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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00364858 |
This is a multicenter, randomized trial to compare the safety and efficacy of two dosing frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated with Cerezyme®.
Approximately 90 patients will be randomized in a 2:1 (q4 : q2) ratio to one of two treatment arms at up to 26 study centers worldwide. Patients will continue to receive the same total 4-week dose that they were receiving prior to study enrollment, however, they will be randomized to receive either their total 4-week dose in two infusions, one infusion every 2 weeks or their total 4-week dose in one infusion every 4 weeks. The randomization scheme will ensure a 2:1 balance between the every 4-week versus every 2-week infusion groups, respectively.
Condition | Intervention | Phase |
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Gaucher Disease, Type 1 Cerebroside Lipidosis Syndrome Glucocerebrosidase Deficiency Disease Glucosylceramide Beta-Glucosidase Deficiency Disease Gaucher Disease, Non-Neuronopathic Form |
Drug: Cerezyme |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Multicenter, Randomized, Dose Frequency Study of the Safety and Efficacy of Cerezyme® Infusions Every Four Weeks Versus Every Two Weeks in the Maintenance Therapy of Patients With Type 1 Gaucher Disease |
Estimated Enrollment: | 90 |
Study Start Date: | December 2001 |
Study Completion Date: | February 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Edward Kaye, M.D. | Genzyme |
Study ID Numbers: | CZ-011-01 |
Study First Received: | August 15, 2006 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00364858 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Type 1 Gaucher Disease Glucocerebrosidase Deficiency Disease |
Lipid Metabolism, Inborn Errors Sphingolipidoses Metabolic Diseases Gaucher Disease Type 1 Lysosomal Storage Diseases Sphingolipidosis Central Nervous System Diseases Brain Diseases Lymphatic Diseases Metabolism, Inborn Errors |
Malnutrition Genetic Diseases, Inborn Nutrition Disorders Lipidoses Brain Diseases, Metabolic, Inborn Gaucher Disease Metabolic Disorder Lipid Metabolism Disorders Deficiency Diseases Brain Diseases, Metabolic |
Lipid Metabolism, Inborn Errors Sphingolipidoses Disease Metabolic Diseases Reticuloendotheliosis Lysosomal Storage Diseases, Nervous System Lysosomal Storage Diseases Nervous System Diseases Central Nervous System Diseases Brain Diseases Metabolism, Inborn Errors Lymphatic Diseases |
Pathologic Processes Malnutrition Genetic Diseases, Inborn Syndrome Nutrition Disorders Lipidoses Brain Diseases, Metabolic, Inborn Gaucher Disease Lipid Metabolism Disorders Deficiency Diseases Brain Diseases, Metabolic |