Alpha-1 Research Registry

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Brief Title

Alpha-1 Research Registry

Official Title

Alpha-1 Research Registry Protocol

Brief Summary

      The Alpha-1 Research Registry is a confidential database made up of individuals diagnosed
      with Alpha-1 Antitrypsin Deficiency (Alpha-1) and individuals identified as Alpha-1 carriers.
      The Registry was established to facilitate research initiatives and promote the development
      of improved treatments and a cure for Alpha-1.
    

Detailed Description

      The purpose of the Alpha-1 Research Registry will be to obtain uniform, longitudinal,
      complete and accurate data that can be organized, de-identified (satisfying HIPAA safe harbor
      rules for the USA) and made available for the public to query. Updates from patients' medical
      information will provide objective data-points to measure the progression of disease. The
      goal of the Alpha-1 Research Registry is to build a clinical research registry that can meet
      the challenges of multiple competing research trials that require large numbers of AATD
      individuals. The Alpha-1 Research Registry will enroll individuals with AATD including
      carrier phenotypes.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Establish the Alpha-1 Research Registry using REDCap


Condition

Alpha 1-Antitrypsin Deficiency


Study Arms / Comparison Groups

 Alpha-1 Diagnosed Individuals
Description:  Larger patient cohorts are needed to support the clinical trials coming in the next 3-5 years. Despite widespread invitations to the Alpha-1 community from the Alpha-1 Foundation Research Registry, it is estimated that the Alpha-1 Foundation Research Registry now contains <40% of the identified PiZZ individuals in the US.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

4000

Start Date

June 20, 2019

Completion Date

June 20, 2029

Primary Completion Date

June 20, 2029

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with Alpha-1 Antitrypsin deficiency (ZZ)

          -  Alpha-1 carrier (MS)

        Exclusion :

          -  Failure to provide informed consent.

          -  Normal healthy individuals (MM)
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, 305-567-9888, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04157049

Organization ID

Alpha-1 Registry Protocol


Responsible Party

Sponsor

Study Sponsor

Alpha-1 Foundation


Study Sponsor

, , 


Verification Date

November 2019