The Efficacy and Safety of Herombopag in Treating Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery - A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Part A: Vc/F
研究概览
简要总结
This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Males or females aged 18 years or older withc a Child-Pugh score of Class A or Class B;
- •Platelet count less than 50×10^9/L on baseline;
- •Elective invasive procedures or surgeries that are planned.
排除标准
- •Any history of arterial or venous thrombosis, including partial or complete thrombosis;
- •Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening;
- •Portal vein blood flow velocity rate <10 centimeters/second at Screening;
- •There are other diseases that may cause thrombocytopenia.
研究组 & 干预措施
Treatment group 1
干预措施: Herombopag placebo tablets (Drug)
Treatment group 2
干预措施: Herombopag tablets (Drug)
Treatment group 1
干预措施: Herombopag tablets (Drug)
Treatment group 2
干预措施: Herombopag placebo tablets (Drug)
结局指标
主要结局
Part A: Vc/F
时间窗: 0 minute to 5 days
Part A: Kin
时间窗: 0 minute to 35 days
Part A: Kdeg
时间窗: 0 minute to 35 days
Part A: CL/F
时间窗: 0 minute to 5 days
Part A: ka
时间窗: 0 minute to 5 days
Part A: Q/F
时间窗: 0 minute to 5 days
Part A: AUC0-tau
时间窗: 0 minute to 5 days
Part A: Cmax
时间窗: 0 minute to 5 days
Part A: Kout
时间窗: 0 minute to 35 days
Part A: Slope
时间窗: 0 minute to 35 days
The proportion of subjects whose platelet count is ≥50×10^9/L within 24 hours before surgery and has increased by ≥20×10^9/L from baseline, and who have not received platelet transfusion or other treatments to raise platelet levels before surgery
时间窗: 0 minute to 11 days
Part B
次要结局
- The proportion of subjects with a platelet count of ≥50×10^9/L within 24 hours before surgery(0 minute to 11 days)
- The duration of time during the study when the platelet count remains ≥50×10^9/L(0 minute to 35 days)