Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- All adverse effects throughout the protocol
研究概览
简要总结
The purpose of this study is to determine whether recombinant human hepatocyte growth factor is safe and effective in the treatment of fulminant and late-onset hepatic failure.
详细描述
Fulminant and late-onset hepatic failure (LOHF) is intractable disease with high degree of fatality (70-80%). Only liver transplantation is established as a therapeutic modality to rescue patients with fulminant hepatic failure or LOHF. However, approximately 75% of the patients are not able to receive liver transplantation in Japan, and effective non-surgical treatment has not been established yet. Hepatocyte growth factor (HGF) is one of major agents stimulating liver regeneration and ameliorating hepatic injury.
In this study, recombinant human HGF is administered to patients with fulminant hepatic failure or LOHF, who can not receive liver transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of fulminant or late-onset hepatic failure
- •Must be unable to receive liver transplantation
排除标准
- •Under 16 years old
- •Cancer patients
- •Pregnancy-aged women
- •Impaired renal function
- •Impaired cardiac function
- •Severe complications including pneumonia, sepsis, DIC and so on
结局指标
主要结局
All adverse effects throughout the protocol
次要结局
- Survival time at 4 weeks
- Degree of hepatic encephalopathy at 3, 5, 8, 11, 15, 21, and 28 days
- Liver function test at at 3, 5, 8, 11, 15, 21, and 28 days