Mini-pool IVIG treatment for children with persistent ITP
"The Safety and Efficacy of Mini-Pool IVIG Initiation and Maintenance Therapy for Management of Children With Persistent ITP, A Novel Approach for LMICs"
This trial will test whether mini-pool IVIG given to children ages 1–10 with persistent ITP can raise platelet counts and reduce bleeding and hospital visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year to 10 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 3 sites (Asyut and 2 other locations) |
| Trial ID | NCT07068126 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective study will enroll 20 children aged 1–10 years with persistent ITP at three tertiary pediatric hematology centers in Egypt. All participants will receive a loading dose of mini-pool IVIG 1 g/kg followed by maintenance doses of 0.5 g/kg every 2–4 weeks for up to five additional doses, with intervals adjusted by platelet counts. There is no comparison group; safety and effectiveness will be tracked using regular blood counts, Bleeding Assessment Tool (BAT) scores, reports of bleeding episodes and hospital visits, and monitoring for side effects during treatment and for six months afterward. Mini-pool IVIG is produced locally from small plasma pools with virus inactivation and IgG purification to offer a lower-cost alternative suited to resource-limited settings.
Who should consider this trial
Good fit: Children aged 1–10 years with persistent ITP (3–12 months since diagnosis) who have not received thrombopoietin receptor agonists and do not have congenital or secondary causes of thrombocytopenia are ideal candidates.
Not a fit: Children with congenital thrombocytopenia, non-immune causes of low platelets, prior severe reactions to IVIG, prior intracranial hemorrhage, or difficult venous access are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide an effective, lower-cost IVIG option that raises platelet counts and reduces bleeding and hospital visits for children with persistent ITP, especially in resource-limited settings.
How similar studies have performed: Prior reports indicate mini-pool IVIG is effective and well tolerated for acute pediatric ITP, but its role as a second-line therapy for persistent ITP has not been evaluated in prospective multicenter trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Asyut and 2 other locations
- Children's hospital - Assiut University — Asyut, Egypt (Recruiting)
- Ain Shams University — Cairo, Egypt (Recruiting)
- Zagazig University, Pediatric departement — Zagazig, Egypt (Recruiting)
Study contacts
- Principal investigator: Mervat M A Youssef, Assistant Professor — Assiut University
- Study coordinator: Mohsen El Alfy, Professor
- Email: Elalfym@hotmail.com
- Phone: +201000864343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.