Trials / Active Not Recruiting
Active Not RecruitingNCT06488261
Long Term Follow-Up for Safety of AVR-RD-02
A Long-Term Follow-Up Safety Study of Subjects With Gaucher Disease Who Previously Received AVR-RD-02
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2 (actual)
- Sponsor
- John Bernat · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this observational study is to assess the safety and tolerability of AVR-RD-02 treatment in subjects who previously received AVR-RD-02 treatment (single dose administration).
Detailed description
Subjects who received AVR-RD-02 in the preceding treatment study (NCT04145037) and who meet all eligibility criteria may participate. Subjects will be asked to return for study visits annually for 14 years to assess measures of safety and persistence of AVR-RD-02 treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AVR-RD-02 | No study drug is administered in this study. Subjects who received AVR-RD-02 in a separate parent trial will be evaluated in this trial for long-term safety. |
Timeline
- Start date
- 2024-02-21
- Primary completion
- 2037-06-01
- Completion
- 2037-10-01
- First posted
- 2024-07-05
- Last updated
- 2025-07-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06488261. Inclusion in this directory is not an endorsement.