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Clinical Trial Active — Not Recruiting Phase III NCT05280548

A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease

A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease — Active Not Recruiting •…

📅 24 Jun 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT05280548
Start
2022-05-03
Completion
2026-05-22
ClinicaliQ Trial Snapshot
  • A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease — Active Not Recruiting • Phase III • NCT05280548.
  • Venglustat compared to standard treatment for reducing heart thickening in adults with Fabry disease over 18 months.

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What This Trial Is Studying

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…

Full Trial Details
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Eligibility criteria, protocol, and results when available
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