The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Response
研究概览
简要总结
Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy
详细描述
The investigators are undertaking a parallel group, randomized controlled trial of adults with ITP in pregnancy in China. Patients were randomized to prednisone plus rhTPO and prednisone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout 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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational weeks ≥20 weeks;
- •Platelet count <30×10^9/L, accompanied with or without bleeding symptoms;
- •Confirmed diagnosed, treatment-naive ITP in pregnancy;
- •Willing and able to sign written informed consent.
排除标准
- •Secondary ITP such as drug-related thrombocytopenia;
- •Thrombocytopenia caused by viral infection (HIV, hepatitis B or hepatitis C); Other autoimmune diseases (including positive anti-nuclear antibodies, positive anti-cardiolipin antibodies, positive lupus anticoagulant factors, and positive Coombs) with severe heart, kidney, liver or respiratory dysfunction;
- •Severe immunodeficiency;
- •Myelodysplastic or myeloid fibrosis;
- •History of malignancy.
研究组 & 干预措施
Prednisone plus rhTPO
Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks
干预措施: Prednisone (Drug)
Prednisone plus rhTPO
Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks
干预措施: Recombinant Human TPO (Drug)
Prednisone
Prednisone 20mg per day, 2 weeks
干预措施: Prednisone (Drug)
结局指标
主要结局
Response
时间窗: day 14
Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Platelet counts at delivery
时间窗: At delivery
Platelet counts at delivery
次要结局
- Number of patients with bleeding(During treatment（up to 6 weeks after delivery）)
- Number of patients with adverse events(During treatment（up to 6 weeks after delivery）)
- Platelet counts of newborns(at delivery)
- Number of newborns with adverse events(During treatment（up to 6 weeks after delivery）)
- Loss of response(During treatment（up to 6 weeks after delivery）)
研究者
Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Peking University People's Hospital