Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115778
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2005-06-26
Brief Title:
Intravenous Immunoglobulin IVIG in Lung Transplantation
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
IVIG for Acquired Immunodeficiency in Lung Transplant Patients
Status:
COMPLETED
Status Verified Date:
2019-02
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 if intravenous immunoglobulin IVIG can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin
Detailed Description:
An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia HGG In lung transplant recipients with HGG IVIG therapy offers the potential to significantly decrease the incidence and severity of infections thereby reducing morbidity and potentially mortality
Comparison The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients
Comparison The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients
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?:
False
Is an FDA AA801 Violation?:
None