BI 685509単独またはエンパグリフロジンとの併用が、門脈（肝臓につながる主要血管）の血圧が高いウイルス性肝炎または非アルコール性脂肪肝炎（NASH）に起因する肝硬変患者に効果があるかどうかを検証する研究

基本情報

NCT ID

NCT05282121

ステータス

中止

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

90

治験依頼者名

Boehringer Ingelheim

概要

This study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or nonalcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) taken alone or in combination with a medicine called empagliflozin helps people with this condition. Participants take Avenciguat (BI 685509) as tablets twice a day for 8 weeks. Half of the participants with NASH who also have type 2 diabetes take empagliflozin as tablets once a day in addition to Avenciguat (BI 685509). Participants are in the study for about 3 months. During this time, they visit the study site about 10 times. At 2 of the visits, the doctors check the pressure in a liver vein to see whether the treatment works. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The doctors also regularly check participants' health and take note of any unwanted effects.

対象疾患

介入

依頼者（Sponsor）

実施施設 (2)