Intravenous Immunoglobulin (IVIG) in Lung Transplantation
NCT00115778 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2019-03-05
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.
Conditions
- Hypogammaglobulinemia
- Lung Transplantation
Interventions
- DRUG
-
IVIG
10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks
- OTHER
-
Placebo
0.1% Albumin in an equal volume to the investigational product
Sponsors & Collaborators
-
Grifols Therapeutics LLC
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Selim M Arcasoy, M.D. · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 12 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-06-30
- Primary Completion
- 2009-08-31
- Completion
- 2010-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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