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BI 1819479が特発性肺線維症(IPF)患者の肺機能を改善するかどうかを検証する研究

基本情報

NCT ID
NCT06335303
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
322
治験依頼者名
Boehringer Ingelheim

概要

This study is open to adults 40 years or older with idiopathic pulmonary fibrosis (IPF). People can join the study if they are not on any treatment for IPF are on stable treatment for at least 3 months before starting the study. The purpose of this study is to find out whether a medicine called BI 1819479 helps people with IPF. 3 different doses of BI 1819479 are tested in this study. Participants are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1819479. Participants in 1 group get placebo. Placebo tablets look like BI 1819479 tablets, but do not contain any medicine. Participants take the treatment for 6 months to 1 year. Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site between 10 and 12 times and get up to 11 phone calls from the site staff. At site visits doctors regularly perform breathing tests that measure how well the lungs are working. Researchers compare the results between participants who take BI 1819479 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects.

対象疾患

特発性肺線維症

介入

BI 1819479(DRUG)
Placebo matching BI 1819479(DRUG)

実施施設 (11)

福井大学医学部附属病院

Fukui, Yoshida-gun, Japan

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

九州大学病院

Fukuoka, Fukuoka, Japan

公立陶生病院

Aichi, Seto, Japan

徳島大学病院

Tokushima, Tokushima, Japan

神奈川県立循環器呼吸器病センター

Kanagawa, Yokohama, Japan

東邦大学医療センター大森病院

Tokyo, Ota-ku, Japan

浜松医科大学医学部附属病院

Shizuoka, Hamamatsu, Japan

杏林大学医学部付属病院

Tokyo, Mitaka, 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