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インヒビターの有無にかかわらず、血友病Aの成人および青年におけるMim8を調査する研究

基本情報

NCT ID
NCT05053139
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
281
治験依頼者名
Novo Nordisk A/S

概要

This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

対象疾患

Haemophilia AHaemophilia A With Inhibitors

介入

NNC0365-3769 (Mim8)(DRUG)

依頼者(Sponsor)

実施施設 (10)

名古屋大学医学部附属病院

Aichi, Japan

静岡県立こども病院

Shizuoka, Japan

Jichi Medical University Hospital_Hematology

Tochigi, Japan

Tokyo Medical Univ. Hospital_Laboratory Medicine

Tokyo, Japan

医療法人財団 荻窪病院

Tokyo, Japan

独立行政法人労働者健康安全機構東北労災病院

Kitakyusyu-shi, Fukuoka, Japan

Jichi Medical University Hospital_Pediatrics

Tochigi, Japan

Nanbu Medical Center & Children's Medical Center

Okinawa, Japan

国立研究開発法人国立成育医療研究センター

Tokyo, Japan

医療法人財団徳禮会やすらぎの森診療所

Saitama, Japan