Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00115778 | Intravenous Immunoglobulin (IVIG) in Lung Transplantation | PHASE2 | COMPLETED | 11 | — | — | Jun 1, 2005 | Aug 1, 2010 | Mar 5, 2019 | 1 | United States |
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
| Arm | Type | Description |
|---|---|---|
| First IVIG, then Placebo | EXPERIMENTAL | Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks. |
| First Placebo, then IVIG | EXPERIMENTAL | Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks. |
| Name | Type | Description |
|---|---|---|
| IVIG | DRUG | 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks |
| Placebo | OTHER | 0.1% Albumin in an equal volume to the investigational product |
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