1
Clinical Trials associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)评价静注人免疫球蛋白(10%)治疗原发免疫性血小板减少症的有效性和安全性的开放、单臂、多中心临床试验
[Translation] An open, single-arm, multicenter clinical trial to evaluate the efficacy and safety of intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia
主要目的: 评价新型静注人免疫球蛋白(10%)治疗原发免疫性血小板减少症(ITP)的疗效,通过分析首次用药治疗后7天内受试者血小板计数≥30×109/L并且提高到基线2倍以上的受试者比例,评价贵州泰邦生物制品有限公司生产的静注人免疫球蛋白(10%)的疗效。 次要目的: 1)通过其它次要疗效指标,观察和评价疗效差异; 2)观察和评价安全性。
[Translation] Primary purpose: To evaluate the efficacy of new intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia (ITP), and to evaluate the efficacy of intravenous human immunoglobulin (10%) produced by Guizhou Taibang Biological Products Co., Ltd. by analyzing the proportion of subjects with platelet count ≥30×109/L and increased to more than 2 times the baseline within 7 days after the first medication. Secondary objectives: 1) Observe and evaluate the difference in efficacy through other secondary efficacy indicators; 2) Observe and evaluate safety.
100 Clinical Results associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)
100 Translational Medicine associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)
100 Patents (Medical) associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)
100 Deals associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)