NCT06545136Active, not recruitingPhase 1/2
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)
Source: ClinicalTrials.gov · Last updated 4 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 13 May 2024
- Primary completion date
- 31 May 2029
- Lead sponsor
- Spur Therapeutics
- Diseases
- Gaucher disease
- NCT number
- NCT06545136
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 75
- From 13 May 2024 to the primary completion date, 31 May 2029
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- n/a
Who the study is looking for
- 1\. Participants who have previously received FLT201 (including those who may have required recommencement or initiation of ERT/substrate reduction therapy \[SRT\]).
- 2\. Participants able to give full informed consent and able to comply with all requirements of the trial.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clínicas de Porto Alegre - HCPA Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital QuirónSalud Zaragoza Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Salford Royal Hospital Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Lysosomal Rare Disorders Research and Treatment Center Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.