Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102739
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2005-02-01
Brief Title:
SB-497115 Oral Thrombopoietin Receptor Agonist Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura ITP
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
See Detailed Description
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a double-blind randomized placebo-controlled parallel group repeat-dose study conducted in two parts Part A and Part B examining 30 50 and 75 mg doses of SB-497115-GR as a treatment for patients with ITP who have failed prior therapy The study is designed to determine the proportion of patients with a platelet count 50000µL after 42 days In Part B 99 newly-recruited subjects will be randomized to one of two dosing arms in a 21 ratio of activeplacebo During the 6 week study period subjects will start on placebo or active drug 50 mg and may have a dose increase to 75 mg based upon their platelet count at day 22
Detailed Description:
A double-blind randomized placebo-controlled parallel group study to investigate the efficacy safety tolerability pharmacokinetics and pharmacodynamics of SB-497119-GR a thrombopoietin receptor agonist administered at 30 50 and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory chronic immune thrombocytopenia purpura
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