Phase 2
Completed N=11
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Hypogammaglobulinemia · Lung Transplantation
Source: ClinicalTrials.gov NCT00115778 ↗
Enrolled (actual)
11
Serious AEs
20.0%
Results posted
Mar 2019
Primary outcomePrimary: Number of Clinically Diagnosed Bacterial Infections During the Treatment Period — 3; 1 Infections
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.
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 | — |
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. Informational only — not medical advice.