A Multicenter Clinical Study of Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia
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
- Platelet count during delivery
研究概览
简要总结
The purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO in the treatment of pregnancy-induced thrombocytopenia.
详细描述
The project is undertaken by Qilu Hospital of Shandong University and other 6 well-known hospitals in China. The investigators anticipate to undertaking a concurrent control, multicentre trial including 60 pregnancy associated ITP adult patients which are ineffective for first-line treatment or platelets infusion and 30 healthy pregnancy control. 30 of the ITP patients are selected to receive rhTPO(given different dose according to the platelet count, the risk of bleeding and delivery), the other ITP patients are selected not to receive rhTPO. Platelet count, bleeding and other symptoms of ITP patients and their newborns are evaluated after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the rhTPO for the treatment of pregnancy with ITP.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Meet the diagnostic criteria for immune thrombocytopenia.
- •18-50 years of age; gestational age over 32 weeks;
- •No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted);
- •Platelet transfusion was not effective.
- •Platlet count of the patients <30* 10^9/L and had the risk of bleeding or bleeding.
- •No obvious abnormalities in liver and kidney function had (1.5 times higher than normal limit of the serum urea nitrogen, creatinine, serum transaminase and bilirubin );
- •No severe cardiac and pulmonary dysfunction;
- •No history of mental illness;
- •Voluntarily signed written informed consent.
排除标准
- •A history of serious allergies to biologics;
- •The history of thrombosis;
- •Thromboembolic or hemorrhagic disease;
- •Patients who are deemed unsuitable for the study by the investigator.
研究组 & 干预措施
experimental group
Accepting the treatment of rhTPO according platelet and bleeding condition
干预措施: recombinant human thrombopoietin (Drug)
non-administered group
No rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions.
干预措施: Platelet Concentrate (Drug)
结局指标
主要结局
Platelet count during delivery
时间窗: up to 2 years per subject
Platelet count during delivery will be assessed
次要结局
- Adverse events in neonates(up to 2 years per subject)
- platlet count of newborns(up to 42 days per newborn)
- Adverse events in parturients(up to 2 years per subject)
研究者
Ming Hou
Professor and Director
Shandong University