Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Response
研究概览
简要总结
This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.
详细描述
The investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive ITP. A total of 100 participants are randomized to two groups with the 1:1 ratio: prednisone plus IVIg group versus prednisone monotherapy group. Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mg/Kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Time to response and platelet counts of newborns are investigated. Adverse events including participants and their newborns are also recorded throughout and after the study.
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
- 否
入选标准
- •Age 18-50 years old;
- •Meet the diagnostic criteria for immune thrombocytopenia;
- •Pregnant women with ITP without ITP-specific treatments during pregnancy;
- •Gestational weeks ≥12 weeks;
- •Platelet count <30×10^9/L, accompanied with or without bleeding symptoms.
- •Willing and able to sign written informed consent.
排除标准
- •Have a known diagnosis of other autoimmune diseases, confirmed medical history or laboratory findings within positive anti-nuclear antibodies (>1:80), anti-cardiolipin antibodies, lupus anticoagulant factors or direct Coombs' test.
- •Thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver of pregnancy.
- •Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on.
- •With other underlying diseases that may cause thrombocytopenia, such as: malignant disease, megaloblastic anemia, aplastic anemia, myelodysplasia syndrome, myeloid fibrosis, disseminated intravascular coagulation, thrombotic thrombocytopenic purpura, Hemolytic uremic syndrome, disseminated intravascular coagulation and so on;
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- •With severe heart, kidney, liver or respiratory dysfunction;
- •With the medical history of mental illness;
- •Have allergic reaction to prednisone or IVIg;
研究组 & 干预措施
The combination group
Prednisone 20mg per day×4 weeks and IVIg 400mg/kg per day（≤20g per day）×5 days
干预措施: Prednisone (Drug)
The combination group
Prednisone 20mg per day×4 weeks and IVIg 400mg/kg per day（≤20g per day）×5 days
干预措施: IVIg (Drug)
The prednisone group
Prednisone 20mg per day×4 weeks
干预措施: Prednisone (Drug)
结局指标
主要结局
Overall Response
时间窗: 4 weeks
Achieving a platelet count of≥30×10\^9/L and at least a doubling of the baseline platelet count without administration of any other ITP-specific treatment, and the absence of bleeding
次要结局
- Complete Response(4 weeks)
- Time to relapse (duration of efficacy)(1 year)
- relapse(1 year)
- Time to Response(4 weeks)
- Early response(1 week)
- Platelet counts at delivery(At delivery)
- Platelet counts of newborns(up to 42 days per newborn)
- Adverse events in parturients(2 years)
研究者
Xiao Hui Zhang
Vice President of Peking University Institute of Hematology
Peking University People's Hospital