Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children

Study Overview
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Brief Summary
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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

Official Title
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A Multicenter, Randomized Controlled Study of Two Regimens of Intravenous Immune Globulin in the Treatment of Newly Diagnosed Immune Thrombocytopenia in Children

Conditions
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Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment

Intervention / Treatment
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* Drug: intravenous immunoglobulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: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 Exclusion Criteria: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 -

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dose intravenous immunoglobulin<br>0.4g/kg.d, d1-5 | Drug: intravenous immunoglobulin<br>* To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia<br>|
| Active Comparator: high-dose intravenous immunoglobulin<br>1.0g/kg.d, d1-2 | Drug: intravenous immunoglobulin<br>* To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early response to treatment | Platelet counts after 7 days of IVIG treatment | 7 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic Indicators | Calculate the total amount of IVIG used in 1 week (weight normalized) | 1 week | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Treatment-Emergent Adverse Events in 1 week | 1 week |