Trials / Completed
CompletedNCT00365131
A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 10 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Gaucher Disease Type I
- Cerebroside Lipidosis Syndrome
- Clucocerebrosidase Deficiency Disease
- Glucosylceramide Beta-Glucosidase Deficiency Disease
- Gaucher Disease, Non-Neuronopathic Form
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cerezyme (imiglucerase for injection) |
Timeline
- Start date
- 1997-12-01
- Completion
- 2004-07-01
- First posted
- 2006-08-17
- Last updated
- 2015-03-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00365131. Inclusion in this directory is not an endorsement.