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NCT05280548 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease
A Phase 3 study of Fabry Disease, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
- 20
- Study locations
NCT05280548 is a Phase 3 study of Fabry Disease that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 104 participants, below the 540-participant average among 32 other Fabry Disease trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT05280548, a Phase 3 study of Fabry Disease, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3 study, in which participants will be randomized to venglustat versus standard of care therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of venglustat on left ventricular mass index (LVMI) in adult participants with Fabry disease and left ventricular hypertrophy. * Study visits will take place approximately every 3 to 6 months * Participants who complete the randomized period may continue to the long-term extension (LTE) to receive venglustat for up to additional 45 months with the total study duration up to 5.3 years maximum.
Conditions Studied
Interventions
- DRUG Venglustat (GZ402671)
- DRUG Agalsidase alfa
- DRUG Agalsidase beta (GZ419828)
- DRUG Migalastat
Study Locations (20)
Other
- Investigational Site Number : 0400001 - Graz
- Investigational Site Number : 1560002 - Beijing
- Investigational Site Number : 1560005 - Beijing
- Investigational Site Number : 1560001 - Chengdu
- Investigational Site Number : 1560007 - Guangzhou
- Investigational Site Number : 1560003 - Shanghai
- Investigational Site Number : 2030001 - Prague
- Investigational Site Number : 2080001 - Copenhagen
Alberta
- Investigational Site Number : 1240003 - Calgary
- Investigational Site Number : 1240006 - Edmonton
Alabama
- University of Alabama -The Kirklin Clinic- Site Number : 8400010 - Birmingham
California
- University of California Los Angeles Medical Center- Site Number : 8400008 - Los Angeles
Georgia
- Emory University School of Medicine - Atlanta- Site Number : 8400009 - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400005 - Chicago
New York
- Maryam Banikazemi, MD- Site Number : 8400001 - Hawthorne
Texas
- Renal Disease Research Institute- Site Number : 8400012 - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2027-12-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05280548
The ClinicalTrials.gov registry entry for NCT05280548 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 540-participant average among 32 other Fabry Disease trials with a reported enrollment target (81% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 4 interventions - of which Venglustat (GZ402671) is the first listed.
NCT05280548 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Alberta, Alabama.
Frequently Asked Questions
What is clinical trial NCT05280548 about?
NCT05280548 is a clinical study titled "A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease". This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3 study, in which participants will be randomized to venglustat versus standard of care therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of venglustat on left ventricular mass index (LV...
What is the current status of trial NCT05280548?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2022-05-03. Estimated completion is 2027-12-06.
What conditions does trial NCT05280548 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT05280548?
The interventions under investigation include: Venglustat (GZ402671) (DRUG), Agalsidase alfa (DRUG), Agalsidase beta (GZ419828) (DRUG), Migalastat (DRUG).
Who is sponsoring clinical trial NCT05280548?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05280548 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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