正常なC1阻害因子（C1-INH）を有する非ヒスタミン性血管性浮腫の急性発作を予防するための、10代および成人を対象としたラナデルマブの研究

基本情報

NCT ID

NCT04206605

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

77

治験依頼者名

Takeda

概要

The main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH. Another aim is to check if they tolerate the repeated SC injections. Participants will receive a SC injection of lanadelumab every two weeks for 26 weeks. The first two doses of lanadelumab will be given at the study clinic. Once a participant (and/or parent/caregiver) has been appropriately trained, lanadelumab can be self-injected. Visits to the study clinic are planned for the first, third and fourth week and then every 4 weeks.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)