About InnovAATe Study
InnovAATe is a phase 3 clinical study testing the safety and effectiveness of inhaled Alpha 1 Antitrypsin (AAT) in adults with lung disease due to Alpha-1 Antitrypsin Deficiency.
This study is part of a clinical development program lead by KAMADA Ltd., the manufacturer of AAT for inhalation.
Participating in the study involves daily inhalation at home and periodic clinical evaluation at a medical institution.
This study is part of a clinical development program lead by KAMADA Ltd., the manufacturer of AAT for inhalation.
Participating in the study involves daily inhalation at home and periodic clinical evaluation at a medical institution.
What is inhaled AAT?
Inhaled AAT is an investigational medicine.
It contains Alpha-1 Antitrypsin protein as the active ingredient and is delivered directly to the lungs through a specialized nebulizer at home.
Administration of inhaled AAT aims to replace the deficient AAT protein in the lung of patients with severe AAT deficiency.
Inhalation is a convenient, non-invasive, and widely used therapeutic approach to deliver medicines directly to the lungs.
Who can participate in the InnovAATe study?
This is only a selection of the key inclusion and exclusion criteria. There are additional requirements
which can be reviewed and explained by the study doctor.
which can be reviewed and explained by the study doctor.
You may qualify for the InnovAATe study if you are:
- Between the ages of 18 to 65 years
- Have a deficiency genotype of PiZZ, PiZ/Null or Pi(Null/Null)
- Serum Alpha-1 Antitrypsin levels below 11 μM (micro molar)
- Have lung disease with evidence of airflow limitation
- Your post-bronchodilator FEV1% is between 40 and 80 percent of predicted
Subjects who may not be able to participate:
- IgA Deficiency
- A history of life-threatening transfusion reaction(s), allergy, anaphylactic reaction, or systemic response to human plasma derived products
- Have had a lung or liver transplant
- Are currently smoking or have smoked in the past year
