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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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19 October 2017 |
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Main ID: |
NCT00081497 |
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Date of registration:
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14/04/2004 |
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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 Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease
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Scientific title:
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Multi-Center, Open-Label Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease That Previously Participated in the AGAL-008-00 Study |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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67 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00081497 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Czech Republic
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Hungary
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Poland
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United Kingdom
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United States
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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 must have successfully completed the previous double-blind study AGAL-008-00
(NCT00074984)
- Patients must provide written informed consent prior to study participation
- Female patients of childbearing potential must have a negative pregnancy test prior to
each dosing and all female patients must use a medically accepted form of
contraception throughout the study
Exclusion Criteria:
- The patient was unable to complete AGAL-008-00 (NCT00074984)
- The patient has undergone kidney transplantation or is currently on dialysis
- The patient has diabetes mellitus or presence of confounding renal disease
- The patient has a clinically significant organic disease or an unstable condition that
precludes participation
- The patient is unwilling to comply with the protocol requirements
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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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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Biological: agalsidase beta
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Primary Outcome(s)
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Difference in Inverse Serum Creatinine Within Patients' Slopes Between the Placebo AGAL-008-00 (NCT00074984) and Fabrazyme AGAL02503 (NCT00081497) Periods
[Time Frame: Placebo period AGAL-008-00 (up to 35 months) through Fabrazyme period AGAL02503 (18 months)]
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Secondary Outcome(s)
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Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months
[Time Frame: Pre-Fabrazyme and 6, 12, and 18 months]
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Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months
[Time Frame: Pre-Fabrazyme, 6, 12, and 18 months]
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Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is = 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months
[Time Frame: Pre-Fabrazyme and 6, 12, and 18 months]
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Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months
[Time Frame: Pre-Fabrazyme, 6, 12, and 18 months]
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Secondary ID(s)
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AGAL02503
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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