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Tracking Information | |||||
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First Received Date † | August 15, 2006 | ||||
Last Updated Date | June 19, 2008 | ||||
Start Date † | December 2001 | ||||
Current Primary Outcome Measures † |
Assess the Safety and Efficacy of two different dosing frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated with Cerezyme®. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00364858 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Assess the Quality of life as measured by the SF-36 questionnaire. | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease | ||||
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 | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † |
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Intervention † | Drug: Cerezyme | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 90 | ||||
Completion Date | February 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Brazil, Canada, Italy, Poland, Spain, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00364858 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Genzyme | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Genzyme | ||||
Verification Date | February 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |