N/A
Completed N=6
Long-Term Follow-up Study of ADVM-043
Source: ClinicalTrials.gov NCT03804021 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Adverse Events of Special Interest and of Serious Adverse Events Related to ADVM-043 — 0; 0; 0; 0 participants
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 treatment of Alpha-1 Antitrypsin (A1AT) deficiency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events of Special Interest and of Serious Adverse Events Related to ADVM-043 |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- The subject has A1AT deficiency and has previously received ADVM-043 gene therapy
Key Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03804021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.