CTRI/2010/091/002949已完成2 期
B-LONG: An Open-label, Multicenter Evaluation of the Safety,Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc fusion (rFIXFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With SevereHemophilia B
Biogen Idec ltd Innovation House Norden RoadMaidenheadBerkshireSL AY United Kingdom0 个研究点目标入组 75 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and 12 years of age and older and weigh at least 40 kg.
- •Diagnosed with hemophilia B (baseline Factor IX level less than or equal to 2%).
- •History of at least 100 exposure days to any Factor IX product.
- •Platelet count ≥100,000 cells/μL.
排除标准
- •History of Factor IX inhibitors.
- •Kidney or liver dysfunction.
- •Diagnosed with another coagulation defect other than hemophilia B.
- •Prior history of anaphylaxis associated with any FIX or IV immunoglobulin administration.
研究者
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