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项与 人免疫球蛋白(pH4)(远大蜀阳药业) 相关的临床试验评价皮下注射人免疫球蛋白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特征的单臂、开放、多中心临床试验
临床疗效期研究
主要目的:
评价远大蜀阳生命科学 (成都) 有限公司生产的皮下注射人免疫球蛋白 (SCIG)
治疗原发性免疫缺陷病(PID)的有效性。
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。
药代动力学研究
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,
分析获得药物的动力学特征,以及 IVIG 和 SCIG 剂量调整因子(DAF) 。
次要目的:
分析试验期间 IVIG 和 SCIG 总 IgG 谷浓度水平。
评价静注人免疫球蛋白(10%)治疗原发免疫性血小板减少症(ITP)患者有效性和安全性的开放、单臂、多中心Ⅲ期临床研究
主要目的是通过提升血小板的有效率,评价静注人免疫球蛋白(10%)治疗原发免疫性血小板减少症(ITP)的疗效。次要目的是通过其它次要疗效指标,观察和评价疗效;同时观察和评价安全性,包括临床症状体征观察和实验室指标,不良事件的发生率和严重程度。
Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG in Patients With Primary Immunodeficiency
To evaluate the safety, efficacy, and pharmacokinetic properties of Shu Yang intravenous immune globulin in patients with primary immune deficiency aged less than 60 years.
The main benefit of IVIG is to help the body fight against a large variety of infections generally associated with morbidity and mortality in patients with primary immunodeficiency diseases, particularly in CVID and XLA. In addition, a decrease in the number of infections, a reduction in medications and hospitalizations, and a better quality of life are expected.
Throughout treatment, approximately one-fourth of persons may experience a side effect. These are usually mild or bothersome but not dangerous. Very rarely, more serious side effects like allergic reactions or low blood counts (anemia) can occur. One of the most common side effects is headache. Other side effects include chills, fever, flushing, flu-like muscle pains or joint pains, feeling tired, nausea, vomiting, and rash. For the most part, these reactions typically happen with the first dose of IVIG or because change to a different brand of IVIG. All IVIG products have similar warnings and contraindications, such as the potential for renal failure, thrombotic events, aseptic meningitis, hemolysis, and anaphylactic reactions.
100 项与 人免疫球蛋白(pH4)(远大蜀阳药业) 相关的临床结果
100 项与 人免疫球蛋白(pH4)(远大蜀阳药业) 相关的转化医学
100 项与 人免疫球蛋白(pH4)(远大蜀阳药业) 相关的专利(医药)
100 项与 人免疫球蛋白(pH4)(远大蜀阳药业) 相关的药物交易