日本人ファブリー病患者におけるファブラザイム補充療法の長期安全性および有効性に関する研究。

基本情報

NCT ID

NCT00233870

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

405

治験依頼者名

Sanofi

概要

The 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."

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)