A Phase 2/3, multicenter, open-label clinical study to assess the safety and efficacy of BAY86-6150 in subjects with hemophilia A or B with inhibitors, composed of 2 Parts (A & B). Part A: Sequential cohorts of four dose levels of the modified rFVIIa BAY 86-6150 assessed in a non-controlled dose response design in acutely bleeding subjects and for PK/ PD in an intra-individual crossover design compared with one fixed dose of eptacog alfa (activated) in non-bleeding subjects. Part B: Confirmatory study to further investigate the efficacy and safety of BAY 86-6150. - A Phase 2/ 3 trial to evaluate the efficacy and safety of BAY86-6150

Bayer HealthCare AG0 个研究点目标入组 65 人开始时间: 2012年5月14日最近更新: 2013年5月27日

适应症

试验速览

暂无简介。

•- Male subjects
•- 12 to 62 years-of-age
•- History of moderate or severe congenital hemophilia A or B with inhibitors to FVIII or FIX
•- 4 or more bleeding episodes in the last 6 months before enrollment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Clinically relevant coagulation disorder other than congenital hemophilia A or B with inhibitors
•- History of coronary and/or peripheral atherosclerotic disease
•- Disseminated intravascular coagulopathy, or stage 2 hypertension
•- Angina pectoris
•- Myocardial infarction
•- Transient ischemic attack
•- Congestive heart failure
•- Thromboembolic event

发起方