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Enrolling By Invitation
NCT07898553
AATD-Liver Scan Study
Conditions: Alpha-1 Antitrypsin Deficiency, AATD, Alpha-1 Protease Inhibitor Deficiency, Alpha-1 AT Deficiency, Alpha-1 Antitrypsin Deficiency (AATD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Alpha-1 Foundation
Location: Alpha-1 Foundation Coral Gables Florida
Summary
The goal of this study is to provide liver stiffness screenings (FibroScans) to patients with Alpha-1 Antitrypsin Deficiency for the following purposes:
To evaluate the prevalence of elevated liver stiffness among homozygous and heterozygous individuals who carry mutations in the SERPINA1 gene.
To assess whether the coexistence of metabolic or environmental cofactors, such as obesity, diabetes, alcohol use, or hepatic steatosis, modifies the risk of liver fibrosis among those with alpha 1 antitrypsin deficiency.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of Alpha1 or a mutation in SERPINA1
* Enrollment in the Alpha-1 Research Registry
* Willingness to provide informed consent
* Aged 18 years and older
Exclusion Criteria:
* Inability to undergo VCTE (unable to lie flat for 10 minutes)
* Pregnancy (self-reported)
* Ascites (self-reported)
* Previous FibroScan in the last 365 days
* Previous liver transplant
Source: ClinicalTrials.gov (NCT07898553). StuddyBuddy aggregates publicly available trial information.