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
介入
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