Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161993
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2005-09-08
Brief Title:
Safety Pharmacokinetic and Efficacy Study of a 10 Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency Hypo- or Agammaglobulinemia
Sponsor:
Baxalta now part of Shire
Organization:
Takeda
Study Overview
Official Title:
Prospective Open-Label Study of Pharmacokinetics Efficacy and Safety of Immune Globulin Intravenous Human 10 TVR Solution in Patients With Hypo- or Agammaglobulinemia
Status:
COMPLETED
Status Verified Date:
2021-08
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 determine the pharmacokinetics efficacy and safety of Immune Globulin Intravenous Human 10 TVR Triple Virally Reduced Solution in subjects with primary immunodeficiency PID manifesting as hypo- or agammaglobulinemia Subjects are treated every 21 days and receive a total of 12 infusions for the first 3 infusions subjects receive GAMMAGARD SD to ensure a steady-state and to acquire data with a licensed product for the remaining 9 infusions subjects receive IGIV 10 TVR Solution
Detailed Description:
None
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