Alpha-1 Research Registry

Alpha 1-Antitrypsin Deficiency Clinical Trial

Official title:

Alpha-1 Research Registry Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04157049
• Other study ID #: Alpha-1 Registry Protocol
• Status: Recruiting
• Start date: June 20, 2019
• Est. completion date: June 20, 2029

Study information

• Verified date: January 2024
• Source: Alpha-1 Foundation
• Contact: Alison Keaveny, MBBS
• Phone: 1-877-228-7321
• Email: akeaveny[@]alpha1.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The purpose and goal of the Alpha-1 Research Registry (Registry, or group of patients) will be to obtain uniform, longitudinal (over the course of time), complete and accurate data that can be organized, and made available for the public to query. The collective number of Registry members enables investigators to enroll sufficient subjects to carry out their studies. The community benefits from having more research and potential therapies performed in their disease. Regular updates from patients will give objective data-points to measure the progression of disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: June 20, 2029
• Est. primary completion date: June 20, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with Alpha-1 Antitrypsin Deficiency (PiZZ, PiZNull, PiSZ etc.)

• Alpha-1 carriers (PiMZ, PiMS etc.)

Exclusion Criteria:

• Failure to provide informed consent

• Normal healthy individuals (MM)

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency

Locations

Country	Name	City	State
United States	Alpha-1 Foundation	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alpha-1 Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the Alpha-1 Research Registry using REDCap	To gather accurate patient data for longitudinal prospective follow up/analysis of Alpha-1 progression.	2 years