Phase 2 Evaluation of the Vitagen Extracorporeal Liver Assist Device (ELAD) System in the Management of the Patients With Fulminant Hepatic Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 7
- 主要终点
- Number of subjects reaching 30-Day survival
研究概览
简要总结
The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.
详细描述
Current treatment with modalities in Acute Liver Failure still carry unacceptable morbidity and mortality. It is hoped that by intervening with ELAD a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Fulminant Hepatic Failure with encephalopathy, and coagulopathy
- •Weight not less than 40 kilograms
- •Not listed for organ transplant, but no medical contraindications for transplant
排除标准
- •Listed for organ transplant at stud entry
- •History of jaundice for greater than 28 days at screening
- •Liver dysfunction due to trauma
- •Concomitant serious disease
研究组 & 干预措施
Standard of care (Control)
Standard of care for patients with fulminant hepatic (liver) failure
干预措施: Standard of care (Control) (Other)
ELAD
Treatment with ELAD, extracorporeal liver assist system and standard of care
干预措施: ELAD (Biological)
结局指标
主要结局
Number of subjects reaching 30-Day survival
时间窗: Study Day 30
30-day survival
次要结局
- 30-day transplant-free survival(Study Day 30)