Phase 2
N=11
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Hypogammaglobulinemia · Lung Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00115778 ↗Enrolled (actual)
11
Serious AEs
20.0%
Results posted
Mar 2019
Primary outcome: Primary: Number of Clinically Diagnosed Bacterial Infections During the Treatment Period — 3; 1 Infections
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IVIG (Drug); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Clinically Diagnosed Bacterial Infections During the Treatment Period |
3; 1 | — |
| SECONDARY Number of Clinically Diagnosed Viral Infections |
2; 2 | — |
| SECONDARY Number of Hospital Admissions |
3; 1 | — |
| SECONDARY Number of Antibiotic Initiation |
9; 8 | — |
| SECONDARY Number of Clinically Diagnosed Fungal Infection |
2; 0 | — |
| SECONDARY Number of Lymphocytic Bronchiolitis |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Lung transplant recipients > 3 months after transplant surgery
- Immunoglobulin G (IgG) < 500 mg/dL
- Stable medical regimen
Exclusion Criteria
- Acute rejection
- Active infection
- Contraindication to IVIG
- Pregnancy
- Recent thrombotic event
Data sourced from ClinicalTrials.gov (NCT00115778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.