NCT05520892招募中4 期
A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children
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
- 580
- 试验地点
- 1
- 主要终点
- early response to treatment
研究概览
简要总结
To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate
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 diagnostic criteria of ITP and be diagnosed for the first time without treatment
- •Age > 28 days and ≤ 14 years old
- •PLT<20×109/L
- •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 glucocorticoid therapy
- •Received glucocorticoid or IVIG therapy within 6 months
- •Weight > 40kg
- •Menstrual female patients
- •Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
- •Patients who have received radiotherapy and chemotherapy
- •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
low-dose intravenous immunoglobulin
Experimental
0.4g/kg.d, d1-5
干预措施: intravenous immunoglobulin (Drug)
high-dose intravenous immunoglobulin
Active Comparator
1.0g/kg.d, d1-2
干预措施: intravenous immunoglobulin (Drug)
结局指标
主要结局
early response to treatment
时间窗: 7 days after treatment
Platelet counts after 7 days of IVIG treatment
次要结局
- Economic Indicators(1 week)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](1 week)
研究者
研究点 (1)
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