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Home > "A" Clinical Trials Conditions > A Study of the Safety and Efficacy of Fabrazyme in Patients with Fabry Disease  A Study of the Safety and Efficacy of Fabrazyme in Patients with Fabry Disease
A Study of the Safety and Efficacy of Fabrazyme in Patients with Fabry Disease
For Condition: Fabry Disease
Status: No longer recruiting
Sponsor(s): Genzyme ,
Synopsis: People with Fabry Disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and removes certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In Fabry disease, glycolpids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid (globtriaosylceramide or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study will test the safety and efficiacy of Fabrazyme in the treatment of patients with Fabry disease.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients must have successfully completed the previous double-blind study (AGAL-008-00) - Patients must provide written informed consent prior to study participation - Female patients of childbearing potential must have a negative pregnancy test prior to each dosing and all female patients must use a medically accepted form of contraception throughout the study Exclusion Criteria: - The patient was unable to complete AGAL-008-00 - The patient has undergone kidney transplantation or is currently on dialysis - The patient has diabetes mellitus or presence of confounding renal disease - The patient has a clinically significant organic disease or an unstable condition that precludes participation - The patient is unwilling to comply with the protocol requirements
Total Enrollment: 70
Location and Contact Information:
University of Kansas Medical Center
Kansas City, Kansas, 66160-7233
United States
Hope Hospital
Manchester, , M6 8HD
United Kingdom
Oncology Hematology Association
Coral Springs, Florida, 33065
United States
University of Rochester School of Medicine
Rochester, New York, 14642
United States
University of Connecticut Health Partners
West Hartford, Connecticut, 06119
United States
Klinika Chorob Metabolicznych Instytut
Warsaw, , 04-730
Poland
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
North York General Hospital
Toronto, Ontario, M2K 1E1
Canada
Gene Therapy Center - Department of Pediatrics and Institute of Human Genetics
Minneapolis, Minnesota, 55455
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Sopron Megyei Jogu Varos Erzsebet Korhaz
Sopron, , 9400
Hungary
Children's Hospital
Buffalo, New York, 14209
United States
University of Washington School of Medicine
Seattle, Washington, 98195
United States
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
University of San Francisco
San Francisco, California, 94143
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
United States
Children's Memorial Hospital
Chicago, Illinois, 60614
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Queen Elizabeth II Health Center
Halifax, Nova Scotia, B3H 1V8
Canada
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Additional Information:
Study ID Numbers: AGAL02503;
Study Start Date: January 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081497
Other Fabry Disease Studies:
1. A Study of Fabrazyme in Pediatric Patients with Fabry Disease
2. Registry of Fabry Disease - A Multicenter Observational Study
3. Data Collection in Women with Fabry Disease
4. PET Scans in Normal Volunteers and Patients with Fabry Disease
5. A Study of the Safety and Efficacy of Fabrazyme as Compared to Placebo in Patients with Advanced Fabry Disease
Related Studies:
Other Fabry Disease Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
A Study of the Safety and Efficacy of Fabrazyme in Patients with Fabry Disease
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