The Safety and Efficacy of Mini-Pool IVIG Initiation and Maintenance Therapy for Management of Children With Persistent ITP, A Novel Approach for LMICs

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 10
Healthy Volunteers: f
View:

• Gender: Males and Females

• Persistent ITP according to ASH definition

• No history of treatment with thrombopoietin agonists

Locations
Other Locations
Egypt
Children's hospital - Assiut University
RECRUITING
Asyut
Ain Shams University
RECRUITING
Cairo
Zagazig University, Pediatric departement
RECRUITING
Zagazig
Contact Information
Primary
Mohsen El Alfy, Professor
Elalfym@hotmail.com
+201000864343
Backup
Laila M Sherief, Professor
lamesh25@yahoo.com
+201001891964
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 20
Treatments
Experimental: Mini-Pool IVIG Treatment Arm
Participants in this arm will receive mini-pool intravenous immunoglobulin (IVIG) as second-line therapy for persistent immune thrombocytopenia (ITP). Treatment includes a loading dose of 1 g/kg infused over 6-8 hours, followed by maintenance doses of 0.5 g/kg given every 2 to 4 weeks for up to five additional doses. The dosing interval is adjusted based on each participant's platelet count. Participants will have regular blood tests and clinical assessments to monitor platelet levels, bleeding episodes, and treatment safety.
Sponsors
Leads: Assiut University
Collaborators: Ain Shams University, Zagazig University

This content was sourced from clinicaltrials.gov

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