drugset / Trial / NCT02201290

A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

NCT02201290

Phase 3 Completed 9 enrolled Novartis Pharmaceuticals
Open-labelTreatment

Summary

This was an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450. This study allowed dosing of eltrombopag at an individualized dose for each subject based upon platelet count. The starting dose was based on the subject's dose at the end of the TRA115450 study. The maximum dose was 75 mg daily.

Timeline

Start
2013-06-18
Primary completion
2017-07-04
Completion
2017-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Eltrombopag Small molecule 12.5 mg Oral
Subject Eltrombopag Small molecule 25 mg Oral
Subject Eltrombopag Small molecule 50 mg Oral
Subject Eltrombopag Small molecule 75 mg Oral