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45 Participants NeededMy employer runs this trial

FLT201 for Gaucher Disease

(GALILEO-3 Trial)

Recruiting at 2 trial locations
SC
Overseen BySpur Clinical Trials Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Spur Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a Phase 3, non-randomized, multicenter, efficacy and safety study in adult patients with Gaucher disease Type 1, on stable treatment with enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for at least 2 years. The study aims to confirm the efficacy and safety of FLT201 in this population after discontinuation of ERT/SRT.

Are You a Good Fit for This Trial?

Inclusion Criteria

Stable hemoglobin concentration at baseline
Stable platelet count at baseline
I am 18 years old or older.
See 2 more

Exclusion Criteria

Positive for AAVS3 neutralizing antibodies
I do not have lab results or health issues that would make me unsuitable for this study.
I have received gene therapy or cell therapy before.
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • FLT201

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: FLT201Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spur Therapeutics

Lead Sponsor

Trials
7
Recruited
150+

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