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Management of Children With Persistent ITP, A Novel Approach

NCT07068126 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-16

No results posted yet for this study

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

Conditions

  • Persistent Immune Thrombocytopenia

Interventions

BIOLOGICAL

Mini-Pool IVIG

Mini-pool intravenous immunoglobulin (IVIG) is a plasma-derived biologic prepared from small pools of locally donated human plasma using a validated, virus-inactivated, closed-system process. Each participant will receive a loading dose of 1 g/kg infused intravenously over 6-8 hours. Maintenance doses of 0.5 g/kg will be given every 2 to 4 weeks for up to five additional doses, with the dosing schedule adjusted based on platelet count. The preparation contains purified IgG and meets safety standards for sterility and viral inactivation.

Sponsors & Collaborators

  • Zagazig University

    collaborator OTHER_GOV

  • Ain Shams University

    collaborator OTHER

  • Assiut University

    lead OTHER

Principal Investigators

  • Mervat M A Youssef, Assistant Professor · Assiut University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-30
Completion
2026-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07068126 on ClinicalTrials.gov