Overview
Eltrombopag in Chronic ITP
Status:
Unknown status
Unknown status
Trial end date:
2021-01-01
2021-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Assiut University
Criteria
Inclusion Criteria:1. Pediatric patients with chronic ITP aged 1 to 17 years.
2. Platelet count is less than 30×109 per liter.
3. Patients neither have had spontaneous resolution of the thrombocytopenia nor responded
to corticosteroids and/or IV immunoglobulin.
Exclusion Criteria:
1. Patients with clinical and/or laboratory evidence of hepatotoxicity/liver
decompensation (Hepatotoxicity due to eltrombopag is defined as increased serum
alanine aminotransferase ≥3 times the upper limit of normal (ULN), aspartate
aminotransferase ≥3 ULN, alkaline phosphatase >1.5 ULN, total bilirubin >1.5 ULN)
2. Patients with history of thrombotic/thromboembolic events.