3상모집 중단 (진행 중)
A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Participants ≥16 Years of Age With Fabry Disease
연구 개요
This is a 12-month, parallel treatment, Phase 3, double-blind, randomized, placebo-controlled study to evaluate the effect of venglustat on neuropathic and abdominal pain symptoms of Fabry disease in participants ≥16 years of age with Fabry disease who are treatment-naïve or untreated for at least 6 months. * Study visits will take place approximately every 3 months. * The double-blind period will be followed by an open-label extension (OLE) during which participants who have completed the double-blind period will be treated with venglustat for an additional 12 months or until the Common Study End of Treatment Day (CSEOTD).
- 스폰서
- 리드: 사노피
- 적응증
- Fabry Disease
- 중재
- Venglustat (GZ402671), Placebo
- 목표 등록
- 122명
- 시작일
- 2022-03-11
- 완료(예정)
- 2027-01-04
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