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临床试验/NCT05580692
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

BioMarin Pharmaceutical35 个研究点 分布在 8 个国家目标入组 321 人开始时间: 2023年3月14日最近更新:
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

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

申办方类型
Industry
责任方
Sponsor

研究点 (35)

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