一项在慢性原发性免疫性血小板减少症受试者中评价Mezagitamab皮下注射的有效性和安全性的III期、随机、双盲、安慰剂对照研究
[Translation] A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Mezagitamab in Subjects with Chronic Primary Immune Thrombocytopenia
本研究由Takeda Development Center Americas, Inc.和武田亚太生物医药研发有限公司申办的一项在慢性原发性免疫性血小板减少症受试者中评价 Mezagitamab 皮下注射的有效性和安全性的 III 期、随机、 双盲、安慰剂对照研究。研究的主要目的为:评估 mezagitamab 相比安慰剂在年龄≥18 岁的慢性 ITP 受试者实现持久血小板应答的有效性。研究预计在中国筛选50例受试者,入组30例受试者。
[Translation] This study is a Phase III, randomized, double-blind, placebo-controlled study sponsored by Takeda Development Center Americas, Inc. and Takeda Biopharmaceuticals Asia Pacific to evaluate the efficacy and safety of subcutaneous mezagitamab in subjects with chronic primary immune thrombocytopenia. The primary objective of the study is to evaluate the effectiveness of mezagitamab compared with placebo in achieving sustained platelet response in subjects with chronic ITP aged ≥18 years. The study is expected to screen 50 subjects in China and enroll 30 subjects.
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