1
Clinical Trials associated with Human antithrombin III(Sichuan Yuanda Shuyang Pharmaceuticalc) / Not yet recruitingPhase 1 评价人抗凝血酶Ⅲ预防治疗先天性抗凝血酶Ⅲ缺乏患者的有效性、安全性以及药代动力学的临床试验
[Translation] Clinical trial to evaluate the efficacy, safety and pharmacokinetics of human antithrombin III in the prevention and treatment of patients with congenital antithrombin III deficiency
本试验分2个阶段开展,试验目的如下:
阶段1:
1) 评价人抗凝血酶Ⅲ在成人及青少年先天性抗凝血酶Ⅲ缺乏症患者中单次给药的安全性;
2) 评价人抗凝血酶Ⅲ在成人及青少年先天性抗凝血酶Ⅲ缺乏症患者中单次给药的药代动力学(PK)特征。
阶段2:
评价人抗凝血酶Ⅲ在计划进行择期手术或者分娩的先天性抗凝血酶Ⅲ缺乏患者中预防发生静脉血栓栓塞并发症的有效性和安全性。
[Translation] This trial was conducted in two phases with the following objectives:
Phase 1:
1) To evaluate the safety of a single dose of human antithrombin III in adults and adolescents with congenital antithrombin III deficiency;
2) To evaluate the pharmacokinetic (PK) characteristics of a single dose of human antithrombin III in adults and adolescents with congenital antithrombin III deficiency.
Phase 2:
To evaluate the effectiveness and safety of human antithrombin III in preventing venous thromboembolic complications in patients with congenital antithrombin III deficiency who are planning elective surgery or delivery.
100 Clinical Results associated with Human antithrombin III(Sichuan Yuanda Shuyang Pharmaceuticalc)
100 Translational Medicine associated with Human antithrombin III(Sichuan Yuanda Shuyang Pharmaceuticalc)
100 Patents (Medical) associated with Human antithrombin III(Sichuan Yuanda Shuyang Pharmaceuticalc)
100 Deals associated with Human antithrombin III(Sichuan Yuanda Shuyang Pharmaceuticalc)