EUCTR2012-005489-37-ES进行中（未招募）1 期
A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 97
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •? Male subjects, up to 65 years old
- •? Participated in a CSL-sponsored rIX-FP (CSL654) study, including study CSL654_3001 or study CSL654_3002.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Unwilling to participate in the study for a total of 100 exposure days.
- •? Currently receiving a therapy not permitted during the study.
- •? Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the study.
研究者
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