Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02783482
Status:
COMPLETED
Last Update Posted:
2022-12-09
First Post:
2016-04-24
Brief Title:
Study of Immune Globulin Intravenous Human GC5107 in Subjects With Primary Humoral 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 GC5107 in Subjects With Primary Humoral Immunodeficiency
Status:
COMPLETED
Status Verified Date:
2022-09
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 GC5107 in subjects with Primary Humoral Immunodeficiency PHID
Detailed Description:
This was a prospective open-label single-arm historically controlled multicenter phase 3 study measuring the safety efficacy and pharmacokinetics and tolerability of GC5107 in subjects with Primary Humoral Immunodeficiency disease PHID
Subjects received intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous IVIG maintenance therapy GC5107 was administered every 21 or 28 days for a period of 12 months
Subjects received intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous IVIG maintenance therapy GC5107 was administered every 21 or 28 days for a period of 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