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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02614872 | Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation | PHASE2 | COMPLETED | 30 | — | — | Jul 26, 2016 | May 7, 2019 | Sep 1, 2021 | 1 | Israel |
Incidence of subjects experiencing causally related AEs and/or SAEs
| Arm | Type | Description |
|---|---|---|
| GLASSIA® | EXPERIMENTAL | Glassia® IV treatment additional to Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion. |
| Institution standard of care (SOC) | NO_INTERVENTION | Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion. |
| Name | Type | Description |
|---|---|---|
| GLASSIA® and Institution standard of care (SOC) | DRUG | Alpha-1 Antitrypsin (AAT) \[GLASSIA®\] add-on pharmacotherapy and Institution standard of care (SOC) |
Inclusion Criteria: 1. Signed and dated informed consent. 2. Age ≥18 years. 3. Subject is planned to undergo first single or double lung transplant (including heart-lung transplant) as per standard implantation procedure. Exclusion Criteria: 1. Subject has immunoglobulin A (IgA) deficiency and kn...