drugset / Trial / NCT01957176

A Rollover Study to Provide Continued Treatment With Eltrombopag

NCT01957176

Phase 4 Completed 22 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study was to provide continued treatment with eltrombopag for subjects who were participating in a Novartis-sponsored investigational study with eltrombopag (parent studies 114968/ASPIRE (NCT01440374), PMA112509 (NCT00903422), and TRA105325/EXTEND (NCT00351468), receiving clinical benefit without unacceptable toxicity and to collect long-term safety data.

Timeline

Start
2013-10-15
Primary completion
2022-02-23
Completion
2022-02-23

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
Subject Eltrombopag Small molecule 100 mg Oral
Subject Eltrombopag Small molecule 150 mg Oral
Subject Eltrombopag Small molecule 300 mg Oral

Indications