Active — Not RecruitingNot Applicable

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

United States286 participantsStarted 2022-03-23

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Change in lung density over three years

Timeframe: 3 years

Trial details

NCT IDNCT05297812

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Alpha 1-Antitrypsin Deficiency trials