Extension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic Anemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The ratio of subjects with clonal evolution at 6 months and 18 months
研究概览
简要总结
This is a multicenter, placebo-control, phase 3 study of hetrombopag in patients with treatment-naive severe aplastic anemia. All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.
Subjects will receive the same study drug (hetrombopag or placebo) as in study HR-TPO-SAA-III, with the same doses and administration schedule or with modifications based on the actual conditions.
The primary objective of this extension study is to give the subjects participating in the HR-TPO-SAA-III study the continued access to the study drug (hetrombopag or placebo) after the completion of the HR-TPO-SAA-III study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed or withdrawn from the HR-TPO-SAA-III study
- •Subjects who have signed the informed consent form
- •Female and male subjects of childbearing age who agree to take adequate contraceptive measures during the extension study period and within 28 days after the last dose
- •Subjects who have completed the end-of-treatment evaluation in the original study
排除标准
- •Any unstable situation or situation that will compromise the safety of the subject
- •Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of the HR-TPO-SAA-III study
- •Subjects with uncontrollable hemorrhage and/or infection after standard treatment
- •Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke, or peripheral arterial embolism within 1 year
- •Any situation that may compromise the subject and the safety or compliance thereof during the study
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Hetrombopag Olamine
干预措施: Hetrombopag Olamine (Drug)
结局指标
主要结局
The ratio of subjects with clonal evolution at 6 months and 18 months
时间窗: 6 months and 18 months
All AEs resulting in discontinuation and withdrawal from study
时间窗: 3 years
All SAEs, regardless of whether they are related to the investigational product
时间窗: 3 years
All SIEs, regardless of whether they are related to the investigational product
时间窗: 3 years
次要结局
- Hemoglobin(by 1day visit)
- Platelet count(by 1day visit)
- Red blood cell count(by 1day visit)
- White blood cell count(by 1day visit)
- Neutrophil count(by 1day visit)
- Reticulocyte count(by 1day visit)
- The 6-month and 18-month survival rates of subjects(6 months and 18 months)
- The recurrence rates at 6 months and 18 months(6 months and 18 months)