Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351468
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2006-07-10
Brief Title:
EXTEND Eltrombopag Extended Dosing Study
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
EXTEND Eltrombopag Extended Dosing Study An Extension Study of Eltrombopag Olamine SB-497115-GR in Adults With Idiopathic Thrombocytopenic Purpura ITP Previously Enrolled in an Eltrombopag Study
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXTEND
Brief 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 50000μL will be investigated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None