Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- CYP4F2 polymorphism frequency in case and control groups
研究概览
简要总结
To investigate whether polymorphic differences can be identified between Multiple Sclerosis patients developing elevated liver enzymes (defined as ALT, AST, GGT or bilirubinemia levels five above the upper normal limit on at least one) compared to those not developing elevated liver enzymes after exposure to fingolimod for multiple sclerosis.
详细描述
PURPOSE: To investigate whether polymorphic differences can be identified between Multiple sclerosis (MS) patients treated by fingolimod who had liver enzymes elevation compared to those who do not.
OBJECTIVE: To determine whether elevated liver enzyme tests (ALT, AST, GGT or bilirubinemia above the upper limit of normal) in MS patients treated with fingolimod is associated with genetic polymorphisms.
METHOD OF RECRUITMENT:
Patients will be identified through a clinic database and chart reviews. A phone call will be made to determine interest. Upon a follow-up neurological consultation, consent into study will be sought.
PROCEDURES:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Adults (> 18 years)
- •Have a definite Multiple Sclerosis with a relapsing-remitting course (McDonald criteria)
- •Treated with fingolimod
- •Have given consent and signed an informed consent form
排除标准
- •an elevated liver test result on baseline before starting fingolimod treatment
- •presence of a viral, hereditary or auto-immune liver pathology
- •Time of fingolimod exposure lower than three months
- •Woman currently pregnant or breastfeeding
结局指标
主要结局
CYP4F2 polymorphism frequency in case and control groups
时间窗: At inclusion
Proportion of CYP4F2 polymorphism in case and control groups
次要结局
- Fingolimod concentrations in case and control groups(At inclusion)
- Fingolimod-phosphate concentrations in case and control groups(At inclusion)