Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
NCT00705939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2018-10-04
Summary
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.
This is an extension trial to Study NCT00376168 and NCT00712348.
Conditions
- Gaucher Disease
Interventions
- DRUG
-
Taliglucerase alfa
Intravenous infusion every 2 weeks
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2012-05-31
- Completion
- 2013-08-31
Countries
- United States
- Australia
- Canada
- Chile
- Israel
- South Africa
- Spain
- United Kingdom
Study Locations
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