Eltrombopag in Chronic ITP

Efficacy of Eltrombopag in Chronic Immune Thrombocytopenia in Pediatrics

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04102033

Enrollment

Registered

2019-09-25

Start date

2019-11-01

Completion date

2021-01-01

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia

Brief summary

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

Interventions

DRUGEltrombopag

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Measuring the platelet count response to eltrombopag in pediatric chronic ITP	6 months

Contacts

Primary ContactGehad M. Abdelsalam, M.B.B.Ch

gehad011157@med.au.edu.eg+201091294596

Backup ContactMohammed M. Hamdy Ghazaly, M.D.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026