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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 4

Conditions: Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment

Treatments: Drug: intravenous immunoglobulin

Study type: Interventional

Funder types: Other

Identifiers

NCT05520892

2022YF024-01

Details and patient eligibility

About

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

Enrollment: 580 estimated patients

Sex: All

Ages: 29 days to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:

1. Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment
2. Age > 28 days and ≤ 14 years old
3. PLT<20×109/L
4. Have signed the informed consent

Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:

1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy
2. Received glucocorticoid or IVIG therapy within 6 months
3. Weight > 40kg
4. Menstrual female patients
5. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
6. Patients who have received radiotherapy and chemotherapy
7. 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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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580 participants in 2 patient groups

low-dose intravenous immunoglobulin

Experimental group

Description:

0.4g/kg.d, d1-5

Treatment:

Drug: intravenous immunoglobulin

high-dose intravenous immunoglobulin

Active Comparator group

Description:

1.0g/kg.d, d1-2

Treatment:

Drug: intravenous immunoglobulin