NCT01162941Unknown2 期
Efficacy of Helicobacter Pylori Eradication, Anti-D and Danazol Combination in Steroid Dependant or Refractory Immune Thrombocytopenia (ITP)
Cooperative Study Group A for Hematology2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Proportion who would avoid splenectomy at 6 months of follow up
研究概览
简要总结
Proportion who would avoid splenectomy at 6 months of follow up
详细描述
- If urea breath test (+); omeprazole 20mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 1 week.
Second line Helicobacter pylori eradication will be permitted after failure of first line treatment. 2. Anti-D Anti-Ro 50 μg/kg IV for 2 days (D1, 2) 3. Danazol maintenance (from D1): Danazol will be continued at least 3 months. The dose of danazol can be reduced according to the adverse effects, especially in premenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.ITP is defined by
- •(a) a true thrombocytopenia on blood smear, (b) adequate megakaryopoiesis on bone marrow examination, (c) the absence of clinically apparent associated conditions or cause of thrombocytopenia
- •2.Steroid dependant ITP: more than 10 mg of prednisolone per day is required to maintain a platelet count above 20X109/L (minimum follow up duration: 3 months after diagnosis)
- •3.Steroid refractory ITP: a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
- •4.18 years old or more
排除标准
- •1.Patients who have a cause of thrombocytopenia such as HIV infection, lymphoproliferative disease, liver disease, definite SLE or drug
- •2.Pregnancy
- •3.Splectomized patients
- •4.Rh- blood type
- •5.Hemoglobin < 10g/dL
- •6.Known hypersensitivity to immunoglobulins
- •7.A positive direct antiglobulin test
- •8.Clinically relevant hepatic or renal disease
结局指标
主要结局
Proportion who would avoid splenectomy at 6 months of follow up
时间窗: 2years
Proportion who would avoid splenectomy at 6 months of follow up
次要结局
- SR,IR(2years)
研究者
研究点 (2)
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