Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of allograft liver fibrosis
研究概览
简要总结
This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.
详细描述
Tacrolimus is a commonly used immunosuppressant after liver transplantation. However, with increased postoperative time and a decline in postoperative compliance, some children may miss medication, leading to acute rejection. Repeated rejection can cause fibrosis of the transplanted liver, seriously impacting graft function and even postoperative survival, sometimes resulting in the need for a second liver transplant. In adult liver transplant recipients, tacrolimus sustained-release capsules have been shown to significantly improve overall and transplanted liver survival compared to conventional formulations (immediate-release tacrolimus，taken twice daily). Therefore, this study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;
- •Able to completely swallow capsules;
- •Have been using immediate-release tacrolimus for at least three months prior to study enrollment;
- •Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;
- •Undergo a programmed liver biopsy;
排除标准
- •Multi-organ combined transplantation or multiple liver transplantation;
- •Adjuvant liver transplantation or use of bioartificial liver therapy;
- •ABO incompatible children with liver transplantation;
- •Allergic to tacrolimus;
- •Participation in any other clinical study within 3 months prior to enrollment;
- •Use of tacrolimus sustained release capsules before enrollment;
- •Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;
研究组 & 干预措施
Prolonged-release tacrolimus
干预措施: Tacrolimus Sustained-release Capsules (Drug)
结局指标
主要结局
Incidence of allograft liver fibrosis
时间窗: 12 months
allograft liver fibrosis would be evaluated by LAFSc
Incidence of biopsy-confirmed acute rejection (BPAR)
时间窗: 12 months
biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification
次要结局
- Incidence of infection(12 months)
- Liver allograft survival rate(12 months)
- Kidney function(12 months)
- Liver function(12 months)
- The rate of drug change(12 months)