NCT02820259已完成不适用
Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)
Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC
研究概览
简要总结
The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (> 18 years) of both sexes,
- •Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,
- •Not having expressed their opposition to participation in the study
排除标准
- •Bilio-enteric anastomosis,
- •Associated transplantation of another organ
- •Contraindications to TCR administration
- •Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.
结局指标
主要结局
coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC
时间窗: during the first 7 days after its initiation
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant RecipientsBlood Concentration of Tacrolimus MetabolitesNCT05277792Rennes University Hospital48
已完成
4 期
A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant PatientsKidney TransplantationLiver TransplantationNCT03465969Astellas Pharma Europe Ltd.80
已完成
不适用
Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT RecipientsGraft Vs Host DiseaseTransplant FailureStem Cell Transplant ComplicationsNCT06080490University of Pisa125
已完成
不适用
Tacrolimus in CD3+ T LymphocytesImmunosuppressionNCT06342505Erasmus Medical Center28
已完成
2 期
Distribution of Tacrolimus in Skin, Atopic DermatitisDermatitis, AtopicNCT00534508Astellas Pharma Inc14