Eltrombopag in Chronic ITP

Phase 4

• Conditions: Immune Thrombocytopenia

• Registration Number: NCT04102033
• Lead Sponsor: Assiut University

Brief Summary

This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Last Update Submitted: 2019-09-23
• Study First Posted: 2019-09-25
• Last Update Posted: 2019-09-25
• Study Start: 2019-11-01
• Primary Completion: 2020-11-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measuring the platelet count response to eltrombopag in pediatric chronic ITP	6 months