drugset / Trial / NCT04346654

A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP

NCT04346654

Phase 2 Completed 26 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to compare the ability of eltrombopag in combination with a short course of high-dose dexamethasone to induce sustained response off treatment in patients with newly-diagnosed ITP versus 1-3 cycles of dexamethasone monotherapy. The unmet clinical need and the potential for eltrombopag when added to steroids to improve the treatment outcome and the potential to induce sustained response off treatment serve as the basis for clinical investigation of eltrombopag in first-line ITP.

Timeline

Start
2020-10-09
Primary completion
2023-09-22
Completion
2023-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 40 mg Oral
Subject Eltrombopag Small molecule Oral