Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168025
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2005-09-12
Brief Title:
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies PID
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
A Multicenter Study on the Efficacy Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency PID
Status:
COMPLETED
Status Verified Date:
2012-06
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 demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency
As secondary endpoints the rate of overall infections the tolerability and safety of IgPro10 are studied
A part of the patients are participating in a pharmacokinetic substudy
As secondary endpoints the rate of overall infections the tolerability and safety of IgPro10 are studied
A part of the patients are participating in a pharmacokinetic substudy
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