NCT05522465招募中4 期
Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 608
- 试验地点
- 1
- 主要终点
- initial treatment response
研究概览
简要总结
Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)
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
- 29 Days 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects enrolled in this study must meet all of the following criteria:
- •Meet the ITP diagnostic criteria, within 3 months of the first diagnosis
- •Age > 28 days and ≤ 14 years old
- •Untreated PLT<20×109/L, or PLT<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment
- •Have signed the informed consent
排除标准
- •Anyone who has any of the following conditions will not enter the clinical study:
- •Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and thrombopoietic drugs (recombinant human thrombopoietin, eltrombopag, etc.)
- •Received glucocorticoid therapy within 6 months
- •Menstrual female children
- •Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
- •Patients who have received radiotherapy and chemotherapy
- •There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.)
- •There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results
研究组 & 干预措施
prednisone group
Experimental
prednisone 4mg/kg.d
干预措施: Prednisone (Drug)
Dexamethasone
Active Comparator
Dexamethasone 0.6mg/kg.d
干预措施: Dexamethasone (Drug)
结局指标
主要结局
initial treatment response
时间窗: 30 days after treatment
Platelet count after glucocorticoid therapy 1 month
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](1 month)
研究者
研究点 (1)
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