Transplantation, Lung Rejection
Conditions
Brief summary
This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung transplantation.
Detailed description
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.
Interventions
DRUGGLASSIA® and Institution standard of care (SOC)
Alpha-1 Antitrypsin (AAT) \[GLASSIA®\] add-on pharmacotherapy and Institution standard of care (SOC)
Sponsors
Kamada, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 known anti IgA antibodies. 2. Known history of OR positive serological evidence at the time of screening for hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), Parvovirus B19 (PVB19) or human immunodeficiency virus (HIV) Type 1/2 infection 3. Subjects with a history of severe immediate hypersensitivity reactions, including allergies, anaphylaxis to plasma products or any human proteins of different source. 4. Pregnant or lactating women at entry to study and women of child bearing potential, who are unwilling to agree to continue to use acceptable methods of contraception throughout the study. 5. Presence of psychiatric/ mental disorder or any other medical disorder which might impair the subject's ability to give informed consent or to comply with the requirements of the study protocol. 6. Alcohol abuse or history of alcohol abuse. 7. Illegal drugs. 8. Candidate for organ transplantation other than first lung or heart-lung transplantation 9. Clinically significant bronchial stenosis unresponsive to dilation and/or stenting 10. Participation in another interventional clinical trial within 30 days prior to baseline visit. 11. Inability to attend scheduled clinic visits and/or comply with the study protocol. 12. Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subjects experiencing AEs and/or SAEs | during the study | Incidence of subjects experiencing causally related AEs and/or SAEs |
| Incidence and rate of Acute Rejection | per year | Incidence and rate of Acute Rejection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annual rate (per subject) of pulmonary infections | per year | Annual rate (per subject) of pulmonary infections |
| Incidence of subjects who develop Bronchiolitis Obliterans | during the study | Incidence of subjects who develop Bronchiolitis Obliterans |
| Changes in Pulmonary Function Test | Change from baseline and overall effect | Changes in Pulmonary Function Test |
Countries
Israel
Outcome results
None listed