Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00233870
Status:
COMPLETED
Last Update Posted:
2015-05-08
First Post:
2005-10-05
Brief Title:
A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Special Survey in Long-Term Use of Fabrazyme
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 every 6 months as available including demographic information concomitant medicationstherapy treatment record ECG Echocardiogram computed tomography scan magnetic resonance imaging CTMRI Fabry symptoms labs functional disorder blood concentration of GL-3 and anti-agalsidase beta antibody test IgE testing to survey whether the productions of antibodies to agalsidase beta is a causal factor of treatment-related reactions
The survey period shall be approximately 7 years from June 1 2004 during which survey shall be undertaken as follows
The observation period for each patient shall range from 1 to about 7 years after starting treatment
Registration period June 1 2004 to March 31 2010
Survey period June 1 2004 to March 31 2011
In institutions for which retrospective surveys are feasible the survey period will trace back to the date of approval January 29 2004 as far as possible
The survey period shall be approximately 7 years from June 1 2004 during which survey shall be undertaken as follows
The observation period for each patient shall range from 1 to about 7 years after starting treatment
Registration period June 1 2004 to March 31 2010
Survey period June 1 2004 to March 31 2011
In institutions for which retrospective surveys are feasible the survey period will trace back to the date of approval January 29 2004 as far as possible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None