The Efficacy and Safety of Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia: A Multicenter, Prospective, Randomized Controlled Trial（EAST）
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Platelet count response time
研究概览
简要总结
End stage liver disease is prone to thrombocytopenia. This study is a multi-center, randomized, prospective, randomized controlled Phase IV Clinical trial to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia.
详细描述
End stage liver disease is prone to thrombocytopenia. This study aims to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia in a multicenter, prospective, randomized controlled trial. The patients were divided into one of the groups according to if receiving avatrombopag. Avatrombopag was taken to maintain platelet count 50~100×10^9/L. Starting dose is recommended according to the patient's baseline platelet count level. Routine treatment was taken in the Control group and Interventional group. This trial will take about 2 to 2.5 years from the first participant signing an informed consent form (ICF) until all study-related telephone follow-ups or visits end.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women greater than or equal to 18 years of age;
- •Baseline platelet count <50×10^9/L;
- •End-stage liver disease, including acute-on-chronic liver failure, acute decompensation of liver cirrhosis, chronic liver failure;
- •Women of childbearing potential must agree to use a highly effective method of contraception from the beginning of Baseline Visit until the end of treatment (includes implantable contraception, injectable contraception, hormonal combination contraception [including vaginal rings], intra-uterine devices or vasectomy). The barrier contraception with or without spermicide alone, double barrier contraception and oral contraceptives are inadequate;
- •Subject is able to understand the study and willing to follow the protocol and sign informed consent voluntarily before Baseline Visit;
- •Subject meet the criteria according to the opinion of the researchers.
排除标准
- •Subject has a history of arterial or venous thrombosis within the previous 6 months of baseline;
- •Known portal vein blood flow velocity rate <10 cm/second or previous occurrence of a portal vein thrombosis within 6 months of Baseline;
- •Known any history of primary blood (e.g, immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
- •Subject has a known medical history of genetic prothrombotic syndromes (e.g, Factor V Leiden prothrombin G20210A, antithrombin III (AT III) deficiency);
- •Subject has a recent history (within the previous 6 months) of significant cardiovascular diseases (e.g., exacerbation of congestive heart failure, arrhythmias known to increase the risk of thromboembolic events [e.g. atrial fibrillation], coronary or peripheral artery stent placement or angioplasty, and coronary or peripheral artery bypass grafting);
- •Female subjects who are lactating or pregnant at the Baseline Visit (as documented by a positive serum beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG) or are planning to become pregnant during the study;
- •The subject has a hypersensitivity to Avatrombopag or any of its excipients;
- •Subjects with drug-induced thrombocytopenia;
- •Subjects whose Life expectation ≤6 months;
- •Subject with a current malignancy;
- •Subjects with HIV infection;
- •At screening, active infection was not effectively controlled by systemic antibiotic therapy;
- •The Investigator believe that any accompanying medical history may affect the safety of the subjects to complete the study;
- •The Investigator believe that there are any other factors that are not suitable for inclusion or affect participation or completion of the study;
- •Subject is enrolled in another clinical study with any investigational drug or device within previous 30 days of the Baseline Visit, but are allowed to participate in observational studies.
研究组 & 干预措施
Intervention group
Avatrombopag+Standard medical treatment
干预措施: Avatrombopag (Drug)
Intervention group
Avatrombopag+Standard medical treatment
干预措施: Standard medical treatment (Drug)
Control group
Standard medical treatment
干预措施: Standard medical treatment (Drug)
结局指标
主要结局
Platelet count response time
时间窗: 24 weeks
Platelet count response time(PLT) refers to condition of PLT during 24 weeks between the Intervention group and Control group.
次要结局
- Patients without platelet transfusion or rescue due to bleeding(24 weeks)
- Adverse Event (thrombotic events, bleeding events, etc.) incidence;(24 weeks)
- Incidence of complications of liver cirrhosis (infection, etc.)(24 weeks)
- Proportion of patients readmitted(24 weeks)
- Changes in total bilirubin level(24 weeks)
- Changes in alanine aminotransferase level(24 weeks)
- Changes in albumin level(24 weeks)
- Changes in prothrombin time level(24 weeks)
- Changes in international normalized ratio level(24 weeks)
研究者
Qin Ning
Director of Department of Infectious Diseases
Tongji Hospital