Venglustat (GZ402671): Tablet; Oral
Agalsidase alfa: Concentrate for solution for infusion; IV infusion
Agalsidase beta (GZ419828): Powder for concentrate for solution for infusion; IV infusion
Migalastat: Hard capsules; Oral
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.
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama -The Kirklin Clinic- Site Number : 8400010 | Birmingham | Alabama | |
| University of California Los Angeles Medical Center- Site Number : 8400008 | Los Angeles | California | |
| Emory University School of Medicine - Atlanta- Site Number : 8400009 | Atlanta | Georgia | |
| Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400005 | Chicago | Illinois | |
| Maryam Banikazemi, MD- Site Number : 8400001 | Hawthorne | New York | |
| Renal Disease Research Institute- Site Number : 8400012 | Dallas | Texas | |
| University of Utah Health Hospital- Site Number : 8400006 | Salt Lake City | Utah | |
| Lysosomal and Rare Disorders Research and Treatment Center (LDRTC)- Site Number : 8400004 | Fairfax | Virginia | |
| Investigational Site Number : 0400001 | Graz | Austria | |
| Investigational Site Number : 1240003 | Calgary | Alberta | |
| Investigational Site Number : 1240006 | Edmonton | Alberta | |
| Investigational Site Number : 1240002 | Vancouver | British Columbia | |
| Investigational Site Number : 1240005 | Toronto | Ontario | |
| Investigational Site Number : 1560002 | Beijing | China | |
| Investigational Site Number : 1560005 | Beijing | China | |
| Investigational Site Number : 1560001 | Chengdu | China | |
| Investigational Site Number : 1560007 | Guangzhou | China | |
| Investigational Site Number : 1560003 | Shanghai | China | |
| Investigational Site Number : 2030001 | Prague | Czechia | |
| Investigational Site Number : 2080001 | Copenhagen | Denmark | |
| Investigational Site Number : 2500001 | Garches | France | |
| Investigational Site Number : 2760003 | Berlin | Germany | |
| Investigational Site Number : 2760004 | Hochheim am Main | Germany | |
| Investigational Site Number : 2760005 | Mainz | Germany | |
| Investigational Site Number : 2760001 | Würzburg | Germany | |
| Investigational Site Number : 3000002 | Athens | Greece | |
| Investigational Site Number : 3000003 | Athens | Greece | |
| Investigational Site Number : 3000001 | Heraklion | Greece | |
| Investigational Site Number : 3800001 | Milan | Lombardy | |
| Investigational Site Number : 3800002 | Naples | Napoli | |
| Investigational Site Number : 3800003 | Naples | Napoli | |
| Investigational Site Number : 3800004 | Bologna | Italy | |
| Investigational Site Number : 3920006 | Sapporo | Hokkaido | |
| Investigational Site Number : 3920007 | Kagoshima | Kagoshima-ken | |
| Investigational Site Number : 3920003 | Kagoshima | Kagoshima-ken | |
| Investigational Site Number : 3920005 | Kawasaki | Kanagawa | |
| Investigational Site Number : 3920002 | Sendai | Miyagi | |
| Investigational Site Number : 3920004 | Fukuoka | Japan | |
| Investigational Site Number : 3920001 | Tokyo | Japan | |
| Investigational Site Number : 5280001 | Amsterdam | Netherlands |
+ 14 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05280548 on ClinicalTrials.gov ↗ ← All trials in the UK