Status:
COMPLETED
A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease.
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Fabry Disease
Eligibility:
All Genders
Brief 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 "...
Detailed Description
Medical institutions or physicians will be asked to periodically complete the survey forms for all patients registered. Survey forms include baseline information available, and then data collected eve...
Eligibility Criteria
Inclusion
- Patients in Japan with the indication of "Fabry Disease" and for whom the usual dosage and administration is 1mg of agalsidase beta (recombinant) per 1 kg body weight each time, administered by intravenous infusion every 2 weeks
- Because the efficacy evaluation of enzyme replacement therapy with Fabrazyme \[agalsidase beta (recombinant form)\] will require the comparison of findings before and after the start of enzyme replacement therapy, the efficacy evaluation set will be defined as including patients using Fabrazyme \[agalsidase beta (recombinant form)\] for the first time in the post-marketing setting and those for whom it is possible to obtain retrospective data for before the start of enzyme replacement therapy.
Exclusion
- Patients registered in the post-marketing trials during the post-marketing clinical trial period.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00233870
Start Date
June 1 2004
End Date
March 1 2011
Last Update
May 8 2015
Active Locations (1)
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1
Tohoku University Hospital
Sendai, Japan, 980-8574