EUCTR2017-005080-40-GB进行中（未招募）1 期
An Open-Label, Multicentre, Long-Term Follow-Up Study to Investigate the Safety and Durability of Response Following Dosing of a Novel Adeno-Associated Viral Vector (FLT180a) in Patients with Haemophilia B
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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 who have previously received FLT180a within a clinical study.
- •2. Able to give full informed consent and able to comply with all requirements of the study including long-term follow-up for the timeframe the study requires.
- •3. Willing to practice barrier contraception until at least 3 consecutive semen samples after vector administration are negative for vector sequence*.
- •*only applicable if vector genome shedding in semen sample persists at end of study in the preceding clinical study where FLT180a is administered.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •None, if both inclusion criteria are met
研究者
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