PHASE I/II STUDY IN PREVIOUSLY TREATED SEVERE HEMOPHILIA B

既往治疗过的严重 B 型血友病的 I/II 期研究

• 批准号: 5221178
• 负责人: AMY SHAPIRO
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5221178
• 关键词: clinical research; clinical trial phase I; coagulation factor IX; hemophilia B; human subject; human therapy evaluation; pharmacokinetics; recombinant proteins

This study is a three segment study, Phase 1/2 study of the use of recombinant factor IX in severe factor IX deficient patients that have previously been treated with factor therapies made from pooled human plasma. It involves a double-blinded randomized crossover evaluation of the pharmacokinetics including a recovery and half-life study of rhFIX and Mononine, an open-label, on demand treatment of bleeding episodes using rhFIX; and intra- and postoperative treatment using rhFIX.

本研究为三段研究，采用1/2期研究