Ignite Creation Date:
2024-05-06 @ 2:33 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02063789
Status:
COMPLETED
Last Update Posted:
2016-05-25
First Post:
2014-02-13
Brief Title:
An Open Phase 3 Study of IV-Globulin SN Inj10 to Treat Immune Thrombocytopenia
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
Prospective Non-Randomized Open-label Single-arm Multi-Center Phase III Clinical Trial to Evaluate the Efficacy and Safety of IV-Globulin SN Inj10 in the Patients Diagnosed With Immune Thrombocytopenia ITP
Status:
COMPLETED
Status Verified Date:
2016-05
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:
Human immunoglobulin Ig is the most commonly used blood product It has been well-defined the efficacy in patients with immunodeficiencies Kawasaki disease asthma and other immune diseases It is expected that Ig 10 will improve the usefulness and safety profile compared to Ig 5 because it is expected the reduced hospitalizationtreatment duration and less adverse events related to volume overload
Detailed Description:
GC5107A IV-Globulin SN Inj 10 is a polyvalent intravenous human immunoglobulin G preparation It is prepared from plasma collected from more than 1000 healthy blood donors and it expresses the large spectrum of antibody specificity
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