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Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children

Immune Thrombocytopenia Clinical Trial

Official title:
A Phase III Study of Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia in Children

Clinical Trial Summary

This is an investigator initiated, multicenter, open label, randomized phase 3 study for subjects with newly diagnosed ITP from ages 1 to less than 18 years old.

Clinical Trial Description

This is a prospective, open label, randomized, two-arm, multi-center Phase 3 trial. Patients with newly diagnosed ITP are randomized 2:1 to receive the experimental treatment, eltrombopag, or investigator's choice of 3 standard therapies. The primary objective is to determine if the proportion of patients with platelet response is significantly greater in patients treated with eltrombopag compared to those treated with standard therapies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03939637
Study type Interventional
Source Baylor College of Medicine
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 2, 2019
Completion date December 31, 2025
View Details
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