Ignite Creation Date:
2024-05-06 @ 12:13 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01524939
Status:
COMPLETED
Last Update Posted:
2012-09-20
First Post:
2012-01-25
Brief Title:
Study of Combined Therapy of Aspirin and IVIG-SN in Kawasaki Disease
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Multicenter Single-arm Phase IV Study to Evaluate the Efficacy Safety of Combined Therapy of Aspirin and High Dose IVIG-SN in Pediatric Patients With Kawasaki Disease
Status:
COMPLETED
Status Verified Date:
2012-01
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety efficacy and of Immune Globulin Intravenous Human IVIG-SN in subjects with kawasaki diseases
Detailed Description:
This clinical trial was designed as a multicenter single-arm and open-label clinical trial
Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration compared to the incidence of coronary artery lesions among untreated Kawasaki patients to prove the superior efficacy of IVIG-SN
Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration compared to the incidence of coronary artery lesions among untreated Kawasaki patients to prove the superior efficacy of IVIG-SN
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