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Clinical Trial Summary

An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/microL will be investigated.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00351468
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date June 2006
Completion date July 2015

See also
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Completed NCT01098487 - A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Phase 4
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Completed NCT00359463 - Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment Phase 1