Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102791
Status:
TERMINATED
Last Update Posted:
2008-03-27
First Post:
2005-02-01
Brief Title:
A Stratified Sickle Event Randomized Trial ASSERT
Sponsor:
Icagen
Organization:
Icagen
Study Overview
Official Title:
A Phase III Multicenter 52-Week Randomized Double-Blind Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had 2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months
Status:
TERMINATED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Because of the low probability of achieving the primary endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASSERT
Brief Summary:
The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea an oral drug used for treatment of sickle cell disease in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months
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