Alpha-1 Antitrypsin Disease Cohort: Longitudinal Biomarker Study of Disease

Running, not enrolling

Conditions studied: Alpha 1-Antitrypsin Deficiency, Genetic Disease

In brief

Alpha-1 Anti-trypsin Deficiency (AATD) is a genetic disease with lung and liver disease presentations. The purpose of this study is to examine the density of the lung as measured by chest computed tomography (CT) and determine if existing emphysema predicts changes in the rate of subsequent emphysema or changes in CT, serum or plasma biomarkers of interest. The overarching goal is to develop biomarkers that can be used in interventional trials since lung function changes do not typically inform disease progression in AATD.

Key facts

Study ID

NCT05297812

Run by

Columbia University

People needed

286

Starts

2022-03-23

Expected to finish

2027-01-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged 18 years and older
• Patients with known Alpha-1 Anti-trypsin deficiency (PiZZ)
• Be an existing member of the Alpha-1 Foundation Clinical Cohort (Alpha-1 Foundation Research Registry)
• Willingness to perform study procedures of Chest CT, blood biomarker determination, questionnaire completion, and lung function testing.

You may not qualify if…

• AATD non-PiZZ status, including carriers
• Pregnancy at the time of the screening visit
• COPD exacerbation or other pulmonary infection within 6 weeks of baseline visit
• Previous lung or liver transplantation or currently on the transplant list

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California - Los Angeles — Los Angeles, California, United States
• National Jewish Health — Denver, Colorado, United States
• University of Chicago — Chicago, Illinois, United States
• Boston University — Boston, Massachusetts, United States
• Columbia University — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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