A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- response rate and platelet count
研究概览
简要总结
To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.
详细描述
Patients will be randomized to one of two study arms:
dexamethasone 40 mg po daily for 4 consecutive days. If the platelet count drops below 30X109/L after response within 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering (Arm 1).
Prednisone 1 mg/kg po daily for 4-8 weeks, the drug is then decreased slowly over another few weeks (Arm 2).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a true thrombocytopenia on blood smear
- •adequate megakaryopoiesis on bone marrow examination
- •the absence of clinically apparent associated conditions or cause of thrombocytopenia
- •Age over 16 years
- •A platelet count of less than 30x109/L
排除标准
- •previous treatment for ITP.
- •other causes of thrombocytopenia such as HIV infection, lymphproliferative disease, liver disease, or definite SLE.
- •Patients with life threatening bleeding and pregnant women should be excluded.
结局指标
主要结局
response rate and platelet count
时间窗: 6 years
Endpoint definitions and criteria for evaluation: This study is designed to compare the effectiveness of high dose dexamethasone with conventional dose prednisone for patient with ITP. The effectiveness will be evaluated in terms of response rate and platelet count at 6 months after the treatment
次要结局
未报告次要终点