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Sponsored by: |
Medical University of South Carolina |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00500123 |
The Alpha-1 Coded Testing (ACT) Study was established to study genetic testing and outcomes of individuals at risk for alpha-1 antitrypsin deficiency.
Condition | Intervention |
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Alpha 1-Antitrypsin Deficiency |
Procedure: Alpha-1 Antitrypsin Genotype |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Alpha-1 Coded Testing Study (ACT Trial) |
Estimated Enrollment: | 25000 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | January 2050 |
Estimated Primary Completion Date: | January 2050 (Final data collection date for primary outcome measure) |
Genetic testing for alpha-1 antitrypsin deficiency is sometimes delayed despite established testing indications. All genetic tests have risks and possible benefits. The ACT study evaluates the population demographics, reasons for testing, and outcomes through a confidential testing program. Concerns about genetic confidentiality are lessened in this study by a coded testing procedure that returns results through the mail to study participants. Outcomes of testing are recorded.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contact: Charlie Strange, M.D. | 843-792-0260 | alphaone@musc.edu |
United States, South Carolina | |
Medical University of South Carolina. Division of Pulmonary and Critical Care Medicine | Recruiting |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Charlie Strange, M.D. | Medical University of South Carolina |
Responsible Party: | Medical University of South Carolina ( Charlie Strange, M.D. ) |
Study ID Numbers: | HR 9556 |
Study First Received: | July 11, 2007 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00500123 |
Health Authority: | United States: Institutional Review Board |
alpha-1 antitrypsin AAT |
genetic testing alpha-1 antitrypsin deficiency AATD |
Protein C Inhibitor Alpha 1-Antitrypsin Protein C |
Alpha 1-Antitrypsin Deficiency Alpha 1-antitrypsin deficiency Connective Tissue Diseases |
Serine Proteinase Inhibitors Molecular Mechanisms of Pharmacological Action Trypsin Inhibitors |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |