At a glance
ClinicalIndex Comparison Record- ✓Successfully completed the prior double-blind AGAL-008-00 study (NCT00074984)
- ✕Unable to complete the prior AGAL-008-00 study
- ✕History of kidney transplantation or currently on dialysis
- ✕Diabetes mellitus or confounding renal disease
- ✕Clinically significant organic disease or unstable medical condition precluding participation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-Center, Open-Label Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease That Previously Participated in the AGAL-008-00 Study
In Brief
A Phase 4 clinical trial evaluating agalsidase beta for Fabry Disease. Completed, enrolled 67 participants across 25 sites in 6 countries.
Detailed Summary
People with Fabry Disease have an alteration in their genetic material (DNA) which causes a deficiency of the alpha-galactosidase A enzyme. Fabrazyme (agalsidase beta) is a drug that helps to break down and removes certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids 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 (globatriaosylceramide or GL-3) levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study analyzed the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease that previously participated in the AGAL-008-00 (NCT0074984) study.
Study Details
Timeline
Interventions
1.0 mg/kg every 2 weeks