Overview

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

Status:
Completed
Trial end date:
2019-05-07
Target enrollment:
0
Participant gender:
All
Summary
This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung transplantation.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kamada, Ltd.
Treatments:
Alpha 1-Antitrypsin
Criteria
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.