Trials / Completed
CompletedNCT03804021
Long-Term Follow-up Study of ADVM-043
Post-treatment Long-term Follow-up Study of ADVM-043 Gene Therapy in Alpha-1 Antitrypsin Deficiency
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 6 (actual)
- Sponsor
- Adverum Biotechnologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 enrolled into this LTFU study for continued safety monitoring for a 2-year period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | No Intervention | Subjects who received ADVM-043 in a parent study (ADVANCE; NCT02168686) |
Timeline
- Start date
- 2018-12-27
- Primary completion
- 2021-12-06
- Completion
- 2021-12-06
- First posted
- 2019-01-15
- Last updated
- 2024-09-20
- Results posted
- 2024-09-20
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03804021. Inclusion in this directory is not an endorsement.