NCT02302690已完成不适用
Study of the Prevalence of Pre-existing Immunity Against the Adeno-associated Virus (AAV) in Patients With Crigler-Najjar Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Genethon
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- To assess the presence of neutralizing AAV antibodies in the serum of CN patients
研究概览
简要总结
The proposed research protocol aims at addressing these points by pre-screening CN patients for their AAV serology in link with their medical history and current medical status. A first objective is to assess the presence of neutralizing AAV antibodies in the serum of CN patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a Crigler-Najjar syndrome
- •The molecular diagnosis has been confirmed by UGT1A1 gene DNA sequencing
- •Exclusion criteria:
- •The patient is liver transplanted
- •The patient is suffering from severe associated pathologies precluding further enrolment in a future interventional clinical study
排除标准
- 未提供
结局指标
主要结局
To assess the presence of neutralizing AAV antibodies in the serum of CN patients
时间窗: 1 day visit
次要结局
未报告次要终点
研究者
研究点 (1)
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