血友病B患者における凝固因子IXとアルブミンを連結した組換え融合タンパク質（rIX-FP）の安全性および有効性に関する延長試験

基本情報

NCT ID

NCT02053792

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

97

治験依頼者名

CSL Behring

概要

This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study. A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.

対象疾患

介入

依頼者（Sponsor）

実施施設 (7)