Eltrombopag in Chronic ITP

Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics

Sponsors

Lead Sponsor: Assiut University

Source Assiut University
Brief Summary

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

Overall Status Not yet recruiting
Start Date November 1, 2019
Completion Date January 1, 2021
Primary Completion Date November 1, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Measuring the platelet count response to eltrombopag in pediatric chronic ITP 6 months
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Eltrombopag

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

Eligibility

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.

Gender: All

Minimum Age: 1 Year

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Contact

Last Name: Gehad M. Abdelsalam, M.B.B.Ch

Phone: +201091294596

Email: [email protected]

Verification Date

September 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Assiut University

Investigator Full Name: GM Abdelsalam

Investigator Title: doctor

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov