Active — Not RecruitingPhase 1/2

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

United States, Brazil, Spain75 participantsStarted 2024-05-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * n/a

What they're measuring

Incidence of treatment-emergent adverse events (TEAEs) (including DLTs)

Timeframe: Week 38 to Month 60

Trial details

NCT IDNCT06545136

SponsorSpur Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-05

View on ClinicalTrials.gov More Gaucher Disease, Type 1 trials