Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease

PHASE4CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

December 31, 2001

Study Completion Date

February 28, 2007

Conditions
Gaucher Disease, Type 1Cerebroside Lipidosis SyndromeGlucocerebrosidase Deficiency DiseaseGlucosylceramide Beta-Glucosidase Deficiency DiseaseGaucher Disease, Non-Neuronopathic Form
Interventions
DRUG

Cerezyme

Cerezyme doses of 20-60U/kg every 2 weeks (Q2 Arm) or 40-120 U/kg every 4 weeks (Q4 Arm).

Trial Locations (26)

10016

New York University, New York

10029

Mt. Sinai Medical Center, New York

12110

New York Oncology/Hematology PC, Latham

14215

Hemophilia Center of Western New York, Buffalo

15261

University of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

20211

Estadual de Hematologia Arthur de Siqueira Cavalcanti (HEMORIO), Rio de Janeiro

27710

Duke University Medical Center, Durham

30322

Emory University, Atlanta

33065

University Research Foundation for Lysosomal Storage Disease, Inc., Coral Springs

34137

Istituto per l'Infanzia Burlo-Garofolo, Trieste

45229

Children's Hospital Research Foundation, Cincinnati

60076

Midwest Cancer Research Group, Inc., Skokie

60614

Children's Memorial Hospital, Chicago

80131

"Universita degli Studi di Napoli Federico II", Naples

84132

University of Utah, Salt Lake City

97239

Oregon Health & Science University, Portland

02114

Massachusetts General Hospital, Boston

08903

Institute for Genetics Medicine Saint Peter's University Hospital, New Brunswick

07666

Holy Name Hospital, Teaneck

ON M5G 1X5

Mount Sinai Hospital, Toronto

Unknown

Istituto Giannina Gaslini, Genova

04-736

Instytut Pomnik Centrum Zdrowia Dzeicka, Warsaw

08035

Hospital Vall d´Hebrón, Barcelona

NW3 2QG

Royal Free Hospital, London

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00364858 - Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease | Biotech Hunter | Biotech Hunter