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

Testing Venglustat's impact on heart health in Fabry disease patients.

Recruiting
18-65 years
All
Phase 3

This study is about testing a medicine called venglustat for adults with Fabry Disease, a rare genetic condition that can cause heart problems. The study will look at how venglustat affects the heart, specifically the Left Ventricular Mass Index (LVMI), which helps measure heart health. Participants will either take venglustat or keep receiving their usual treatment, like agalsidase alfa, agalsidase beta, or migalastat. The study lasts about 18 months with visits every 3 to 6 months. If participants want, they can continue for up to 4.4 years to study long-term effects.

  • Visits every 3 to 6 months.
  • Total study time can last up to 4.4 years.
  • Participants must be 18-65 years old with confirmed Fabry Disease.

It's important for participants to not have other major health issues like heart attacks, strokes, or certain infections. They need to agree to use contraception and not donate sperm if applicable. All participants must give consent before starting the study.

Study details
    Fabry Disease

NCT05280548

Sanofi

23 November 2024

Step 1 Get in touch with the nearest study center
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