NL-OMON54158已完成2 期
A Phase I/IIb extension study assessing the long-term safety and efficacy of an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) previously administered to adult patients with severe or moderately severe haemophilia B during the CT-AMT-060-01 Phase I/II study. - Extension study of AAV5-hFIX in severe/moderately severe haemophilia B
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1. Subjects with congenital hemophilia B who completed Study CT-AMT-060-01
- •2. Able to provide informed consent following receipt of verbal and written
- •information about the trial.
排除标准
- •Enrolled subjects will have already been assessed based on the exclusion
- •criteria for Study CT-AMT-060-01.
研究者
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