Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- to examine host genetic variation and possible genetic susceptibility to PML
研究概览
简要总结
The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus (JCV).
详细描述
Deoxyribonucleic acid (DNA) will be analyzed from natalizumab-treated subjects who develop Progressive Multifocal Leukoencephalopathy (PML). The genetic analysis of the subjects will directly seek mutations that could identify subjects at risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Subjects who have confirmed PML while on treatment with Natalizumab
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
排除标准
- 未提供
结局指标
主要结局
to examine host genetic variation and possible genetic susceptibility to PML
时间窗: Up to 3 Months
次要结局
- To explore predisposing factors of the innate and adaptive immune system(Up to 3 Months)
- optional substudy: to test alterations in DNA repair pathways(Up to 3 Months)
- To analyze DNA sequences of JCV(Up to 3 Months)