drugset / Trial / NCT00140621
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of agalsidase beta (Fabrazyme \[recombinant form\]) administered by intravenous drip infusion in participants with cardiac Fabry disease. Participants participated for 4 weeks or less in the baseline period and 156 weeks for the treatment period.
Timeline
- Start
- 2005-07
- Primary completion
- 2012-08
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | agalsidase beta | Protein / enzyme biologic | 1 mg/kg | Intravenous |