Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01406470
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2011-07-26
Brief Title:
Phase 3 Study of Immune Globulin Intravenous HumanIVIG-SN in Subjects With Primary Immunodeficiency
Sponsor:
Green Cross Corporation
Organization:
GC Biopharma Corp
Study Overview
Official Title:
An Open-Label Single-Arm Historically Controlled Prospective Multicenter Phase III Study to Evaluate the Safety Efficacy and Pharmacokinetics of Immune Globulin Intravenous Human IVIG-SN in Subjects With Primary Immunodeficiency
Status:
COMPLETED
Status Verified Date:
2014-01
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 pharmacokinetics of Immune Globulin Intravenous Human IVIG-SN in subjects with primary immunodeficiency diseases
Detailed Description:
This is an open-label single-arm historically controlled prospective multicenter phase III study to evaluate the safety efficacy and pharmacokinetics of Immune Globulin Intravenous Human IVIG-SN in subjects with primary immunodeficiency diseases
Subject will be infused every 21 to 28 days according to their previous IVIG treatment schedule Subjects treated every 28 days will receive 13 study IVIG infusions Subject treated every 21 days will receive 17 study IVIG infusions
Duration of treatmentThe total duration of treatment is 12 months
Subject will be infused every 21 to 28 days according to their previous IVIG treatment schedule Subjects treated every 28 days will receive 13 study IVIG infusions Subject treated every 21 days will receive 17 study IVIG infusions
Duration of treatmentThe total duration of treatment is 12 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IVIG_SN_P3 | OTHER_GRANT | Green Cross Corporation | None |