Actively Recruiting
Management of Children With Persistent ITP, A Novel Approach
Led by Assiut University · Updated on 2025-07-16
20
Participants Needed
3
Research Sites
60 weeks
Total Duration
On this page
Sponsors
A
Assiut University
Lead Sponsor
Z
Zagazig University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Management of Children With Persistent ITP, A Novel Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 10 years
- Male or female gender
- Diagnosis of persistent immune thrombocytopenia (ITP) according to ASH definition
- No previous treatment with thrombopoietin agonists
You will not qualify if you...
- History of severe adverse reactions to intravenous immunoglobulin (IVIG)
- Previous history of intracranial hemorrhage (ICH)
- Difficult venous access
- Presence of congenital thrombocytopenia, secondary ITP, or non-immune thrombocytopenia
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Children's hospital - Assiut University
Asyut, Egypt, 71515
Actively Recruiting
2
Ain Shams University
Cairo, Egypt, 11566
Actively Recruiting
3
Zagazig University, Pediatric departement
Zagazig, Egypt, 44519
Actively Recruiting
Research Team
M
Mohsen El Alfy, Professor
CONTACT
L
Laila M Sherief, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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