Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

To be considered for this study, you would generally need to be between 18 and 70 years old and have been diagnosed with Alpha-1 Antitrypsin Deficiency (AATD). Doctors would need to confirm that your levels of the special blood protein (alpha-1 PI) are lower than normal. You also need to have been diagnosed with emphysema, a type of lung damage, and your breathing tests should show a certain level of reduced lung function.

There are also some important reasons why you might not be able to join. For example, if you've recently been on other treatments for Alpha-1 Antitrypsin Deficiency, had recent flare-ups of your lung condition, or if you've had certain lung surgeries or transplants, you might not be suitable. You also can't be currently smoking or have smoked within the last year, and you need to be able to have regular CT scans of your lungs.

Basically, the study is looking for people with a confirmed diagnosis of AATD and emphysema, who meet specific criteria for their lung function, and who haven't had other recent treatments or conditions that might affect the study results.

If you decide to take part in this study, it will last for a total of three years (156 weeks) for the main treatment period, plus a final check-up four weeks later. There will also be an initial screening phase to see if you're a good fit for the study.

During the study, you would receive the study medication (either Alpha-1 MP or the placebo) through an intravenous (IV) drip into your arm once a week. You would also have regular appointments at the study clinic for various health checks and assessments. The main way researchers will check if the treatment is working is by taking special scans of your lungs called CT scans at different points during the three years.