[Translation] An open-label, single-arm, multicenter phase III clinical trial evaluating the efficacy and safety of intravenous immunoglobulin (10%) in the treatment of primary immune thrombocytopenic purpura (ITP).
主要目的:通过提升血小板的有效率,评价静注人免疫球蛋白(10%)治疗原发免疫性血小板减少症(ITP)的疗效。
次要目的:1)通过其它次要疗效指标,观察和评价疗效;2)观察和评价安全性,包括临床症状体征观察和实验室指标,不良事件的发生率和严重程度。
[Translation] Primary objective: To evaluate the efficacy of intravenous immunoglobulin (10%) in the treatment of primary immune thrombocytopenic purpura (ITP) by improving platelet count.
Secondary objectives: 1) To observe and evaluate efficacy using other secondary efficacy endpoints; 2) To observe and evaluate safety, including observation of clinical signs and symptoms and laboratory indicators, incidence and severity of adverse events.