血友病A患者におけるMim8の調査研究

基本情報

NCT ID

NCT04204408

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

275

治験依頼者名

Novo Nordisk A/S

概要

This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected with a thin needle in the skin of the stomach, using a pen-injector. The study will last for up to 44 months. It consists of a main phase (part 1 and part 2) and an extension phase. In part 1, participants will be injected only once with either Mim8 or a "dummy" medicine (placebo) - which one will be decided by chance. In part 2 and the extension phase participants will get an Mim8 injection weekly or monthly.

対象疾患

介入

依頼者（Sponsor）

実施施設 (3)