特発性肺線維症(IPF)患者におけるBI 1015550の12週間投与が肺機能に及ぼす影響を検証する研究
基本情報
- NCT ID
- NCT04419506
- 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
- 147
- 治験依頼者名
- Boehringer Ingelheim
概要
This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. People taking standard medicines for IPF, including antifibrotic medicines, can continue taking them throughout the study. The purpose of the study is to find out whether a medicine called BI 1015550 can slow down the worsening of lung function. Participants are in the study for about 4 months. During this time, they visit the study site about 7 times. At the beginning, they visit the study site every 2 weeks. After 1 month of treatment, they visit the study site every 4 weeks. The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The participants take BI 1015550 or placebo tablets twice a day. The participants have lung function tests at study visits. The results of the lung function tests are compared between the BI 1015550 group and the placebo group. The doctors also regularly check the general health of the participants.
対象疾患
介入
依頼者(Sponsor)
実施施設 (6)
国立健康危機管理研究機構国立国際医療センター
Tokyo, Shinjuku-ku, Japan
独立行政法人国立病院機構 九州医療センター
Fukuoka, Fukuoka, Japan
公立陶生病院
Aichi, Seto, Japan
神奈川県立循環器呼吸器病センター
Kanagawa, Yokohama, Japan
浜松医科大学医学部附属病院
Shizuoka, Hamamatsu, Japan
独立行政法人国立病院機構 近畿中央呼吸器センター
Osaka, Sakai, Japan