drugset / Trial / NCT00864851

Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease

NCT00864851

Phase 3 Completed 44 enrolled Shire
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety and effectiveness of various doses of Replagal in patients with cardiomyopathy due to Fabry disease.

Timeline

Start
2008-12-29
Primary completion
2012-06-01
Completion
2012-07-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Replagal Protein / enzyme biologic 0.2 mg/kg Intravenous
Comparator Replagal Protein / enzyme biologic 0.4 mg/kg Intravenous

Indications