Efficacy and Safety of Avatrombopag for Treating Thrombocytopenia in Hepatitis b Virus Related Acute-on-chronic Liver Failure Patients Receiving Artificial Liver Support System Treatment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of platelet ≥50*10E9/L
研究概览
简要总结
This study aims to investigate the efficacy and safety of avatrombopag for treating thrombocytopenia in hepatitis b virus related acute-on-chronic liver failure patients receiving artificial liver support system treatment.
详细描述
Artificial liver support system (ALSS) is an optimal therapy in patients with hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF). But a lot of patients encount thrombocytopenia (TCP) due to the mechanical damage of thrombocyte and use of heparin during the treatment. Avatrombopag is an oral thrombopoietin receptor agonist that has been recently approved for treating TCP in chronic liver disease patients needing invasive procedures. Therefore, this study aims to investigate the efficacy and safety of avatrombopag for treating TCP in HBV related ACLF patients receiving ALSS treatment. Sixty patients with HBV related ACLF receiving ALSS will be enrolled in this study. The participants are divided into trial group (avatrombopag, double plasma molecular adsorption system (DPMAS) , low volume plasma exchange (LPE), and comprehensive internal medical treatment) and control group (DPMAS, LPE, comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age from 18 to 65 years old;
- •Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA > 0.5 year);
- •Clinical diagnosis of liver failure (serum total bilirubin level > 10 times upper limit of normal; prothrombin time activity < 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and > 1.5);
- •Platelets < 80*10 E9/L and > 50*10 E9/L.
- •Signed informed consent form.
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; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
- •Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
- •Patients with ALSS treatment in one week;
- •Thrombotic disease;
- •Patients can not follow-up;
- •Investigator considering inappropriate.
研究组 & 干预措施
Trial Group
30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.
干预措施: Avatrombopag (Drug)
Trial Group
30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.
干预措施: Artificial Liver Support System (Other)
Trial Group
30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.
干预措施: Comprehensive internal medical treatment. (Other)
Control Group
30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
干预措施: Artificial Liver Support System (Other)
Control Group
30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
干预措施: Comprehensive internal medical treatment. (Other)
结局指标
主要结局
Rate of platelet ≥50*10E9/L
时间窗: 3 weeks
Rate of patients with platelet ≥50\*10E9/L during ALSS treatment
次要结局
- Rate of bleeding(3 weeks)
研究者
Liang Peng
Professor
Third Affiliated Hospital, Sun Yat-Sen University