Thrombocytopenia in Gestational Period
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 主要终点
- Response rate (CR+R)
研究概览
简要总结
The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.
详细描述
The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given dexamethasone intravenously at a dose of 40mg every day for four days. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is between 20-50 years old.
- •After 12 weeks gestation.
- •Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
- •Patients who have no response or relapsed after Corticosteroid or IVIG.
- •Patients developed refractoriness to platelet transfusion.
- •To show a platelet count < 30×10^9/L, and with bleeding manifestations.
- •Willing and able to sign written informed consent.
排除标准
- •Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- •Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- •Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.
- •Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).
- •Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- •Patients who are deemed unsuitable for the study by the investigator.
研究组 & 干预措施
dexamethasone
dexamethasone 40mg/d for 4 days
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Response rate (CR+R)
时间窗: 3 months
次要结局
- Adverse events(2 years)
- live birth rate(2 years)
- Platelet count(2 years)