Patients with CSPH in compensated alcohol-related cirrhosis
Conditions
Interventions
Other: Placebo
Drug: BI 685509
Sponsors
Kutsunai Mitsuru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male or female who is >= 18 (or who is of legal age in countries where that is greater than 18) and == 10 mmHg (measured at Visit 1c), based on a local interpretation of the pressure tracing diagnosis of compensated alcohol-related cirrhosis. Diagnosis must be based on histology (historical data is acceptable) or on clinical evidence of cirrhosis (e.g. platelet count < 150 x 109/L [150 x 103/microL], nodular liver surface on imaging or splenomegaly) abstinence from alcohol for a minimum of 6 months prior to screening (Visit 1a), which, based on Investigator judgement, can be maintained throughout the trial willing and able to undergo HVPG measurements per protocol (based on Investigator judgement) if receiving statins, NSBBs or carvedilol must be on a stable dose for at least 3 months prior to screening (Visit 1b), with no planned dose change throughout the trial
Exclusion criteria
Exclusion criteria: previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], VH and / or apparent HE) history of other forms of chronic liver disease(e.g. non-alcoholic steatohepatitis [NASH], Hepatitis B virus [HBV], untreated HCV, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilsons disease, haemachromatosis, alpha- 1 antitrypsin [A1At] deficiency) alcohol-related liver disease (ARLD) without adequate treatment (e.g. lifestyle modification) or with ongoing pathological drinking behaviour SBP 15 at screening (Visit 1a) hepatic impairment defined as a Child-Turcotte-Pugh score >= B8 at screening (Visit 1a) ALT or AST > 5 times upper limit of normal (ULN) at screening (Visit 1a) eGFR (CKD-EPI formula) 50 ng/mL (> 50 microg/L) at screening (Visit 1a) history of clinically relevant orthostatic hypotension, fainting spells or blackouts due to hypotension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in HVPG from baseline (measured in mmHg) after 24 weeks of treatment | — |
Countries
Argentina, Austria, Belgium, Canada, China, Croatia, Denmark, France, Germany, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, Portugal, Romania, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactNobuko Yamada
Boehringer Ingelheim
Outcome results
None listed