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Search / Trial NCT07068126

Management of Children With Persistent ITP, A Novel Approach

Launched by ASSIUT UNIVERSITY · Jul 14, 2025

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat children with persistent immune thrombocytopenia (ITP), a condition where the blood has too few platelets, which help stop bleeding. The study wants to see if a treatment called mini-pool intravenous immunoglobulin (IVIG), made from small groups of donated plasma, is safe and helps increase platelet levels. Researchers also want to find out if this treatment reduces bleeding episodes and hospital visits for these children, and if there are any side effects.

Children between the ages of 1 and 10 who have persistent ITP and have not been treated with certain other medicines may be able to join. Participants will receive one dose of mini-pool IVIG through a vein over 6 to 8 hours, with possible follow-up doses every 2 to 4 weeks, up to five times, depending on their platelet counts. They will have regular blood tests and checkups during the study and for six months afterward. Families will also keep track of any bleeding, physical activities, school attendance, and side effects. This study does not compare the treatment to another, so all participants will receive the mini-pool IVIG.

Gender

ALL

Eligibility 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

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Cairo, , Egypt

Cairo, Abbassia, Egypt

Assiut, , Egypt

Zagazig, , Egypt

Patients applied

0 patients applied

Trial Officials

Mervat M A Youssef, Assistant Professor

Principal Investigator

Assiut University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported