[Translation] Efficacy and safety of avatrombopag in the treatment of chronic immune thrombocytopenia (ITP) in Chinese adults: a multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial with extension study
主要:确定第6周的血小板反应率,证明阿伐曲泊帕对中国成人慢性ITP患者的疗效优于安慰剂。次要:根据所测量的第8天的血小板反应,证明阿伐曲泊帕优效于安慰剂。根据6周内所测定血小板反应率累积周数(定义为:在无补救治疗情况下,血小板计数≥50×109/L的累计周数),证明阿伐曲泊帕优效于安慰剂。评估阿伐曲泊帕在减少出血和补救治疗方面的疗效优于安慰剂。评估阿伐曲泊帕长期治疗的有效性。评估阿伐曲泊帕安全性和耐受性。
[Translation] Primary: To determine the platelet response rate at week 6 and to demonstrate that avatrombopag is superior to placebo in Chinese adult patients with chronic ITP. Secondary: To demonstrate the superiority of avatrombopag over placebo based on the platelet response measured at day 8. To demonstrate the superiority of avatrombopag over placebo based on the cumulative number of weeks with platelet response rate measured within 6 weeks (defined as the cumulative number of weeks with platelet count ≥50×109/L in the absence of rescue therapy). To assess the superiority of avatrombopag over placebo in reducing bleeding and rescue therapy. To assess the effectiveness of long-term treatment with avatrombopag. To assess the safety and tolerability of avatrombopag.