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Management of Children With Persistent ITP, A Novel Approach

RecruitingNAAges 1 Year - 10 YearsAllAssiut University
NCT07068126 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if mini-pool intravenous immunoglobulin (IVIG) is a safe and effective treatment for children with persistent immune thrombocytopenia (ITP). ITP is a condition that causes low platelet levels and increases the risk of bleeding. The main questions this study aims to answer are: Can mini-pool IVIG raise platelet levels in children with persistent ITP? Can it reduce bleeding episodes and hospital visits? What side effects, if any, are seen with this treatment? There is no comparison group in this study. All participants will receive mini-pool IVIG, which is made from small pools of donated plasma using a cost-effective process. Participants will: Receive one dose of mini-pool IVIG through a vein over 6 to 8 hours Receive follow-up doses every 2 to 4 weeks for up to 5 doses, based on their platelet count Have regular blood tests and checkup

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📋 Eligibility rules (as published)
Inclusion Criteria:Age 1 - 10 years * Gender: Males and Females * Persistent ITP according to ASH definition * No history of treatment with thrombopoietin agonists Exclusion Criteria:-History of severe drug adverse events to IVIG * Previous history of ICH * Difficult venous access * Congenital thrombocytopenia, secondary ITP and non-immune thrombocytopenia
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What it tests

  • Mini-Pool IVIG
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Where

3 sites
Children's hospital - Assiut University
Asyut, Egypt
Ain Shams University
Cairo, Egypt
Zagazig University, Pediatric departement
Zagazig, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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