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

Phase 2

Completed

• Conditions: Transplantation, Lung Rejection
• Interventions: Drug: GLASSIA® and Institution standard of care (SOC)

• Registration Number: NCT02614872
• Lead Sponsor: Kamada, Ltd.

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.

Study Timeline

• Study First Submitted: 2015-11-15
• Study First Submitted QC: 2015-11-22
• Study First Posted: 2015-11-25
• Study Start: 2016-07-26
• Status Verified: 2019-02
• Primary Completion: 2019-04-11
• Study Completion: 2019-05-07
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLASSIA®	GLASSIA® and Institution standard of care (SOC)	Glassia® IV treatment additional to Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Annual rate (per subject) of pulmonary infections	per year	Annual rate (per subject) of pulmonary infections
Changes in Pulmonary Function Test	Change from baseline and overall effect	Changes in Pulmonary Function Test
Incidence of subjects who develop Bronchiolitis Obliterans	during the study	Incidence of subjects who develop Bronchiolitis Obliterans

Trial Locations

Locations (1)

Pulmonary Institute - Rabin Medical Center; 🇮🇱 Petach Tikva, Israel