NCT05580692终止不适用
A Multinational, Multi-center, Prospective Cohort Study Evaluating Seroprevalence and Seroconversion of Antibodies Against Adeno-associated Virus (AAV) Serotypes in Subjects With Hemophilia A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 321
- 试验地点
- 35
- 主要终点
- To qunatify Seroprevalence of antibodies to selected AAV serotypes
研究概览
简要总结
A prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes
详细描述
This is a multinational, multi-center, prospective cohort study utilizing biospecimen sample collection from adult Hemophilia A subjects to evaluate and characterize seroprevalence and the seroconversion of antibodies against AAV serotypes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Subjects with Hemophilia A
排除标准
- •Subject previously treated with AAV vector gene therapy
结局指标
主要结局
To qunatify Seroprevalence of antibodies to selected AAV serotypes
时间窗: 52 weeks
Number of patients with detectable antibodies to selected AAV serotypes
次要结局
- To describe and characterize selected AAV serotypes antibody responses in adult subjects with Hemophilia A(52 weeks)
研究者
研究点 (35)
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