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ACTIVE NOT RECRUITING
NCT06545136
PHASE1/PHASE2

Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)

Sponsor: Spur Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-05-13

Completion Date

2029-05

Last Updated

2025-11-04

Healthy Volunteers

No

Interventions

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.

Locations (4)

Lysosomal Rare Disorders Research and Treatment Center

Fairfax, Virginia, United States

Hospital de Clinicas de Porto Alegre (HCPA)

Porto Alegre, Brazil

Hospital Quironsalud Zaragoza

Zaragoza, Spain

Salford Royal Hospital

Salford, United Kingdom