Alpha-1 Foundation Research Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medical University of South Carolina
Sponsor:
Collaborator:
Alpha-1 Foundation
Information provided by (Responsible Party):
Charlie Strange, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00499941
First received: July 11, 2007
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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
Alpha 1-Antitrypsin Deficiency

Study Type: Observational [Patient Registry]
Target Follow-Up Duration: 50 Years
Official Title: Alpha-1 Foundation Research Registry

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • To study the natural history of PiZZ, PiSZ, and PiMZ alpha-1 antitrypsin deficiency [ Time Frame: Not limited ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: April 2000
Estimated Study Completion Date: June 2050
Estimated Primary Completion Date: June 2050 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
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
Study First Received: July 11, 2007
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 28, 2014