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NCT00499941 Clinical Trial

Alpha-1 Foundation Research Registry

Alpha 1-Antitrypsin Deficiency Clinical Trial

Official title:
Alpha-1 Foundation Research Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00499941
Other study ID # HR 9059
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2000
Est. completion date January 2021

Study information
Verified date February 2021
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The Alpha-1 Foundation Research Registry is a confidential database made up of individuals diagnosed with severe alpha-1 antitrypsin deficiency (Alpha-1) or the carrier state.

Description:

The Registry was established in 1997 by the Alpha-1 Foundation to facilitate research initiatives and promote the development of improved treatments and a cure for Alpha-1. Located at the Medical University of South Carolina (MUSC) in Charleston, the Registry employs procedures that ensure the most stringent confidentiality of participants. The Registry operates under the direction of the Alpha-1 Foundation Board of Directors and is guided by an Advisory Committee comprised of leaders in the medical, ethical, scientific and Alpha communities. Individuals enrolled in the Registry have the ongoing opportunity to participate directly in clinical trials of new therapeutic approaches in addition to other research opportunities.

Recruitment information / eligibility
Status Completed
Enrollment 6655
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Individuals of all ages who are diagnosed with severe alpha-1 antitrypsin deficiency or the carrier state

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Medical University of South Carolina. Division of Pulmonary and Critical Care Medicine Charleston South Carolina

Sponsors (2)
Lead Sponsor Collaborator
Medical University of South Carolina Alpha-1 Foundation

Country where clinical trial is conducted

United States, 

References & Publications (11)

Bowlus CL, Willner I, Zern MA, Reuben A, Chen P, Holladay B, Xie L, Woolson RF, Strange C. Factors associated with advanced liver disease in adults with alpha1-antitrypsin deficiency. Clin Gastroenterol Hepatol. 2005 Apr;3(4):390-6. — View Citation

Eden E, Strange C, Holladay B, Xie L. Asthma and allergy in alpha-1 antitrypsin deficiency. Respir Med. 2006 Aug;100(8):1384-91. Epub 2006 Jan 5. — View Citation

Holm KE, Borson S, Sandhaus RA, Ford DW, Strange C, Bowler RP, Make BJ, Wamboldt FS. Differences in adjustment between individuals with alpha-1 antitrypsin deficiency (AATD)-associated COPD and non-AATD COPD. COPD. 2013 Apr;10(2):226-34. doi: 10.3109/15412555.2012.719049. — View Citation

Holm KE, Wamboldt FS, Ford DW, Sandhaus RA, Strand M, Strange C, Hoth KF. The prospective association of perceived criticism with dyspnea in chronic lung disease. J Psychosom Res. 2013 May;74(5):450-3. doi: 10.1016/j.jpsychores.2013.02.001. Epub 2013 Feb 28. — View Citation

Hoth KF, Ford DW, Sandhaus RA, Strange C, Wamboldt FS, Holm KE. Alcohol use predicts ER visits in individuals with alpha-1 antitrypsin deficiency (AATD) associated COPD. COPD. 2012 Aug;9(4):417-25. doi: 10.3109/15412555.2012.684414. Epub 2012 May 31. — View Citation

Hoth KF, Wamboldt FS, Strand M, Ford DW, Sandhaus RA, Strange C, Bekelman DB, Holm KE. Prospective impact of illness uncertainty on outcomes in chronic lung disease. Health Psychol. 2013 Nov;32(11):1170-4. doi: 10.1037/a0032721. Epub 2013 Jun 17. — View Citation

McGee D, Strange C, McClure R, Schwarz L, Erven M. The Alpha-1 Association Genetic Counseling Program: an innovative approach to service. J Genet Couns. 2011 Aug;20(4):330-6. doi: 10.1007/s10897-011-9355-z. Epub 2011 Mar 19. — View Citation

Smith RA, Wienke S, Coffman DL. Alpha-1 couples: interpersonal and intrapersonal predictors of spousal communication and stress. J Genet Couns. 2014 Apr;23(2):212-20. doi: 10.1007/s10897-013-9639-6. Epub 2013 Aug 11. — View Citation

Smith RA, Wienke SE, Baker MK. Classifying married adults diagnosed with alpha-1 antitrypsin deficiency based on spousal communication patterns using latent class analysis: insights for intervention. J Genet Couns. 2014 Jun;23(3):299-310. doi: 10.1007/s10897-013-9661-8. Epub 2013 Nov 1. — View Citation

Stoller JK, Brantly M, Fleming LE, Bean JA, Walsh J. Formation and current results of a patient-organized registry for alpha(1)-antitrypsin deficiency. Chest. 2000 Sep;118(3):843-8. — View Citation

Williams PH, Shore L, Sineath M, Quill J, Warner B, Keith J, Walker D, Wienke S, Flavin S, Strange C. Genetics' influence on patient experiences with a rare chronic disorder: a photovoice study of living with alpha-1 antitrypsin deficiency. Nurs Clin North Am. 2013 Dec;48(4):627-36. doi: 10.1016/j.cnur.2013.09.008. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary To study the natural history of PiZZ, PiSZ, and PiMZ alpha-1 antitrypsin deficiency Not limited
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