3型フォン・ヴィレブランド病患者におけるエミシズマブの有効性と安全性を評価する研究

基本情報

NCT ID

NCT06998524

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

75

治験依頼者名

Hoffmann-La Roche

概要

This is a Phase III, multicenter, open-label clinical study designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab prophylaxis in participants aged 1 month and above, who have been diagnosed with Type 3 von Willebrand disease (VWD). Participants on prior standard of care (SOC) on-demand therapy will be assessed via a randomized comparison (Arm A - emicizumab prophylaxis and Arm B - continuation of SOC on-demand therapy), while participants on prior SOC prophylactic therapy (Arm C - emicizumab prophylaxis) will be assessed via intra-participant analysis with data obtained from the preceding non-interventional study (NIS), WP45335 (NCT06883240).

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)