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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 May 2015 |
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Main ID: |
NCT00233870 |
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Date of registration:
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05/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease.
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Scientific title:
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Special Survey in Long-Term Use of Fabrazyme |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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405 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00233870 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genzyme, a Sanofi Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- Patients registered in the post-marketing trials during the post-marketing clinical
trial period.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fabry Disease
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Intervention(s)
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Drug: Agalsidase beta (recombinant form)
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Primary Outcome(s)
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Change in blood GL-3 level
[Time Frame: 6 months]
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Secondary ID(s)
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AGAL03004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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