Clinical trial analysis of recombinant human coagulation factor Ⅶ
At present,a number of pharmaceutical companies use gene recombinant technology to develop products of recombinant human coagulation factor Ⅶ,of which NovoSeven and Sevenfact have been approved for market.China has a number of products of recombinant coagulation factor Ⅶ in the research and development stage entering the clinical trial stage.This paper briefly introduces the clinical trials of NovoSeven and Sevenfact,focusing on the key elements of their clinical trial design for hemophilia A and hemophilia B,including the sequence of clinical trials,pharmacokinetic and pharmacodynamics studies,drug administration regimen exploration,efficacy evaluation indicators,and safety evaluation concerns,etc.It is hoped that domestic pharmaceutical enterprises can learn from their research and development experience,combine their own characteristics and clinical actual situation,complete reasonable clinical trial scheme design and obtain enough clinical trial data,and then fully explain the efficacy and safety characteristics of the product,and finally realize the successful development of domestic recombinant human coagulation factor Ⅶ.
NETL
NSTL
万方数据
