ACTRN12623000340639招募中3 期
Budesonide versus prednisolone after liver transplantation: a phase 3, open label, non-inferiority randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •All adult (age 18 years or over) patients accepted for liver transplantation at Austin Health.
排除标准
- •- Strong medical rationale for a corticosteroid-free protocol (e.g. severe psychiatric comorbidities, high risk of infection) as determined by the Liver Transplant Multidisciplinary Team
- •- Patient with autoimmune hepatitis
- •- Corticosteroid dependency prior to trial enrolment
- •- Patients receiving multi-visceral organ transplantation
- •- Previous liver transplant recipient requiring redo liver transplant
- •- Portosystemic shunt >15mm in diameter on imaging which will reduce budesonide first pass metabolism
- •- Concurrent use of medications that are significant cytochrome P450 3A4 inhibitors (e.g. erythromycin, clarithromycin, verapamil, diltiazem) which will reduce budesonide first pass metabolism
- •- Unable to take medications enterally (either orally or through tube feeding) by day 3 post liver transplant
- •- Patients unable to understand written English sufficiently to read PICF or have no carer to assist them with adequate understanding of PICF
研究者
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