NCT05297812|Active Not RecruitingDMC
Alpha-1 Antitrypsin Disease Cohort: Longitudinal Biomarker Study of Disease
A1BC
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A1BC
Sponsor study identifier
Secondary identifiers
NIH
observational
286
1 country
9
Study Start
March 23, 2022
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 17, 2022
Actual (reported)March 23, 2022
Actual (reported)March 28, 2022
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in lung density over three years
Change in lung density over three years determined by using the 15th percentile point of Hounsfield units in inspiratory high resolution CT scans (PERC-15)
3 years
Patients with moderate or advanced Emphysema as measured by baseline inspiratory PERC-15 below the study median
Patients with minimal emphysema as measured by baseline inspiratory PERC-15 above the study median
Patients with Alpha-1 Antitrypsin Deficiency genotype ZZ across the United States.
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of California - Los Angeles
Los Angeles, California, 90095, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Chicago
Chicago, Illinois, 60637, United States
Boston University
Boston, Massachusetts, 02118, United States
Columbia University
New York, New York, 10032, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Blood samples will be collected for analysis in the ongoing clinical trial as well as for banking to for a bio-repository for future AATD studies. Participants will have the option to agree/not agree to partake in the optional bio-repository.
Jeanine M D'Armiento, MD, PhD
Columbia University
Charlie Strange, MD
Medical University of South Carolina
286 participants (actual enrollment reported by the registry).
First Submitted
March 17, 2022
First Posted
March 28, 2022
Study Start
March 23, 2022
Actual (reported)EARCO REGISTRY. History Of Patients With Alpha-1 Antitrypsin
Contact the study team to confirm eligibility.
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 16, 2026
Record last verified: 2026-01
This study is part of a larger research study where one of the objectives is to create a AATD de-identified, public use repository of data. This repository will be query based, and any sub-projects that stem from this will need to abide by the appropriate Human Subjects Protection, GCP guidelines (i.e., IRB protocol, local IRB approval, DUA, Release of Information) and be reviewed by the research committee including the Alpha-1 Foundation prior to release of any de-identified data.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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