Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GLASSIA and Institution standard of care · 1 trial · 1 indication
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...
GLASSIA and Institution standard of care is being studied in lung transplantation, specifically for the prevention of lung rejection. It combines GLASSIA, an intravenous alpha-1 antitrypsin therapy, with the standard immunosuppressive regimen used at the transplant center. The approach is intended to support graft survival after lung transplant surgery.
Kamada Ltd., which trades on the Nasdaq under the ticker KMDA, is the developer of GLASSIA and Institution standard of care. Kamada is an Israeli plasma-derived protein therapeutics company. The combination regimen pairs the company's GLASSIA product with the standard of care used at participating transplant institutions.
GLASSIA and Institution standard of care is in Phase 2 clinical development. It is investigational and has not been approved for the lung transplantation or lung rejection indication. The Phase 2 study has been completed, and no trials of this combination are currently active.
GLASSIA and Institution standard of care was evaluated in one completed Phase 2 trial, NCT02614872, titled Study to Evaluate the Safety and Efficacy of Intravenous Glassia Treatment in Lung Transplantation. The trial enrolled 30 participants aged 18 years and older in Israel. It was randomized but not double blinded, with a no-treatment control.
GLASSIA and Institution standard of care is also written as GLASSIA and Institution standard of care (SOC). It refers to the combination of GLASSIA, an intravenous alpha-1 antitrypsin therapy, with the standard of care regimen used at the transplant institution, rather than GLASSIA administered on its own.