NCT04976231招募中不适用
Immunophenotyping of Patients With MPS II Treated With Enzyme Replacement Therapy
Duke University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes in level of T follicular helper cells measured by flow cytometry
研究概览
简要总结
The purpose of this study is to investigate how participant's body's immune system responds to idursulfase, an enzyme replacement therapy (ERT) and find out which types of immune cells are involved in causing untoward responses to the ERT so that the investigators can relate the level of immune response to the treatment.
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
- •Subject has a confirmed diagnosis of Mucopolysaccharidosis type II (MPS II) or Hunter Syndrome based on enzyme activity and variant analysis.
- •Subject who plan to receive or have received enzyme replacement therapy with idursulfase.
排除标准
- 未提供
结局指标
主要结局
Changes in level of T follicular helper cells measured by flow cytometry
时间窗: baseline, 1, 3, 6 months
Changes in level of circulation memory B cells measured by flow cytometry
时间窗: baseline, 1, 3, 6 months
Changes in distribution of helper T cells measured by flow cytometry
时间窗: baseline, 1, 3, 6 months
Changes in the frequency of natural killer cells measured by flow cytometry
时间窗: baseline, 1, 3, 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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