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Clinical Trials associated with Human immunoglobulin(Chengdu Rongsheng Pharmaceutical 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.
评价皮下注射人免疫球蛋白(注射液)在原发性免疫缺陷病(PID)患者中的有效性、安全性及药代动力学的单臂、多中心临床试验
[Translation] A single-arm, multicenter clinical trial to evaluate the efficacy, safety, and pharmacokinetics of subcutaneous human immunoglobulin (injection) in patients with primary immunodeficiency disease (PID)
药代动力学研究
1. 主要目的
通过药代动力学研究建立IVIG和SCIG的群体药代动力学(popPK)模型,获得药物的动力学特征,以及IVIG和SCIG剂量调整因子(Dose adjustment factor,DAF)。
2. 次要目的
分析试验期间IVIG和SCIG总IgG谷浓度水平。
临床疗效期研究
1. 主要目的
评价成都蓉生药业有限责任公司生产的皮下注射人免疫球蛋白(注射液)治疗原发性免疫缺陷病(PID)的有效性。
2. 次要目的
1) 采用临床次要疗效指标,进一步观察和评价SCIG的临床疗效。
2) 观察和评价试验期间SCIG的安全性。
[Translation] Pharmacokinetic study
1. Main purpose
To establish the population pharmacokinetic (popPK) model of IVIG and SCIG through pharmacokinetic study, obtain the kinetic characteristics of the drugs, and the dose adjustment factor (DAF) of IVIG and SCIG.
2. Secondary purpose
To analyze the trough concentration level of total IgG of IVIG and SCIG during the trial.
Clinical efficacy phase study
1. Main purpose
To evaluate the effectiveness of subcutaneous human immunoglobulin (injection) produced by Chengdu Rongsheng Pharmaceutical Co., Ltd. in the treatment of primary immunodeficiency disease (PID).
2. Secondary purpose
1) To further observe and evaluate the clinical efficacy of SCIG using clinical secondary efficacy indicators.
2) To observe and evaluate the safety of SCIG during the trial.
静注人免疫球蛋白治疗原发免疫性血小板减少症患者有效性和安全性的开放、多中心临床研究
[Translation] An open, multicenter clinical study on the efficacy and safety of intravenous human immunoglobulin in the treatment of patients with primary immune thrombocytopenia
主要目的: 评价静注人免疫球蛋白(pH4、10%)(层析法)治疗原发免疫性血小板减少症(primary immune thrombocytopenia,ITP)患者的有效性。 次要目的: 评价静注人免疫球蛋白(pH4、10%)(层析法)治疗原发免疫性血小板减少症(primary immune thrombocytopenia,ITP)患者的安全性。
[Translation] Primary objective: To evaluate the effectiveness of intravenous human immunoglobulin (pH 4, 10%) (chromatographic method) in the treatment of patients with primary immune thrombocytopenia (ITP). Secondary objective: To evaluate the safety of intravenous human immunoglobulin (pH 4, 10%) (chromatographic method) in the treatment of patients with primary immune thrombocytopenia (ITP).
100 Clinical Results associated with Human immunoglobulin(Chengdu Rongsheng Pharmaceutical Co., Ltd.)
100 Translational Medicine associated with Human immunoglobulin(Chengdu Rongsheng Pharmaceutical Co., Ltd.)
100 Patents (Medical) associated with Human immunoglobulin(Chengdu Rongsheng Pharmaceutical Co., Ltd.)
100 Deals associated with Human immunoglobulin(Chengdu Rongsheng Pharmaceutical Co., Ltd.)