Effectiveness of Tailored Therapeutic Model According to the Expression of Genes Related to Immunomodulator-induced Myelosuppression in Inflammatory Bowel Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 5
- 主要终点
- Cumulative incidence of myelosuppression
研究概览
简要总结
This study is a randomized controlled study conducted at five tertiary university hospitals. Patients who are 20-80 years old, diagnosed as having Inflammatory Bowel Disease(IBD) and who are planned to start thiopurines for the first time for the treatment of IBD are enrolled. Patients are assigned to the genotyping group or to the non-genotyping group. The patients who carry any heterozygotic variant among the three genes receive 50 mg azathioprine (AZA) or 25 mg of 6-mercaptopurine, while those who have any homozygotic variant are recommended to take other alternative drugs. The patients who do not carry any genetic variant or are assigned in non-genotyping group receive the standard dose of thiopurines based on the conventional approach.
Patients in the non-genotyping group receive the standard dose of thiopurines based on the conventional approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-80 years old
- •Patients who were diagnosed as having IBD based on clinical, endoscopic, radiographic, and histological assessments,
- •Patients who were planned to start thiopurines for the first time for the treatment of IBD.
排除标准
- •Patients who had previous use of thiopurine
- •Those who had abnormal laboratory findings prior to screening, including white blood cell (WBC) count < 3,000/μL, platelet (PLT) count < 100/μL, or elevation of aminotransferase more than twice the upper normal limits
- •Those who were diagnosed other infectious diseases at the time of screening or receiving antibiotics within the previous 7 days;
- •Those who were pregnant or lactating.
研究组 & 干预措施
Genotyping group
The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO)
干预措施: genotyping for three genes (TPMT, NUDT15 and FTO) (Genetic)
Non-genotyping group
Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping.
干预措施: non-genotyping (Other)
结局指标
主要结局
Cumulative incidence of myelosuppression
时间窗: 1 year
次要结局
未报告次要终点