CTRI/2012/05/002708已完成3 期
An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Haemophilia B
Biogen Idec United Kingdom3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年6月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.
研究概览
简要总结
This is an open-label, multicenter, long-term study of intravenous (IV) administration of rFIXFc in previously treated patients with hemophilia B, who completed the B-LONG study (998HB102), the pediatric study (9HB02PED), or any other Phase 3 trial with rFIXFc. Treatment will be administered as prophylactic or on-demand regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Parental or guardian consent is required for subjects who are less than 18 years of age or unable to give consent, or as applicable per local laws.
- •Subjects who are less than 18 years of age may provide assent in addition to the parental/guardian consent, if appropriate.
- •Subjects who have completed the studies 998HB102, 9HB02PED, or other Phase 3 studies with rFIXFc.
排除标准
- •Confirmed positive high-titer inhibitor test (≥5.00 BU/mL)
- •Medical or other reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.
结局指标
主要结局
The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.
时间窗: 4 years
次要结局
- number of bleeding episodes per subject(Time Frame up to four years)
研究者
研究点 (3)
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