3상모집 중단 (진행 중)

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

연구 개요

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.

스폰서
리드: 사노피
적응증
Fabry Disease
중재
Venglustat (GZ402671), Agalsidase alfa, Agalsidase beta (GZ419828), Migalastat
목표 등록
104
시작일
2022-05-03
완료(예정)
2027-12-06

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