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Clinical Trials associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)评价静注人免疫球蛋白(pH4)治疗原发免疫性血小板减少症(ITP)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 (pH4) in the treatment of primary immune thrombocytopenia (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(pH4)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,AE(和SAE)的发生率和严重程度。
[Translation] Primary objective: To evaluate the efficacy of intravenous human immunoglobulin (pH4) in the treatment of primary immune thrombocytopenia (ITP) by improving the effective rate of platelets. Secondary objectives: (1) To observe and evaluate the efficacy through other secondary efficacy indicators; (2) To observe and evaluate safety, including clinical symptoms and signs, laboratory indicators, and the incidence and severity of AEs (and SAEs).
评价静注人免疫球蛋白(10%)在成年及青少年(≥12岁)中治疗原发免疫性血小板减少症有效性和安全性的开放、单臂、多中心Ⅲ期临床研究
[Translation] An open, single-arm, multicenter phase III clinical study to evaluate the efficacy and safety of intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia in adults and adolescents (≥12 years old)
主要目的:
评价静注人免疫球蛋白(10%)在成年及青少年(≥12岁)中治疗原发免疫性血小板减少症(ITP)的疗效,通过分析首次输注治疗后7天内受试者血小板计数≥30×109/L且提高到基线2倍以上的受试者比例,评价博雅生物制药集团股份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;2)观察和评价安全性。
[Translation] Primary purpose:
To evaluate the efficacy of intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia (ITP) in adults and adolescents (≥12 years old), and to evaluate the efficacy of intravenous human immunoglobulin (10%) produced by Boya Biopharmaceutical Group Co., Ltd. by analyzing the proportion of subjects with platelet counts ≥30×109/L and increased to more than 2 times the baseline within 7 days after the first infusion.
Secondary purpose:
1) Observe and evaluate the efficacy through other secondary efficacy indicators; 2) Observe and evaluate safety.
100 Clinical Results associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)
100 Translational Medicine associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)
100 Patents (Medical) associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)
100 Deals associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)