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Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Investigate the Effects of Two Doses (Up-titration to a Fixed Dose Regimen) of Oral BI 685509 on Portal Hypertension After 24 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis
This study is open to adults with liver cirrhosis and 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 helps people with this condition. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of Avenciguat as tablets twice a day. Participants in the placebo group take placebo as tablets twice a day. Placebo tablets look like Avenciguat tablets but do not contain any medicine. Participants are in the study for about 8 months. During this time, they visit the study site about 14 times. At 3 of the visits, the doctors check the pressure in a liver vein. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The change in blood pressure is then compared between the groups to see whether the treatment works. 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
Northwell Health Center for Liver Disease
Manhasset, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
Hospital Italiano de Buenos Aires
CABA, Argentina
Medical University of Innsbruck
Innsbruck, Austria
AKH - Medical University of Vienna
Vienna, Austria
Edegem - UNIV UZ Antwerpen
Edegem, Belgium
Start Date
April 27, 2022
Primary Completion Date
May 2, 2024
Completion Date
June 12, 2024
Last Updated
September 3, 2025
80
ACTUAL participants
Avenciguat (BI 685509)
DRUG
Placebo matching Avenciguat (BI 685509)
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT05282121
NCT05304455
Data Source & Attribution
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