Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The proportion of patients who require blood product infusion or intervention with platelet raising drugs due to bleeding during the perioperative period
研究概览
简要总结
This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.
详细描述
The purpose of this study is to assess the ability of Herombopag to elevate platelet counts thereby reducing the need for platelet transfusions in patients with thrombocytopenia before hepatectomy. The clinical benefit of Herombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an hepatectomy. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events will be monitored during this time and for up to 3 months after undergoing a hepatectomy to help further evaluate clinical benefit.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ≥18 years of age；
- •2.Patients prepared to receive hepatectomy；
- •3.50×10^9/L≤platelet count≤80×10^9/L；
- •4.Child-PUgh score A or grade B (≤7 )；
- •5.Life expectancy ≥3 months；
- •6.Normal Bone marrow hematopoiesis and renal function;
- •7.Voluntary participation and written informed consent;
排除标准
- •1.Central nervous system diseases caused by liver disease;
- •2.Platelet transfusion within 7 days prior to the first dose of study drug;
- •3.History of any primary hematologic disorder;
- •4.History of arterial or venous thrombosis, including thrombosis of any part of the splenic-mesenteric system;
- •5.Pre-diagnosed Immune Thrombocytopenic Purpura (ITP);
- •6.History of Myelodysplastic Syndrome (MDS);
- •7.Those with bleeding tendency，have evidence of hereditary bleeding or blood coagulation disorder;
- •8.Females who are pregnant (positive β-hCG test ) or breastfeeding;
- •9.Subjects who have participated in another investigational trial within 30 days prior to Visit 1;
- •10.Those with uncontrollable neurological and psychiatric diseases or mental disorders, poor compliance, unable to cooperate and describe treatment response;
- •11.Subjects with known intolerance or allergy to any of the ingredients in eltrombopag tablets;
研究组 & 干预措施
Experimental: 1
durg：Hetrombopag 5mg，once daily，oral
干预措施: Hetrombopag (Drug)
Experimental: 2
Ndurg： Placebo 5mg，once daily，oral
干预措施: Placebo (Drug)
结局指标
主要结局
The proportion of patients who require blood product infusion or intervention with platelet raising drugs due to bleeding during the perioperative period
时间窗: From the start of using the investigational drug to 7 days after surgery completion
Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.
次要结局
- Incidence of deep venous thrombosis(up to 3 months following surgery.)
- Proportion of patients with bleeding after surgery need intervention.(up to 7 days following surgery。)
- Proportion of patients whose Platelet count returned to ≥80×10^9/L(baseline and up to 1 days prior to surgery)
- Changes in preoperative Platelet count compared to baseline(baseline and up to 1 days prior to surgery)
- Incidence of liver failure(up to 3 months following surgery.)
研究者
Lu Wang, MD, PhD
Chief physician
Fudan University