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Agalsidase beta

A Long Term Safety and Efficacy Study of Fabrazyme Replacement Therapy in Japanese Patients With Fabry Disease.

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

Fase

no aplica

Estado

Completado

Participantes

405

previstos

Centros

1

Fin del objetivo primario

mar 2011

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en jun 2004.

Qué mide

Change in blood GL-3 level (del registro, en inglés) (6 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this survey is to identify any concerns regarding the following efficacy and safety-related issues in clinical practice with the new drugs "Fabrazyme for intravenous infusion 5mg" and "Fabrazyme for intravenous infusion 35mg" and to confirm the safety of these products in long-term use in the clinical setting. 1. New adverse drug reactions (ADRs) that cannot be predicted from the Precautions (in particular, clinically significant ADRs) 2. The incidence of ADRs under the actual conditions of use of the drug 3. Causal factors that might potentially affect safety 4. Efficacy evaluation in long-term use This survey will be conducted in accordance with the approval condition established for Fabrazyme: "To conduct a special surveillance of Efficacy and Safety in long term treatment and Pediatric with the drug."

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Ficha completa en ClinicalTrials.gov (NCT00233870), actualizada en may 2015.