Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 16
- 主要终点
- Determination of HLA Type
研究概览
简要总结
This study is conducted globally. This study describes pharmacogenetic testing of saliva samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before collection of saliva samples
- •Previous participation in adept™2 trial with 5 or more exposure days to rFVIIa analogue
排除标准
- 未提供
结局指标
主要结局
Determination of HLA Type
时间窗: Up to 12 months
HLA typing includes up to 8 different HLA types (HLA-DRB1/B3/B4/B5, DPA1/B1 and DQA1/B1) and their most likely alleles. Number of participants with most likely HLA allele are reported.
Determination of Polymorphisms in the FVII Gene
时间窗: Up to 12 months
Determination of polymorphisms in the FVII gene in patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa.
次要结局
未报告次要终点