A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B

CSL Behring GmbH0 个研究点目标入组 60 人开始时间: 2012年3月29日最近更新: 2017年8月28日

适应症

试验速览

暂无简介。

•Male subjects, 12 to 65 years old.
•Severe hemophilia B (FIX activity of = 2%).
•Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for > 150 exposure days (EDs).
•No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX.
•Written informed consent for study participation.
•On-demand subjects only, who have experienced a minimum average of 2 non-trauma induced bleeding episodes requiring treatment with a FIX product during the previous 6 or 3 months.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 3
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•Known hypersensitivity to any FIX product or hamster protein.
•Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
•HIV positive subjects with a CD4 count < 200/mm3.
•Low platelet count, kidney or liver dysfunction.
•Recent life-threatening bleeding episode.

发起方