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NCT00365131 · ClinicalTrials.gov registry record · Phase 4
A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease.
A Phase 4 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00365131 is a Phase 4 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 40 participants.
The verdict
NCT00365131, a Phase 4 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating patients with skeletal manifestations secondary to Type I Gaucher disease. The study objective is to evaluate and quantify skeletal responses as compared to baseline in Type I gaucher disease patients receiving Cerezyme therapy for 48 months. Additional objectives were to assess the usefulness of various skeletal parameters, such as bone pain, bone crises, bone mineral density, and serum and urine bone markers, as indicative of treatment response and may be useful in dose management.
Interventions
- DRUG Cerezyme (imiglucerase for injection)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 1997-12 |
| Est. Completion | 2004-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00365131
The ClinicalTrials.gov registry entry for NCT00365131 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 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 (imiglucerase for injection) is the first listed.
NCT00365131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00365131 about?
NCT00365131 is a clinical study titled "A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease.". This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating patients with skeletal manifestations secondary to Type I Gaucher disease. The study objective is to evaluate and quantify skeletal responses as compared to baseline in Type I gaucher disease patients recei...
What is the current status of trial NCT00365131?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 1997-12. Estimated completion is 2004-07.
What interventions are being tested in trial NCT00365131?
The interventions under investigation include: Cerezyme (imiglucerase for injection) (DRUG).
Who is sponsoring clinical trial NCT00365131?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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