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 treatment of Alpha-1 Antitrypsin (A1AT) deficiency.
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 enrolled into this LTFU study for continued safety monitoring for a 2-year period.
Study Type
OBSERVATIONAL
Enrollment
6
Subjects who received ADVM-043 in a parent study (ADVANCE; NCT02168686)
University of Florida
Gainesville, Florida, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Number of Participants With Adverse Events of Special Interest and of Serious Adverse Events Related to ADVM-043
All adverse events of special interest and all serious adverse events related to ADVM-043
Time frame: 2 years from start of long-term follow-up study ADVM-043-03 (NCT03804021) (2 years from completion of the parent study (ADVM-043-01, NCT02168686)
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