FAQ
What does an A1BC participant have to do?
- Sign an informed consent
- Complete questionnaires, lung function tests, a CT scan, sputum collection and blood collection
- Agree to return in 18 months and 36 months for repeat testing
- Be willing to talk to coordinator monthly about your health
Who is eligible for the A1BC?
Individuals over age 18 diagnosed with PiZZ Alpha-1.
How do I enroll in the A1BC?
To enroll in A1BC you first need to be a member of the Alpha-1 Research Registry and help us find a cure.
Who is eligible for the Alpha-1 Registry?
- Individuals of all ages diagnosed with Alpha-1
- Individuals of all ages identified as Alpha-1 carriers
What does a Registry participant have to do?
- Complete a registration form
- Sign an informed consent
- Complete a questionnaire
- Provide reports of medical tests and labs (optional)
- Receive follow-up calls every 1-2 years to collect updated information
Research staff are available to assist participants through the enrollment process and to answer any questions.
Once you are in the Registry, you will need to contact and travel to an A1BC site to join this study. Sites are listed on this website and on clinicaltrials.gov.
The study coordinator at the A1BC site will discuss your eligibility on the telephone or by email and schedule a study visit convenient to you both.
Do I have to stop any current treatments to be a part of the A1BC?
No, you do not have to stop any current treatments, including your alpha-1 antitrypsin augmentation therapy.
Is there a study drug that must be taken to enroll in the A1BC?
No, this study is purely an observational study with an aim of identifying biomarkers, clinical events and features on CT imaging that may allow us to identify early changes on imaging or in the blood before clinical deterioration.
If I enroll in the A1BC, does this mean I cannot be join other studies?
If you enroll in the A1BC, you can still participate in other clinical research studies. You just cannot be in the active arm of a therapeutic trial at the time of enrollment. Please discuss with your site investigator or coordinator if you plan on enrolling in another study or are enrolled in another study but would like to participate in the A1BC after that study is completed.
Can pregnant women participate in this study?
Women of childbearing age will be permitted to be in the study. Pregnant women will not be able to do any CT scans and will have to defer the CT scan to a later date.
What is purpose for the A1BC Study?
Progression of lung disease in patients with Alpha-1 antitrypsin deficiency is variable and while some patients may have stable lung function over many years, some progress and have a RAPID deterioration. Currently there are no predictors that would help us identify patients at risk of rapid deterioration. The aim of this study is to identify biomarkers, clinical events, and features in CT imaging that may allow us to identify these patients earlier in the disease course.
