drugset / Trial / NCT04840667

A Study of Replagal in Treatment-naïve Adults With Fabry Disease

NCT04840667

Phase 3 Terminated 17 enrolled Shire
NaSingle-groupOpen-labelTreatment

Summary

In this study, adults with Fabry Disease who have not had any treatment for this condition will be treated with Replagal. The main aim of the study is to check if Replagal improves kidney function and heart structure of participants with Fabry Disease. Participants will receive one Replagal infusion every other week for up to 104 weeks. They will visit the clinic every 12 to 14 weeks during treatment with a follow-up visit 2 weeks after treatment.

Timeline

Start
2021-12-28
Primary completion
2022-12-16
Completion
2022-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Replagal Protein / enzyme biologic 0.2 mg/kg Intravenous

Indications