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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Clinical Success at Month 24/Discontinuation
Month 24 (or at time of discontinuation)
No
Edward Kaye, M.D.
Study Director
Genzyme
United States: Food and Drug Administration
CZ-011-01
NCT00364858
December 2001
February 2007
Name | Location |
---|---|
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Midwest Cancer Research Group, Inc. | Skokie, Illinois 60077 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
University of Utah | Salt Lake City, Utah |
Oregon Health & Science University | Portland, Oregon 97201 |
Duke University Medical Center | Durham, North Carolina 27710 |
Emory University | Atlanta, Georgia 30322 |
Children's Memorial Hospital | Chicago, Illinois 60614 |
New York University | New York, New York 10016 |
Mt. Sinai Medical Center | New York, New York 10029 |
Holy Name Hospital | Teaneck, New Jersey 07666 |
University Research Foundation for Lysosomal Storage Disease, Inc. | Coral Springs, Florida 33065 |
Institute for Genetics Medicine Saint Peter's University Hospital | New Brunswick, New Jersey 08903 |
Hemophilia Center of Western New York | Buffalo, New York 14215 |
New York Oncology/Hematology PC | Latham, New York 12110 |
Children's Hospital Research Foundation | Cincinnati, Ohio 45229 |