成人血友病B患者における現行のFIX補充療法（FIX:C≤2%）または成人血友病A患者における現行のFVIII補充療法（FVIII:C≤1%）の有効性および安全性データの前向き評価研究

基本情報

NCT ID

NCT03587116

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

212

治験依頼者名

Pfizer

概要

To establish baseline prospective efficacy data of current FIX prophylaxis replacement therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to AAV-Spark100, prior to the Phase 3 gene therapy study. To establish baseline prospective efficacy data of current FVIII prophylaxis replacement therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to AAV6, prior to the Phase 3 gene therapy study. The enrollment for hemophilia A participants is completed. At this time participants are only being enrolled for hemophilia B cohort.

対象疾患

介入

依頼者（Sponsor）

実施施設 (6)