Mini-pool IVIG treatment for children with persistent ITP
Official title: "The Safety and Efficacy of Mini-Pool IVIG Initiation and Maintenance Therapy for Management of Children With Persistent ITP, A Novel Approach for LMICs"
Run by Assiut University · NCT07068126 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 10 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 3 sites (Asyut and 2 other locations) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 30, 2025 |
| Study ends | March 1, 2026 |
| Registry record updated | July 16, 2025 |
| Trial ID | NCT07068126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Oral Gabapentin vs IV Neostigmine/Atropine vs Both for Preventing PDPH
This study tests whether taking gabapentin by mouth, getting neostigmine with atropine by IV, or using both can help prevent postdural puncture headache after spinal anesthesia in pregnant patients.
-
Predicting Heart Muscle Recovery After CTO Revascularization
This study looks at whether blood tests and stress echo measurements can predict which patients with CTO will regain heart muscle function after a revascularization procedure.
-
Lower-dose induction for pediatric AML with G-CSF support
This study tests a lower-dose induction regimen with G-CSF in children with de novo acute myeloid leukemia to see if it lowers early toxicity without hurting survival.
-
Change in Fat Content of Bone Metastases After Treatment
This study tests if a special MRI method can see early changes in bone metastases by measuring fat content before and after chemotherapy or radiotherapy in adults.
-
Health education to see if primigravida women choose vaginal delivery more often
A health education program is being tested to see if it helps first-time pregnant women in choosing vaginal delivery over unnecessary cesareans.
-
Low-volume vs standard-volume ultrasound-guided bilateral intermediate cervical plexus block for thyroidectomy pain
This study tests whether using a smaller amount of local anesthetic on both sides before thyroidectomy can provide good pain relief while better preserving breathing.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.