Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419341
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2006-12-22
Brief Title:
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
A Phase III Open-Label Prospective Multicenter Study of the Efficacy Tolerability Safety and Pharmacokinetics of Immune Globulin Subcutaneous Human IgPro20 in Subjects With Primary Immunodeficiency PID
Status:
COMPLETED
Status Verified Date:
2012-12
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 objective of this study is to assess the efficacy tolerability safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency PID
Detailed Description:
The entire study consists of a 12-week wash-inwash-out period followed by a 12-month treatment period Pharmacokinetic PK parameters were assessed in a sub-group of subjects
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 |
|---|---|---|---|
| 1458 | OTHER | CSL Behring | None |