A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease

PHASE4CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

February 28, 2001

Primary Completion Date

January 31, 2004

Study Completion Date

January 31, 2004

Conditions
Fabry Disease
Interventions
BIOLOGICAL

Fabrazyme (agalsidase beta)

1mg/kg Fabrazyme (agalsidase beta) every 2 weeks

BIOLOGICAL

Placebo

1 mg/kg placebo intravenously every 2 weeks

Trial Locations (26)

9400

Sopron Megyei Jogu Varos Erzsebet Korhaz, Sopron

10029

Mount Sinai School of Medicine, New York

14209

Children's Hospital, Buffalo

14642

University of Rochester School of Medicine, Rochester

15261

University of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

27710

Duke University Medical Center, Durham

30322

Emory University School of Medicine, Atlanta

33065

Oncology Hematology Association, Coral Springs

35294

University of Alabama at Birmingham, Birmingham

45229

Children's Hospital Medical Center, Cincinnati

55455

Gene Therapy Center - Dept. of Pediatrics and Institute of Human Genetics, Minneapolis

60614

Children's Memorial Hospital, Chicago

66160

University of Kansas Medical Center, Kansas City

77030

Baylor College of Medicine, Houston

90048

Cedars-Sinai Medical Center, Los Angeles

94143

University of San Francisco, San Francisco

98195

University of Washington School of Medicine, Seattle

06119

University of Connecticut Health Partners, Farmington

02114

Massachusetts General Hospital, Boston

B3H 1V8

Queen Elizabeth II Health Center, Halifax

M2K 1E1

North York General Hospital, Toronto

H4J 1C5

Hopital du Sacre-Coeur de Montreal, Montreal

128 08

University Hospital, Prague

04-730

Klinika Chorob Metabolicznych Instytut, Warsaw

M6 8HD

Hope Hospital, Manchester

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00074984 - A Study of the Safety and Efficacy of Fabrazyme (Agalsidase Beta) as Compared to Placebo in Patients With Advanced Fabry Disease | Biotech Hunter | Biotech Hunter