Eltrombopag in Chronic ITP

Phase 4UnknownNCT04102033

Assiut University20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immune Thrombocytopenia

Interventions

EltrombopagDRUG

Thrombopietic agent approved for its efficacy in chronic immune thrombocytopenia in pediatric patients

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Measuring the platelet count response to eltrombopag in pediatric chronic ITP

Time frame: 6 months

Central Contacts

Gehad M. Abdelsalam, M.B.B.Ch

CONTACT

+201091294596 gehad011157@med.au.edu.eg

Mohammed M. Hamdy Ghazaly, M.D.

CONTACT

+201001296603 mohamed.ghazali1@med.au.edu.eg

Data from ClinicalTrials.gov

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