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MechanismFibrinogen stimulants |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date09 Jul 2020 |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.South Korea |
First Approval Date09 Jan 2012 |
一项在中国黏多糖贮积症II型儿童患者中评估艾度硫酸酯酶β注射液安全性和有效性的上市后研究
[Translation] A post-marketing study evaluating the safety and efficacy of idoosulfatase beta injection in pediatric patients with mucopolysaccharidosis type II in China.
主要目的:
评估艾度硫酸酯酶β注射液治疗中国黏多糖贮积症II型(MPS II)儿童患者的安全性
次要目的:
1、 评估中国MPSⅡ患者接受艾度硫酸酯酶β注射液治疗后患者尿糖胺聚糖(uGAG)较基线的变化
2、 评估中国MPSⅡ患者接受艾度硫酸酯酶β注射液治疗后患者肝脏和脾脏体积较基线的变化百分比
[Translation] Primary Objective: To evaluate the safety of idolisulfate beta injection in Chinese pediatric patients with mucopolysaccharidosis type II (MPS II).
Secondary Objectives:
1. To assess the change in urinary glycosaminoglycans (uGAG) levels from baseline in Chinese MPS II patients treated with idolisulfate beta injection.
2. To assess the percentage change in liver and spleen volume from baseline in Chinese MPS II patients treated with idolisulfate beta injection.
评价人纤维蛋白原在先天性纤维蛋白原减少或缺乏症患者中的有效性和安全性的上市后临床研究
[Translation] Post-marketing clinical study to evaluate the efficacy and safety of human fibrinogen in patients with congenital fibrinogen deficiency or deficiency
1)通过单次给药的简易PK研究,探索本品的部分关键药代动力学(PK)特征,为本品用量计算提供依据;
2)评价本品在上市后治疗先天性纤维蛋白原减少或缺乏症患者的有效性和安全性。
[Translation] 1) Through a simple PK study of a single dose, explore some key pharmacokinetic (PK) characteristics of this product to provide a basis for the dosage calculation of this product;
2) Evaluate the efficacy and safety of this product in the treatment of patients with congenital fibrinogen deficiency or deficiency after marketing.
/ Not yet recruitingPhase 3 评价静注人免疫球蛋白(pH4)治疗原发免疫性血小板减少症有效性和安全性的临床研究
[Translation] Clinical study to evaluate the efficacy and safety of intravenous human immunoglobulin (pH4) in the treatment of primary immune thrombocytopenia
以原生产工艺静注人免疫球蛋白(pH4)对照,评价静注人免疫球蛋白(pH4)治疗原发免疫性血小板减少症的有效性和安全性。
[Translation] To evaluate the efficacy and safety of intravenous human immunoglobulin (pH4) in the treatment of primary immune thrombocytopenia, using the original production process of intravenous human immunoglobulin (pH4) as a control.
100 Clinical Results associated with Green Cross China Biological Products Co., Ltd.
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