A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients with atypical Hemolytic Uremic Syndrome (aHUS) - BO42353

F. Hoffmann-La Roche AG0 个研究点目标入组 81 人开始时间: 2024年1月25日最近更新: 2024年7月22日

研究概览

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•Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment in accordance with current local guidelines or standard of care, as applicable in patients with complement deficiency (for ALL cohorts), Adequate hepatic function, AST and ALT = 3×ULN at the time of screening; no clinical signs or known laboratory/radiographic evidence consistent with cirrhosis (for ALL cohorts), For female patients of childbearing potential, an agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (for ALL cohorts), Onset of initial TMA presentation, within 28 days prior to the first dose of crovalimab (For naïve cohort only), Clinical evidence of response to either eculizumab or ravulizumab, as documented by a platelet count =LLN, LDH =ULN, and stable (decrease or increase of =20%) or improving creatinine at two consecutive measurements at least 4 weeks apart prior to Week 1 Day 1 of crovalimab treatment. (For switch cohort only), Known C5 polymorphism (e.g., Arg885) (For C5SNP cohort only)

•TMA associated with non-aHUS-related renal disease, History of a kidney disease other than aHUS, affecting renal function, Known systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome, Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration, History of Neisseria meningitidis infection within 6 months of study enrollment, History of malignancy within 5 years prior to screening and up to the first crovalimab administration

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