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NCT00364858 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 95
- Enrollment target
NCT00364858 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 95 participants.
The verdict
NCT00364858, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 95 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cerezyme
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2001-12 |
| Est. Completion | 2007-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00364858
The ClinicalTrials.gov registry entry for NCT00364858 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cerezyme is the first listed.
NCT00364858 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00364858 about?
NCT00364858 is a clinical study titled "Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease". 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...
What is the current status of trial NCT00364858?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 95 participants. The study started on 2001-12. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00364858?
The interventions under investigation include: Cerezyme (DRUG).
Who is sponsoring clinical trial NCT00364858?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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