A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease.
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this survey is to identify any concerns regarding the following efficacy and
safety-related issues in clinical practice with the new drugs "Fabrazyme for intravenous
infusion 5mg" and "Fabrazyme for intravenous infusion 35mg" and to confirm the safety of
these products in long-term use in the clinical setting.
1. New adverse drug reactions (ADRs) that cannot be predicted from the Precautions (in
particular, clinically significant ADRs)
2. The incidence of ADRs under the actual conditions of use of the drug
3. Causal factors that might potentially affect safety
4. Efficacy evaluation in long-term use
This survey will be conducted in accordance with the approval condition established for
Fabrazyme:
"To conduct a special surveillance of Efficacy and Safety in long term treatment and
Pediatric with the drug."