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| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00364858 |
Purpose
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 |
|---|---|---|
|
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 95 |
| Study Start Date: | December 2001 |
| Study Completion Date: | February 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Q2 Cerezyme
Patients receiving Cerezyme one infusion every 2 weeks (Q2).
|
Drug: Cerezyme
Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).
|
|
Q4 Cerezyme
Patients receiving Cerezyme one infusion every 4 weeks (Q4).
|
Drug: Cerezyme
Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 26 Study Locations| Study Director: | Edward Kaye, M.D. | Genzyme |
More Information
| Responsible Party: | Medical Monitor, Genzyme Coporation |
| ClinicalTrials.gov Identifier: | NCT00364858 History of Changes |
| Other Study ID Numbers: | CZ-011-01 |
| Study First Received: | August 15, 2006 |
| Results First Received: | May 28, 2009 |
| Last Updated: | September 3, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Type 1 Gaucher Disease Glucocerebrosidase Deficiency Disease |
|
Deficiency Diseases Carbamoyl-Phosphate Synthase I Deficiency Disease Gaucher Disease Lipidoses Malnutrition Nutrition Disorders Urea Cycle Disorders, Inborn Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Amino Acid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Mitochondrial Diseases Sphingolipidoses Lysosomal Storage Diseases, Nervous System Lipid Metabolism, Inborn Errors Lysosomal Storage Diseases Lipid Metabolism Disorders |