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

NCT02614872 | Completed Phase 2

• 1 other identifier: CT2-LUNG-IV-IL-014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung transplantation.

Conditions

Transplantation, Lung Rejection

Outcome Measures

Primary Outcomes (2)

• Incidence of subjects experiencing AEs and/or SAEs

  Incidence of subjects experiencing causally related AEs and/or SAEs

  during the study

• Incidence and rate of Acute Rejection

  Incidence and rate of Acute Rejection

  per year

Secondary Outcomes (3)

• Annual rate (per subject) of pulmonary infections

  per year

• Incidence of subjects who develop Bronchiolitis Obliterans

  during the study

• Changes in Pulmonary Function Test

  Change from baseline and overall effect

Study Arms (2)

GLASSIA®

EXPERIMENTAL

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

Drug: GLASSIA® and Institution standard of care (SOC)

Institution standard of care (SOC)

NO INTERVENTION

Institution standard of care (SOC) for first lung transplant subjects according to Investigator discretion.

Interventions

GLASSIA® and Institution standard of care (SOC) DRUG

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

Also known as: GLASSIA and Institution standard of care (SOC)

GLASSIA®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent.
• Age ≥18 years.
• Subject is planned to undergo first single or double lung transplant (including heart-lung transplant) as per standard implantation procedure.

You may not qualify if:

• Subject has immunoglobulin A (IgA) deficiency and known anti IgA antibodies.
• 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
• Subjects with a history of severe immediate hypersensitivity reactions, including allergies, anaphylaxis to plasma products or any human proteins of different source.
• 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.
• 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.
• Alcohol abuse or history of alcohol abuse.
• Illegal drugs.
• Candidate for organ transplantation other than first lung or heart-lung transplantation
• Clinically significant bronchial stenosis unresponsive to dilation and/or stenting
• Participation in another interventional clinical trial within 30 days prior to baseline visit.
• Inability to attend scheduled clinic visits and/or comply with the study protocol.
• Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.

Sponsors & Collaborators

• Kamada, Ltd.: lead

Study Sites (1)

Pulmonary Institute - Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Interventions

alpha 1-Antitrypsin

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Proteins; Alpha-Globulins; Serum Globulins; Globulins

Study Officials

• Mordechai Kramer, MD

  Pulmonary institute, Rabin Medical Center, Israel.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2015
• First Posted: November 25, 2015
• Study Start: July 26, 2016
• Primary Completion: April 11, 2019
• Study Completion: May 7, 2019
• Last Updated: September 1, 2021

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)