- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157049
Alpha-1 Research Registry
January 29, 2024 updated by: Alpha-1 Foundation
Alpha-1 Research Registry Protocol
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.
Study Overview
Status
Recruiting
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
4000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alison Keaveny, MBBS
- Phone Number: 252 1-877-228-7321
- Email: akeaveny@alpha1.org
Study Contact Backup
- Name: Randel Plant
- Phone Number: 306 or 245 1-877-228-7321
- Email: rplant@alpha1.org
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33134
- Recruiting
- Alpha-1 Foundation
-
Contact:
- Alison Keaveny, MBBS
- Phone Number: 252 877-228-7321
- Email: akeaveny@alpha1.org
-
Contact:
- Nadine Nuchovich, MPH
- Phone Number: 245 1-877-228-7321
- Email: nnuchovich@alpha1.org
-
Principal Investigator:
- Jeanine D'Armiento, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The current protocol seeks to enroll 4,000 individuals of all age, race, and sex.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Alpha-1 Diagnosed Individuals
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.
|
Carriers of Alpha-1
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establish the Alpha-1 Research Registry using REDCap
Time Frame: 2 years
|
To gather accurate patient data for longitudinal prospective follow up/analysis of Alpha-1 progression.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2019
Primary Completion (Estimated)
June 20, 2029
Study Completion (Estimated)
June 20, 2029
Study Registration Dates
First Submitted
November 6, 2019
First Submitted That Met QC Criteria
November 6, 2019
First Posted (Actual)
November 8, 2019
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alpha-1 Registry Protocol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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