This study is open to adults with advanced liver cirrhosis caused by hepatitis B, hepatitis C, alcohol-related liver disease, non-alcoholic steatohepatitis or other causes. People can join the study if they have high blood pressure in the portal vein (main vessel going to the liver) and bleeding in the esophagus or fluid accumulation in the belly. The purpose of this study is to find out whether a medicine called avenciguat helps people with this condition. Participants are put into 2 groups by chance. One group takes avenciguat tablets and the other group takes placebo tablets. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants take a tablet twice a day for 8 weeks. Participants are in the study for 2 to 3 months. During this time, they visit the study site regularly. At 2 of the visits, the doctors check the pressure in the liver vein by inserting a catheter (a long thin tube) that gives information about pressure in the portal vein. The change in blood pressure is then compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Placebo-matching Avenciguat
1 millligram (mg), 2 mg, or 3 mg film-coated tablet
California Liver Research Institute
Pasadena, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
AKH - Medical University of Vienna
Vienna, Austria
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Beijing Friendship Hospital
Beijing, China
NanFang Hosptial
Guangzhou, China
HOP Beaujon
Clichy, France
HOP Rangueil
Toulouse, France
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Universitätsklinikum Münster
Münster, Germany
...and 5 more locations
Percentage Change in Hepatic Venous Pressure Gradient (HVPG) From Baseline (Measured in mmHg) After 8 Weeks of Treatment
Percentage change in hepatic venous pressure gradient (HVPG) from baseline to Week 8.
Time frame: At baseline and at Week 8.
Occurrence of a Response, Defined as >10% Reduction From Baseline Hepatic Venous Pressure Gradient (HVPG) (Measured in mmHg) After 8 Weeks of Treatment
Occurrence of a response, defined as at least a 10% reduction in the hepatic venous pressure gradient (HVPG) (measured in mmHg) after 8 weeks of treatment.
Time frame: At baseline and at Week 8.
Occurrence of Further Decompensation Events (Ascites, Variceal Hemorrhage (VH), and / or Overt Hepatic Encephalopathy (HE)) During the 8-week Treatment Period
Number of participants with at least one decompensation events. Ascites, variceal hemorrhage (VH), and hepatic encephalopathy were defined as further decompensations events. As the trial was discontinued prematurely and no patient completed the 8-week treatment period, the data presented reflects the actual on-treatment period.
Time frame: Up to 46 days.
Occurrence of CTCAE Grade 3 (or Higher) Hypotension or Syncope Based on Investigator Judgement During the 8-week Treatment Period
Number of participants with grade 3 or higher common terminology criteria for adverse events (CTCAE) hypotension or syncope base on the investigator judgment. As the trial was discontinued prematurely and no patient completed the 8-week treatment period, the data presented reflects the actual on-treatment period.
Time frame: Up to 46 days.
Occurrence of Discontinuation Due to Hypotension or Syncope During the 8-week Treatment Period
Number of participants that discontinued avenciguat due to hypotension or syncope. As the trial was discontinued prematurely and no patient completed the 8-week treatment period, the data presented reflects the actual on-treatment period.
Time frame: Up to 46 days.
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