Comparing two IVIG treatments for children with newly diagnosed ITP

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

This study is testing two different IVIG treatments to see which one works better for kids recently diagnosed with immune thrombocytopenia.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 580 (estimated)
• Ages: 29 Days to 14 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT05520892 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of two different dosage regimens of intravenous immune globulin (IVIG) for treating children who have recently been diagnosed with immune thrombocytopenia (ITP). The goal is to evaluate which regimen provides better efficacy while minimizing adverse reactions and reducing economic burdens, all while ensuring a high remission rate. The study will involve children aged between 29 days and 14 years who meet specific diagnostic criteria for ITP and have not received prior treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 29 days to 14 years who have been newly diagnosed with ITP and have a platelet count of less than 20×10^9/L.

Not a fit: Patients with severe bleeding complications, those who have received prior treatment for ITP, or those with significant underlying health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and safer treatment options for children with newly diagnosed ITP.

How similar studies have performed: Other studies have explored IVIG treatments for ITP, but this specific comparison of dosage regimens is novel.

Eligibility 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 -

Where this trial is running

Fuzhou, Fujian

• Children with newly dignosed ITP — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Shaohua Le, Master's degree

Conditions Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment