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Alpha-1 Foundation Research Registry

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ClinicalTrials.gov Identifier: NCT00499941
Recruitment Status : Recruiting
First Posted : July 12, 2007
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Alpha-1 Foundation
Information provided by (Responsible Party):
Charlie Strange, Medical University of South Carolina

Brief 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.

Condition or disease
Alpha 1-Antitrypsin Deficiency

Detailed 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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 50 Years
Official Title: Alpha-1 Foundation Research Registry
Study Start Date : April 2000
Estimated Primary Completion Date : June 2050
Estimated Study Completion Date : June 2050





Primary Outcome Measures :
  1. To study the natural history of PiZZ, PiSZ, and PiMZ alpha-1 antitrypsin deficiency [ Time Frame: Not limited ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals of all ages who are diagnosed with severe alpha-1 antitrypsin deficiency or the carrier state
Criteria

Inclusion Criteria:

  • Individuals of all ages who are diagnosed with severe alpha-1 antitrypsin deficiency or the carrier state

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499941


Contacts
Contact: Charlie Strange, M.D. 843-792-1219 alphaone@musc.edu
Contact: Charlie Strange, MD 843-792-3174 strangec@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina. Division of Pulmonary and Critical Care Medicine Recruiting
Charleston, South Carolina, United States, 29425
Contact: Charlie Strange, M.D.    843-792-1219    alphaone@musc.edu   
Principal Investigator: Charlie Strange, M.D.         
Sponsors and Collaborators
Medical University of South Carolina
Alpha-1 Foundation
Investigators
Principal Investigator: Charlie Strange, M.D. Medical University of South Carolina

Additional Information:
Publications of Results:
Other Publications:

Responsible Party: Charlie Strange, Professor of Pulmonary and Critical Care Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00499941     History of Changes
Other Study ID Numbers: HR 9059
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing is encouraged by coordinator contact at MUSC

Keywords provided by Charlie Strange, Medical University of South Carolina:
Alpha 1-Antitrypsin Deficiency

Additional relevant MeSH terms:
Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes