Ignite Creation Date:
2024-05-06 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03492710
Status:
WITHDRAWN
Last Update Posted:
2020-07-07
First Post:
2018-02-19
Brief Title:
Study of Immune Globulin Intravenous Human GC5101F in Subjects With Primary Humoral Immunodeficiency
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Phase III Study of Immune Globulin Intravenous Human IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A change in sponsors developmental strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety efficacy and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases PHID
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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