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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00140621 |
This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of Fabrazyme [agalsidase beta (recombinant form)] administered by intravenous drip infusion in patients with cardiac Fabry disease.
Patients will participate for 4 weeks or less in the baseline period and 156 weeks for the treatment period.
Primary evaluation variables that will be explored:
Secondary evaluation variables that will be explored:
Adverse events, vital signs, head magnetic resonance imaging (MRI), clinical laboratory data, and immunogenicity will also be explored.
Condition | Intervention | Phase |
---|---|---|
Fabry Disease |
Drug: Agalsidase beta (Fabrazyme) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Open-Label Study of the Safety and Efficacy of a-Galactosidase A (r-h a-GAL) Replacement Therapy in Patients With Cardiac Fabry Disease |
Estimated Enrollment: | 6 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | March 2011 |
Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients definitively diagnosed with cardiac Fabry disease (who fulfill all of the following criteria):
Exclusion Criteria:
Contact: Clinical Division Genzyme K.K. | 81-3-3230-8285 |
Japan | |
Kagoshima University Hospital | Recruiting |
Kagoshima, Japan, 890-8520 | |
Principal Investigator: Shuichi Hamasaki, M.D., Ph.D. | |
Uwajima City Hospital | Recruiting |
Ehime, Japan, 798-8510 | |
Principal Investigator: Mareomi Hamada, M.D., Ph.D. | |
Fujita Health University Hospital | Recruiting |
Aichi, Japan, 470-1192 | |
Principal Investigator: Shin-ichiro Morimoto, M.D., Ph.D. | |
Yamanashi Prefectural central Hospital | Recruiting |
Yamanashi, Japan, 400-8506 | |
Principal Investigator: Kazunori Aizawa, M.D., Ph.D. | |
Tohoku University Hospital | Recruiting |
Miyagi, Japan, 980-8574 | |
Principal Investigator: Hiroaki Shimokawa, M.D., Ph.D. |
Study Director: | Bernard Bénichou, M.D., Ph.D. | Genzyme |
Study ID Numbers: | AGAL03204 |
Study First Received: | August 30, 2005 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00140621 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
cardiac fabry disease |
Lipid Metabolism, Inborn Errors Sphingolipidoses Metabolic Diseases Lysosomal Storage Diseases Fabry disease Sphingolipidosis Central Nervous System Diseases Brain Diseases Metabolism, Inborn Errors |
Ceramide trihexosidosis Genetic Diseases, Inborn Fabry Disease Genetic Diseases, X-Linked Brain Diseases, Metabolic, Inborn Lipidoses Metabolic disorder Lipid Metabolism Disorders Brain Diseases, Metabolic |
Lysosomal Storage Diseases, Nervous System Nervous System Diseases |