id":1373186,"number":8,"principalExclusionCriteria":"Subjects with unresolved Neisseria meningitidis infection","principalExclusionCriteriaTranslations":[{"id":9799896,"uuid":"42d50fa2-d1e3-4804-9630-a4f3b23dd55f","attributeTranslation":"Patients avec une infection à Neisseria meningitidis non résolue","language":10,"languageDescription":"French"}]},{"id":1373187,"number":9,"principalExclusionCriteria":"Subjects refusing Neisseria meningitidis vaccination or refusing antibioprophylaxis with oracillin (In case of penicillin allergy, antibioprophylaxis with macrolide couldbeproposed according to ANSM recommendations (azithromycin or roxithromycin))","principalExclusionCriteriaTranslations":[{"id":9799897,"uuid":"bb93b2ba-2e3b-460a-bd08-9931627f02b9","attributeTranslation":"Patients refusants la vaccination contre Neisseria meningitidis   ou refusants une antibioprophylaxie par oracilline (En cas d'allergie à la pénicilline, une antibioprophylaxie par macrolide pourra être proposée selon les recommandations de l'ANSM (azithromycine ou roxithromycine)).","language":10,"languageDescription":"French"}]}]},"endPoint":{"primaryEndPoints":[{"id":938753,"number":1,"endPoint":"Response to therapy, defined by the absence of any of the following events: i) at 6-month follow-up: persistent renal replacement therapy, eGFR<15ml/mn/1,73m2, or patient death; ii) at W2 : persistent hemolysis despite well conducted antihypertensive therapy. Any Eculizumab rescue in the control group will be considered as a failure.","isPrimary":true,"endPointTranslations":[{"id":9799871,"uuid":"b6d42e7f-9e9d-4b11-aa24-6725d74a580e","attributeTranslation":"Réponse au traitement définie par l'un des événements suivants : \ni) au suivi de 6 mois : traitement de substitution rénale persistant, DFGe <15ml/mn/1,73m2, ou décès du patient ; \nii) au jour 7 : hémolyse persistante malgré un traitement antihypertenseur bien mené. 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