Evaluating the Efficacy and Safety of the Combination of Herombopag and Human Thrombopoietin (rhTPO) in the Treatment of Patients With Severe Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
Severe immune thrombocytopenia (ITP) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. Some patients with severe ITP did not respond to first-line treatment including steroids and IVIG. It was critical for them to use effective treatments to promote platelet and reduce the risk of fatal bleeding. In this study, the patients with severe ITP will be treated with hetrombopag, rhTPO, and the combination of hetrombopag and rhTPO, respectively. The effect evaluation includes the increase of platelet number and decrease of bleeding scores. Changes of coagulation, platelet activation, fribrinolysis influence, and thrombotic events will also be accessed for the safety of treatments. The aim of this study is to demonstrate that the combination of hetrombopag and rhTPO for severe ITP is more effective than the other two monotherapy and does not increase thrombotic events or thrombosis risk.
详细描述
Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group. The effective rate of treatment, the rate and amplitude of platelet increase, the response time of platelet maintenance, and the effect of combination therapy on hemostasis will be compared. At the same time, the investigators will analyze the markers of thrombosis and thrombotic events to assess the safety of combination therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female,70 ≥age≥18；
- •Diagnosed as primary immune thrombocytopenia；
- •Platelet count was less than 10 × 10E9 / L with active bleeding, or bleeding score ≥ 5 points；
- •No use of IVIG, Avatrombopag, Eltrombopag or Romiplostim 2 weeks before treatment；
- •Rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks.
- •There was no history of platelet transfusion one week before treatment.
排除标准
- •Secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded；
- •Patients with active malignant tumors, pregnancy, severe cardiovascular， cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded；
- •Patients deemed unsuitable for enrollment by the investigator；
- •Patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease;
- •Patients reject to participate in the study.
研究组 & 干预措施
rhTPO
rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days.
干预措施: rhTPO (Drug)
Herombopag
Herombopag will be taken orally at 5 mg daily for 28 days.
干预措施: Herombopag (Drug)
Herombopag in combination of rhTPO
Herombopag will be taken orally at 5 mg daily for 28 days，while rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days
干预措施: rhTPO (Drug)
Herombopag in combination of rhTPO
Herombopag will be taken orally at 5 mg daily for 28 days，while rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days
干预措施: Herombopag (Drug)
结局指标
主要结局
Response Rate
时间窗: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
platelets ≥30\*10E9/L, and at least 2 times higher than the baseline platelet count, and there is no hemorrhagic manifestations
The rate and magnitude of the increase in platelet count
时间窗: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
The rate and magnitude of the increase in platelet count after treatment
Platelet maintenance response time
时间窗: From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Platelets stay above 30\*10E9/L
次要结局
- the markers of thrombosis and fibrinolysis(From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment)
- Platelet fuction(From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment)
- Thrombotic events(From randomization to 3 months after rhTPO/Herombopag/Herombopag+rhTPO treatment)
研究者
Yin Jie
Physician
The First Affiliated Hospital of Soochow University