A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary endpoint: The development of histologically proven acute rejection. (within 12 months
研究概览
简要总结
Objective:
The overall objective is to investigate whether a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation and whether it promotes tolerance.
详细描述
3.2 Research question
Is it possible to avoid the use of corticosteroids in pediatric liver transplantation?
3.3 Trial objectives
This will be a pilot study to
i) investigate to what degree a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children undergoing primary isolated hepatic transplantation.
- •Age <=18 years
- •Ability to provide informed consent
排除标准
- •Children undergoing retransplantation.
- •Transplantation for Intestinal failure associated liver disease.
- •Multi-organ transplantation.
- •Transplantation for autoimmune liver disease.
- •Transplantation for extra hepatic malignancy.
- •Pre-existing need for oral steroids, or high dose inhaled steroids sufficient to require a steroid warning card.
研究组 & 干预措施
Steroid immunosuppressive regimen
Freedom from rejection and safety in children undergoing paediatric liver transplant using steroid containing immunosuppression regimen post transplant. This group of patients will receive steroids in conjunction with other prescribed immunosuppressive agents. Intervention is use of methyl prednisolone, hydrocortisone, prednisolone as routine post transplant management
干预措施: methyl prednisolone, hydrocortisone, prednisolone (Drug)
Steroid free immunosuppressive regimen
Freedom from rejection and safety in children undergoing paediatric liver transplant using steroid free immunosuppression regimen post transplant. The patients in this arm will receive immunosuppression but not steroids to compare with those treated with steroids to measure differences in rejection and safety of a steroid free immunosuppressive regimen. Intervention is omission of methyl prednisolone, hydrocortisone, prednisolone as routine post transplant management. No steroids will be used routinely in this arm
干预措施: No steroids (Other)
结局指标
主要结局
Primary endpoint: The development of histologically proven acute rejection. (within 12 months
时间窗: 12m
次要结局
- The development of steroid resistant acute rejection 12 months. The expression of tissue and circulating markers of immune tolerance in first year post transplant The incidence of infection in the first year post transplant(12m)