Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Tolerability of Fenofibrate
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of a once-daily medication, fenofibrate (Lofibra), to prevent ischemic cholangiography (IC) in persons who were transplanted with livers donated after circulatory death (DCD).
详细描述
In this prospective pilot study, we aim to evaluate 1) the tolerability and safety, 2) the efficacy of 12 weeks once-daily fenofibrate in reducing IC incidence after DCD liver transplantation, 3) assess the association between serum markers of cholestasis and development of IC.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone Donation after Circulatory Death (DCD) liver transplantation (LT).
- •At least one serum alkaline phosphatase level >2.5x upper limit of normal between post-LT days 21-60 (inclusive).
- •Exclusion criteria:
- •LT performed for primary sclerosing cholangitis or primary biliary cholangitis.
- •Untreated hepatic artery compromise (e.g thrombosis, stenosis)
- •Untreated biliary anastomotic stricture or bile leak between days 0-60 after LT
- •Renal dysfunction defined as baseline glomerular filtration rate < 30 ml/min.
- •Previously known intolerance or allergy to fenofibrate.
- •Other clinically significant comorbid condition, including psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment.
- •Adults lacking capacity to consent to treatment
排除标准
- 未提供
研究组 & 干预措施
Recipients of DCD liver transplants
Subjects that have undergone transplant of a liver donation after circulatory death (DCD) in the last 21-35 days will receive a 12 week fenofibrate (Lofibra) for a duration of 12 weeks
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Tolerability of Fenofibrate
时间窗: 12 weeks
Proportion of subjects to discontinue fenofibrate due to adverse events
次要结局
- Safety of Fenofibrate(16 weeks)
- Efficacy of Fenofibrate(12 weeks)
- The Number of Participants Who Developed Ischemic Cholangiopathy (IC)(12 weeks)
研究者
Channa R Jayasekera, MD, MSc
Principal Investigator
Mayo Clinic