Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417573
Status:
COMPLETED
Last Update Posted:
2007-01-01
First Post:
2006-12-28
Brief Title:
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Sponsor:
The Center for Rheumatic Disease Allergy Immunology
Organization:
The Center for Rheumatic Disease Allergy Immunology
Study Overview
Official Title:
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
Status:
COMPLETED
Status Verified Date:
2006-12
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:
This is the first study that we are aware of that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency
Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease
Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease
Detailed Description:
10 consenting adults 18 or older will receive IgIV Gamunex 10 monthly at a dose of 400mgkg body weight IV at 3mlminute Comprehensive labs will be monitored at each visit as well as clinical eval plus patients will complete a questionnaire each time There is also a 3 month follow-up visit after completion of therapy Specific xrays will be done at the beginning and with the last treatment
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