Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01628055
Status:
WITHDRAWN
Last Update Posted:
2013-11-11
First Post:
2012-06-14
Brief Title:
IVIG in Acute Ischemic Stroke A Pilot Study
Sponsor:
Inova Health Care Services
Organization:
Inova Health Care Services
Study Overview
Official Title:
IVIG in Acute Ischemic Stroke A Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficult recruitment and new black box warning for IVIG
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVIGAIS
Brief Summary:
The purpose of the study is to evaluate the ability of IVIG to affect the rate of progression of brain ischemia as evidenced by neuroimaging
The results of an ongoing epidemiological study indicate that patients with primary immunodeficiency PID on IVIG replacement therapy have an overall prevalence of stroke that is 5 times less than in the general population Even more striking is the absence of stroke in IVIG-treated PID patients over 65 while in the same general population age group the stroke prevalence goes up to 81 This suggests that the degree of stroke protection correlates with the length of IVIG treatment since older PID patients have been treated with IVIG significantly longer than younger ones
The results of an ongoing epidemiological study indicate that patients with primary immunodeficiency PID on IVIG replacement therapy have an overall prevalence of stroke that is 5 times less than in the general population Even more striking is the absence of stroke in IVIG-treated PID patients over 65 while in the same general population age group the stroke prevalence goes up to 81 This suggests that the degree of stroke protection correlates with the length of IVIG treatment since older PID patients have been treated with IVIG significantly longer than younger ones
Detailed Description:
Two pre-clinical studies demonstrated the effectiveness of IVIG preparations in improving the clinical outcome of stroke and at the same time provided evidence of the role of complement fragments in the pathogenesis of ischemia-induced brain damage Scavenging of these active fragments by IVIG is the likely mechanism of beneficial effect In one of these studies CSLs own Privigen preparation was used Considering that it exhibited in-vitro scavenging abilities more pronounced than several other IVIG preparations and that its in-vivo scavenging capacity was also proven in a relevant animal model a need to test this preparation in stroke patients is warranted In addition activation of complement and the level of activated fragments in humans seem to correlate with the severity of the disease making them an ideal therapeutic target
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