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阻害因子を持たない重症血友病AおよびB患者におけるフィツシラン（ALN-AT3SC）の研究
基本情報
- NCT ID
- NCT03417245
- 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
- 120
- 治験依頼者名
- Sanofi
概要
Primary Objective: -To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by the frequency of bleeding episodes. Secondary Objectives: * To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by: * The frequency of spontaneous bleeding episodes. * The frequency of joint bleeding episodes. * Health-related quality of life (HRQOL) in participants \>=17 years of age. * To determine the frequency of bleeding episodes during the onset period. * To determine the safety and tolerability of fitusiran.
対象疾患
Hemophilia AHemophilia B
介入
fitusiran(DRUG)
factor concentrates(DRUG)
依頼者（Sponsor）
Genzyme, A Sanofi Company(INDUSTRY)