Therapeutic Effects and Safety of RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of Hepatitis b Virus Related Acute-on-chronic Liver Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with Hepatitis b virus related acute-on-chronic liver failure.
详细描述
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. But there still lacks of effective therapies in treatment of HBV related ACLF, except liver transplantation. RL-1 Novel Human-derived Bio-artificial Liver treatment may be an effective and safe therapy due to the previous clinical data. This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with HBV related ACLF.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- •Age from 18 to 65 years old;
- •Serum total bilirubin level > 10 times upper limit of normal;
- •Prothrombin time activity < 40% and ≥30%；
- •Platelets > 50*10 E9/L.
排除标准
- •Other active liver diseases;
- •Hepatocellular carcinoma or other malignancy;
- •Pregnancy or lactation;
- •Human immunodeficiency virus infection or congenital immune deficiency diseases;
- •Severe diabetes, autoimmune diseases;
- •Other important organ dysfunctions;
- •Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
- •Patients can not follow-up;
- •Investigator considering inappropriate.
结局指标
主要结局
Adverse events
时间窗: 4 week
All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.
次要结局
- Symptoms(4 week)
- Survival rate(4 week)
- Prothrombin time(4 week)
- Alanine transaminase(4 week)
- Total bilirubin(4 week)
- Blood ammonia(4 week)
- Serum creatinine(4 week)
- Blood cells(4 week)
研究者
Liang Peng
Professer
Third Affiliated Hospital, Sun Yat-Sen University