[Translation] A Phase IIIb, prospective, open-label, multicenter, single-arm, continuation study evaluating the safety and efficacy of TAK-755 (rADAMTS-13, also known as BAX 930/SHP655) as a preventive and on-demand treatment in subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP; Upshaw-Schulman syndrome or hereditary thrombotic thrombocytopenic purpura)
主要目的:
从治疗中出现的相关不良事件 (AE) 和严重不良事件 (SAE) 方面评价 TAK-755 (rADAMTS-13) 在预防性治疗队列和按需治疗队列中的长期安全性和耐受性。
[Translation] Primary objective:
To evaluate the long-term safety and tolerability of TAK-755 (rADAMTS-13) in both the preventive and on-demand treatment cohorts in terms of treatment-emergent adverse events (AEs) and serious adverse events (SAEs).