Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04565015
Status:
RECRUITING
Last Update Posted:
2023-05-17
First Post:
2020-09-07
Brief Title:
Study of Immune Globulin Intravenous Human GC5107 in Pediatric 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 Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous Human GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
Status:
RECRUITING
Status Verified Date:
2023-05
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:
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous Human GC5107 in pediatric subjects with Primary Humoral Immunodeficiency PHID
Detailed Description:
This is a prospective open-label single-arm historically controlled multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous Human GC5107 in pediatric subjects aged 2 years and 17 years with PHID
Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous IGIV maintenance therapy GC5107 will be infused every 21 or 28 days for a period of 12 months
Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous IGIV maintenance therapy GC5107 will be infused every 21 or 28 days for a period of 12 months
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