Granulocyte Colony-stimulating Factor(G-CSF) in the Treatment of Hepatic Failure: a Prospective Randomized Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Survival rates
研究概览
简要总结
This study evaluates the Granulocyte colony-stimulating factor (G-CSF) in the treatment of Acute on Chronic Liver Failure in adult. Half participants will receive G-CSF and standard treatment in combination, while half participants will receive standard treatment.
详细描述
Granulocyte colony-stimulating factor (G-CSF) can be used to mobilize stem cells to the periphery and the liver tissue in patients with advanced liver disease, and could promote hepatic regeneration. Moreover, G-CSF was reported to protect patients from sepsis by restoring the function of both neutrophils and monocytes. Therefore, G-CSF therapy may be beneficial for liver regeneration in patients with ACLF induced by different causes.
standard therapy for the treatment of ACLF includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. HBV associated ACLF patients receive entecavir at the same time
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
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 17ys to 70ys;
- •fale or femal;
- •ACLF, as defined by the Asian Pacific Association for the Study of the Liver Working Party, is an acute hepatic insult manifested as jaundice (serum bilirubin ≥ 5 mg/dL) and coagulopathy[international normalized ratio (INR) ≥ 1.5 or prothrombin activity< 40%], with complications of ascites and/or encephalopathy within 4 wk in patients previously diagnosed or undiagnosed with chronic HBV associated liver disease and alcoholic liver
排除标准
- •super-infection or co-infection with hepatitis A, C, D, E,Epstein-Barr virus, cytomegalovirus, or human immunodeficiency virus;
- •a previous course immuno-modulator or cytotoxic/immunosuppressive therapy for chronic hepatitis within the prior 12 mo;
- •hepato-cellular carcinoma diagnosed by computed tomography or magnetic resonance imaging;
- •co-existence of any other serious medical illnesses or other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;
- •any concurrent evidence of sepsis;
- •malignant jaundice induced by obstructive jaundice and hemolytic jaundice;
- •prolonged prothrombin time due to blood system disease.
研究组 & 干预措施
Granulocyte colony-stimulating factor
Granulocyte colony-stimulating factor(G-CSF) was given 5 ug/kg subcutaneously qd for 6 doses,then qod for other 6 doses(total 12 doses).
Standard treatment includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. HBV associated ACLF patients receive entecavir at the same time
干预措施: Granulocyte colony-stimulating factor (Drug)
Granulocyte colony-stimulating factor
Granulocyte colony-stimulating factor(G-CSF) was given 5 ug/kg subcutaneously qd for 6 doses,then qod for other 6 doses(total 12 doses).
Standard treatment includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. HBV associated ACLF patients receive entecavir at the same time
干预措施: standard treatment (Drug)
standard treatment
Standard treatment alone
干预措施: standard treatment (Drug)
结局指标
主要结局
Survival rates
时间窗: 12 weeks
次要结局
- (Model of End Liver Disease,MELD) score(at 4 weeks; and at 12 weeks)
- (Sepsis-related Organ Failure Assessment,SOFA) score(at 4 weeks; and at 12 weeks)
- incidence of complications;including infection, HRS(at 4 weeks; and at 12 weeks)
- Total Bilirubin,TbiL(at 4 weeks; and at 12 weeks)
研究者
Jinhua Hu
Prof. & Chief Physician
Beijing 302 Hospital