Ignite Creation Date:
2024-05-05 @ 11:21 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01315496
Status:
TERMINATED
Last Update Posted:
2013-04-30
First Post:
2011-03-14
Brief Title:
GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
A Placebo-controlled Randomized Double-blind Multi-center Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of IV-Globulin S Inj in Adult Subjects With Community-Acquired Severe Sepsis or Septic Shock
Status:
TERMINATED
Status Verified Date:
2013-04
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:
This study is to determine whether the intravenous application of Ⅳ-Globulin S inj Human Immunoglobulin G can reduce mortality in patients with severe sepsis or septic shock
Detailed Description:
A Placebo-controlled Randomized Double-blind Multi-center Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of IV-Globulin S injHuman Immunoglobulin G as an Adjuvant Therapy in Adult Subjects with Community-Acquired Severe Sepsis or Septic Shock
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