NCT02614872

Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation

A Proof of Concept (POC) Study, Phase II, Open Label, Randomized, Standard Care - Controlled, Single Center Study Evaluating the Safety and Efficacy of Human, Alpha-1 Antitrypsin (AAT) [GLASSIA®] Treatment in First Lung Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Kamada, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transplantation, Lung Rejection

Interventions

Type	Name	Description
DRUG	GLASSIA® and Institution standard of care (SOC)	Alpha-1 Antitrypsin (AAT) \[GLASSIA®\] add-on pharmacotherapy and Institution standard of care (SOC)

Timeline

• Start date: 2016-07-26
• Primary completion: 2019-04-11
• Completion: 2019-05-07
• First posted: 2015-11-25
• Last updated: 2021-09-01

Locations

1 site across 1 country: Israel