Trials / Active Not Recruiting
Active Not RecruitingNCT06545136
Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)
A Multicenter, Long-term, Follow-up Study to Investigate the Safety and Durability of Response Following Dosing of an Adeno-associated Viral Vector (FLT201) in Subjects With Gaucher Disease (GALILEO-2)
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Spur Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, long-term, follow-up trial of participants with Gaucher disease type 1 who received FLT201 treatment in a preceding clinical trial. Participants will be followed for 5 years post-treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | FLT201 | FLT201 is a replication-incompetent single-stranded (ss) recombinant adeno-associated virus (AAV) vector. The vector is composed of a ss DNA genome packaged in an AAV-derived protein capsid. |
Timeline
- Start date
- 2024-05-13
- Primary completion
- 2029-05-01
- Completion
- 2029-05-01
- First posted
- 2024-08-09
- Last updated
- 2025-11-04
Locations
4 sites across 4 countries: United States, Brazil, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06545136. Inclusion in this directory is not an endorsement.