EUCTR2020-000739-28-DK进行中（未招募）1 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. - Phase I/IIb extension study of AAV5-hFIX in severe or moderately severe haemophilia B
uniQure biopharma B.V.0 个研究点目标入组 10 人开始时间: 2020年10月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- •1. Patients 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Enrolled patients will have already been assessed based on the exclusion criteria for Study CT-AMT-060-01.
研究者
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