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Randomised, Open-label and Parallel Group Trial to Investigate the Effects of Oral BI 685509 Alone or in Combination With Empagliflozin on Portal Hypertension After 8 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
California Liver Research Institute
Pasadena, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Floridian Clinical Research-Miami Lakes-68368
Miami Lakes, Florida, United States
American Research Corporation
San Antonio, Texas, United States
Hospital Britanico de Buenos Aires
CABA, Argentina
Hospital Italiano de Buenos Aires
CABA, Argentina
AKH - Medical University of Vienna
Vienna, Austria
Edegem - UNIV UZ Antwerpen
Edegem, Belgium
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Beijing Friendship Hospital
Beijing, China
Start Date
June 28, 2022
Primary Completion Date
April 23, 2024
Completion Date
June 7, 2024
Last Updated
September 4, 2025
90
ACTUAL participants
Avenciguat
DRUG
Empagliflozin
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT05264051
NCT06493773
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07150624