Status:
COMPLETED
Long-Term Follow-up Study of ADVM-043
Lead Sponsor:
Adverum Biotechnologies, Inc.
Conditions:
Alpha-1 Antitrypsin Deficiency
Eligibility:
All Genders
18+ years
Brief Summary
ADVM-043-03 is a long-term follow-up (LTFU) study of subjects who participated in the ADVM-043-01 (NCT02168686) multi-center gene therapy clinical study (ADVANCE) that evaluated ADVM-043 for the treat...
Detailed Description
ADVM-043-03 was a multi-center, observational study without administration of the ADVM-043 investigational product. Subjects who participated in the ADVANCE study (ADVM-043-01; NCT02168686) were enrol...
Eligibility Criteria
Inclusion
- Key
- The subject has A1AT deficiency and has previously received ADVM-043 gene therapy
- Key
Exclusion
- The subject is unwilling or unable to participate in all required study evaluations in the long-term follow-up protocol
- The subject is participating in another investigational treatment protocol
- The subject is unable to understand the purpose and risks of the study or cannot provide a signed and dated informed consent form (ICF)
Key Trial Info
Start Date :
December 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03804021
Start Date
December 27 2018
End Date
December 6 2021
Last Update
September 20 2024
Active Locations (2)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425