NNC6019-0001と呼ばれる新薬がどのように作用し、トランスサイレチン(TTR)アミロイドーシスによる心臓病患者にどれほど安全であるかを調査する研究
基本情報
- NCT ID
- NCT05442047
- 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
- 105
- 治験依頼者名
- Novo Nordisk A/S
概要
This study is testing a potential new medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis.The study will look at if this medicine can reduce the symptoms of a heart disease due to TTR amyloidosis, such as heart failure. Participants will either get NNC6019-0001 (apotential new medicine) or placebo (a medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting NNC6019-0001 is two times higher than getting placebo. NNC6019-0001 is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe yet. Participants will get an infusion of the study medicine 13 times, once every 4 weeks. The study will last for about 64 weeks after the first dose of medicine. Participants cannot participate in this study if they have a heart disease other than a heart disease due to TTR amyloidosis.
対象疾患
介入
依頼者(Sponsor)
実施施設 (8)
広島市医師会運営・安芸市民病院
Hiroshima, Japan
長崎大学病院
Nagasaki, Japan
産業医科大学病院
Fukuoka, Japan
信州大学医学部附属病院
Nagano, Japan
Shinshu University Hospital, Department of Neurology
Nagano, Japan
くまもと免疫統合医療クリニック
Kumamoto-shi, Kumamoto, Japan
広島大学病院
Hiroshima, Japan
岡山大学病院
Okayama-shi, Okayama, Japan