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NCT06545136 · ClinicalTrials.gov registry record · Phase 1
Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)
A Phase 1 study of Gaucher Disease, Type 1, sponsored by Spur Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 4
- Study locations
NCT06545136: Active Phase 1 study of Gaucher Disease, Type 1, sponsored by Spur Therapeutics.
NCT06545136 is a Phase 1 study of Gaucher Disease, Type 1 that is active but no longer recruiting, run by Spur Therapeutics. The registered enrollment target is 75 participants, above the 50-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (50% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06545136, a Phase 1 study of Gaucher Disease, Type 1, is active but no longer recruiting, sponsored by Spur Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Treatment-emergent adverse events (including dose-limiting toxicities), with AEs graded per CTCAE version 5.0 (or later)
Conditions Studied
Interventions
- GENETIC FLT201
Study Locations (4)
Other
- Hospital de Clinicas de Porto Alegre (HCPA) - Porto Alegre
- Hospital Quironsalud Zaragoza - Zaragoza
- Salford Royal Hospital - Salford
Virginia
- Lysosomal Rare Disorders Research and Treatment Center - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-05-13 |
| Est. Completion | 2029-05 |
| Phase | Phase 1 |
What the registry record for NCT06545136 still lists
NCT06545136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 50-participant average among 8 other Gaucher Disease, Type 1 trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Gaucher Disease, Type 1 appearing as the primary indexed condition, and to 1 intervention - of which FLT201 is the first listed.
NCT06545136 reports a single indexed study location in Other, Virginia.
Frequently Asked Questions
What is clinical trial NCT06545136 about?
NCT06545136 is a clinical study titled "Long Term Follow-up Study of Type-1 Gaucher Subjects Post FLT201 Dose (GALILEO-2)". 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.
What is the current status of trial NCT06545136?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2024-05-13. Estimated completion is 2029-05.
What conditions does trial NCT06545136 study?
This clinical trial studies the following conditions: Gaucher Disease, Type 1.
What interventions are being tested in trial NCT06545136?
The interventions under investigation include: FLT201 (GENETIC).
Who is sponsoring clinical trial NCT06545136?
This trial is sponsored by Spur Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06545136 being conducted?
This trial has 4 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06545136's enrollment target sits among peer trials
75 3rd of 8 higher than 6 of 8 other Gaucher Disease, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gaucher Disease, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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