This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung transplantation.
There is clinical rationale to advocate the use of AAT(GLASSIA) therapy during episodes of lung inflammation, including acute and chronic rejection. AAT may provide more specifically targeted prevention of pathogenic inflammation, superior to that of general immunosuppressants, with little risk. AAT is the main inhibitor of Neutrophil elastase(NE) in the lower airways and patients with AAT deficiency have low concentrations of the protein in this region of the lung. This explains the proteinase/antiproteinase theory of the development of emphysema in deficient patients in which the amount of elastase released in the lung exceeds the amount of AAT. The net result is persistence of elastase activity leading to lung destruction and the pathological changes of emphysema. Administration of AAT will help to prevent further destruction of the lung architecture and reduce the inflammatory dysregulation that causes pulmonary dysfunction. It is expected that by attacking a specific and previously untreated key component of the pathophysiological cycle of BOS, AAT therapy would decrease the prevalence of BOS in lung transplant recipients and prolong life expectancy of these patients. This will be an open label study in order to ensure safety, in the frame of POC study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Alpha-1 Antitrypsin (AAT) \[GLASSIA®\] add-on pharmacotherapy and Institution standard of care (SOC)
Pulmonary Institute - Rabin Medical Center
Petah Tikva, Israel
Incidence of subjects experiencing AEs and/or SAEs
Incidence of subjects experiencing causally related AEs and/or SAEs
Time frame: during the study
Incidence and rate of Acute Rejection
Incidence and rate of Acute Rejection
Time frame: per year
Annual rate (per subject) of pulmonary infections
Annual rate (per subject) of pulmonary infections
Time frame: per year
Incidence of subjects who develop Bronchiolitis Obliterans
Incidence of subjects who develop Bronchiolitis Obliterans
Time frame: during the study
Changes in Pulmonary Function Test
Changes in Pulmonary Function Test
Time frame: Change from baseline and overall effect
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