[Translation] A prospective clinical study to evaluate the clinical efficacy, immunogenicity, pharmacokinetics and safety of human recombinant factor VIII in Chinese patients with severe hemophilia A
评估Human-cl rhFVIII预防和治疗出血事件(BE)的临床效果。确定的药代动力学特征,测定增量体内回收率-在研究开始时和随着时间的推移,研究潜在免疫原性,评估Human-cl rhFVIII作为手术预防药物的效果,评估安全性。
[Translation] To evaluate the clinical efficacy of Human-cl rhFVIII in the prevention and treatment of bleeding events (BE). To define pharmacokinetic characteristics, determine incremental in vivo recovery - at study entry and over time, investigate potential immunogenicity, evaluate the efficacy of Human-cl rhFVIII as a surgical prophylaxis, and assess safety.