Status:
ACTIVE_NOT_RECRUITING
Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)
Lead Sponsor:
Spur Therapeutics
Conditions:
Gaucher Disease, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 pos...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- n/a
Key Trial Info
Start Date :
May 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06545136
Start Date
May 13 2024
End Date
May 1 2029
Last Update
November 4 2025
Active Locations (4)
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1
Lysosomal Rare Disorders Research and Treatment Center
Fairfax, Virginia, United States, 22030-6066
2
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Brazil
3
Hospital Quironsalud Zaragoza
Zaragoza, Spain
4
Salford Royal Hospital
Salford, United Kingdom