[Translation] An open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of eculizumab in Chinese adult subjects with paroxysmal nocturnal hemoglobinuria (PNH) who were first treated with complement inhibitors
主要目的:评估依库珠单抗在PNH受试者中的疗效
次要目的:①评估依库珠单抗在PNH受试者中的安全性和耐受性;②描述依库珠单抗在PNH受试者中的药代动力学特征;③描述依库珠单抗在PNH受试者中的药效学特征;④描述依库珠单抗在PNH受试者中的免疫原性特征;
其他次要目的:①通过其他指标评价依库珠单抗在PNH受试者中的疗效;②通过其他安全性指标描述依库珠单抗在PNH受试者中的安全性特征
[Translation] Primary purpose: To evaluate the efficacy of eculizumab in PNH subjects
Secondary purposes: ① To evaluate the safety and tolerability of eculizumab in PNH subjects; ② To describe the pharmacokinetic characteristics of eculizumab in PNH subjects; ③ To describe the pharmacodynamic characteristics of eculizumab in PNH subjects; ④ To describe the immunogenicity characteristics of eculizumab in PNH subjects;
Other secondary purposes: ① To evaluate the efficacy of eculizumab in PNH subjects by other indicators; ② To describe the safety characteristics of eculizumab in PNH subjects by other safety indicators