Traitement précoce de patients pédiatriques présentant un syndrome hémolytique et urémique typique par l’anticorps monoclonal anti-C5 eculizumab : essai thérapeutique prospectif randomisé contrôlé contre placebo de phase III

Centre Hospitalier de Toulouse0 个研究点目标入组 100 人开始时间: 2014年7月31日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•Pediatric patient (1 month-18 years old)
•. Affected by STEC-HUS defined by:
•- Thrombocytopenia (<150 000/mm3)
•- Mechanic hemolytic anemia (Hemoglobin < 10g/dL, haptoglobin ULN and/or bilirubine >ULN, presence of schizocytes)
•- ARF defined by an estimated Schwartz 2009 creatinin clairance <75ml/min/1,73m²
•- With prodromal diarrhea and/or presence of an enterohemorragic strain of Escherichia Coli and/or identification of the Stx 1 or 2 genes in the stool sample or rectal swab
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•. Neonatal HUS
•. Malignancy
•. Known HIV infection
•. Pregnancy or lactation
•. Identified drug exposure-related HUS
•. Infection-related HUS
•. Known systemic lupus erythematosus or antiphospholid antibody positivity or syndrome
•. Patient already enrolled in a drug trial
•. Patient with ongoing meningococcal infection
•. Patient affected by aHUS or family history of aHUS
•. STEC-HUS patient with severe multiorgan involvement at diagnostic:
•Neurological involvement (seizures, coma, focal deficit) with signs of microangiopathy on cerebral Magnetic Resonance Imaging.
•Cardiac involvement (cardiac failure, ischemic myocarditis, conduction or rhythm troubles)
•Digestive involvement (severe pancreatitis defined by lipasemia>500UI/L, severe hepatitis defined by transaminase >x10ULN and/or prothrombin time<60%, hemorrhagic colitis, bowel perforation, rectal prolapsus)

发起方

Centre Hospitalier de Toulouse