Status:
UNKNOWN
Eltrombopag in Chronic ITP
Lead Sponsor:
Assiut University
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
1-17 years
Phase:
PHASE4
Brief Summary
This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.
Eligibility Criteria
Inclusion
- Pediatric patients with chronic ITP aged 1 to 17 years.
- Platelet count is less than 30×109 per liter.
- Patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or IV immunoglobulin.
Exclusion
- 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)
- Patients with history of thrombotic/thromboembolic events.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04102033
Start Date
November 1 2019
End Date
January 1 2021
Last Update
September 25 2019
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