Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370331
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2006-08-29
Brief Title:
RAISE Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura ITP Study With Eltrombopag
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase III Study to Evaluate the Efficacy Safety and Tolerability of Eltrombopag Olamine SB-497115-GR a Thrombopoietin Receptor Agonist Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP
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:
RAISE
Brief Summary:
The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP The starting dose of eltrombopag 50 mg once daily was selected based upon the observed efficacy safety and pharmacokinetics in a dose-finding Study TRA100773 This Phase III study is a randomized double-blind placebo-controlled Phase III study to evaluate efficacy safety and tolerability of eltrombopag initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP Subjects will be randomized 21 eltrombopag to placebo and will be stratified based upon splenectomy status use of ITP medication at baseline and baseline platelet count less than or equal to 15000µL Subjects will receive study medication for 6 months during which the dose of study medication may be adjusted based upon individual platelet counts In addition subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care After discontinuation of study medication subjects will complete follow-up visits at weeks 1 2 4 and months 3 and 6
Detailed Description:
A randomized double-blind placebo-controlled phase III study to evaluate the efficacy safety and tolerability of eltrombopag olamine SB-497115-GR a thrombopoietin receptor agonist administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP
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