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agalsidase beta

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

Ensayo de Sanofi en Fabry Disease (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

67

previstos

Centros

25

Fin del objetivo primario

sep 2005

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2004.

Qué mide

Difference in Inverse Serum Creatinine Within Patients' Slopes Between the Placebo AGAL-008-00 (NCT00074984) and Fabrazyme AGAL02503 (NCT00081497) Periods (Placebo period AGAL-008-00 (up to 35 months) through Fabrazyme period AGAL02503 (18 months)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPeople 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.

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Ficha completa en ClinicalTrials.gov (NCT00081497), actualizada en mar 2015.