Safety, Tolerability and Efficacy Study of a Caspase Inhibitor, IDN-6556, in Patients Undergoing Orthotopic Liver Transplantation (OLT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 13
- 主要终点
- Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
研究概览
简要总结
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
详细描述
The occurrence of apoptosis in liver ischemia/reperfusion injury has been well characterized in animal models. In this context apoptosis has specifically been observed in sinusoidal endothelial cells and hepatocytes, and this has also been associated with an increase in activated caspase-3 in liver tissue extracts. The use of caspase inhibitors to prevent apoptosis during liver storage and transplantation may reduce ischemia/reperfusion injury and hence improve graft function after transplantation. Suppression of apoptosis by caspase inhibitors may also allow for longer ischemic times allowing organs to be transported greater distances. In addition, suppression of apoptosis may lower the risk involved in using suboptimal donor organs.
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
- Double
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
- •Minimum adult age
排除标准
- •Fulminant hepatic failure (UNOS Status I patients)
- •Previous liver transplantation
- •Patients undergoing split liver grafts
- •Extrahepatic malignancy
- •If female, pregnant or lactating
研究组 & 干预措施
Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo
干预措施: Placebo (Drug)
Donor organ placebo and Recipient placebo
干预措施: Placebo (Drug)
Donor organ: IDN-6556 (15μg/ml), Recipient: Placebo
干预措施: IDN-6556 (Drug)
Donor organ: IDN-6556 (5 μg/ml), Recipient: IDN-6556 0.5 mg/kg
干预措施: IDN-6556 (Drug)
Donor organ: IDN-6556(15 μg/ml), Recipient: IDN-6556 0.5 mg/kg
干预措施: IDN-6556 (Drug)
结局指标
主要结局
Peak absolute change in alanine aminotransferase (ALT) values measured from baseline to up to 3 days post-transplantation
Peak absolute change in aspartate transaminase (AST) values measured from baseline to up to 3 days post-transplantation
次要结局
未报告次要终点