Ignite Creation Date:
2024-05-06 @ 1:21 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04003844
Status:
COMPLETED
Last Update Posted:
2020-05-21
First Post:
2019-05-16
Brief Title:
Study of Combined Therapy IVIG-SN 10 and Acetylsalicylic Acid 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 IVIG-SN 10 in Pediatric Patients With Kawasaki Disease
Status:
COMPLETED
Status Verified Date:
2020-05
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 efficacy and safety of high-dose human Immunoglobulin G Intravenous IGIV 10 in subjects with Kawasaki diseases KD
Detailed Description:
This is a multicenter single-arm and open-label clinical trial to evaluate the coronary artery lesions CALs at 2 and 7 weeks after single dose of IGIV 10 2 gkg administration for at least 12 hours to evaluate the efficacy and safety of IGIV 10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None