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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
one film-coated tablet orally twice a day, at least 10 hours apart. The starting dose (1 mg) was up-titrated up to 3 mg
one 10 mg film-coated tablet of orally once a day
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
Percentage Change in HVPG From Baseline (Measured in mmHg) After 8 Weeks of Treatment
Percentage change in Hepatic Venous Pressure Gradient (HVPG) from baseline (measured in millimetre of mercury \[mmHg\]) after 8 weeks of treatment is reported. Adjusted mean (Least Square Mean) was calculated using an analysis of covariance (ANCOVA) model without imputing the missing data. The model included treatment as fixed classification effects, and baseline HVPG as a linear covariate. The random error was assumed to be normally distributed with mean 0 and variance σ².
Time frame: Before the first intake of trial medication (baseline), and after 8 weeks of treatment.
Occurrence of a Response, Which is Defined as > 10% Reduction From Baseline HVPG (Measured in mmHg) After 8 Weeks of Treatment
Occurrence of a response, which is defined as \> 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment is reported.
Time frame: Before the first intake of trial medication (baseline), and after 8 weeks of treatment.
Occurrence of One or More Decompensation Events (i.e. Ascites, VH, and / or Overt HE) During the 8-week Treatment Period
Occurrence of one or more decompensation events (i.e. ascites, Variceal Haemorrhage \[VH\], and / or overt Hepatic Encephalopathy \[HE\]) during the 8-week treatment period is reported.
Time frame: From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks.
Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement, During the 8-week Treatment Period
Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8-week treatment period is reported. The CTCAE grades are: 1 (mild Adverse Event \[AE\]), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).
Time frame: From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks.
Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period
Occurrence of discontinuation of treatment with avenciguat due to hypotension or syncope during the 8-week treatment period is reported.
Time frame: From first intake of study medication, until last intake of study medication plus 7 days, up to approximately 10 weeks.
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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
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Beijing, China
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