Clinical Trial

Management of Children With Persistent ITP, A Novel Approach

Study acronym: LMICs
Recruiting
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Record status
This record was last updated July 16, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
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 checkups during the study and for 6 months after treatment Report on bleeding episodes, physical activity, school attendance, and side effects
Trial Details
NCT Number NCT07068126
Lead Sponsor Assiut University
Collaborators: Zagazig University, Ain Shams University
Conditions Persistent Immune Thrombocytopenia
Enrollment 20 participants
Start Date 2025-01-01
Primary Completion 2025-12-30 (estimated)
Study Completion 2026-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-16