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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

A study to test whether two different doses of BI 685509 help people with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver)

Kutsunai Mitsuru

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Yamada Nobuko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Not Recruiting

Feb. 18, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

male or female who is >= 18 (or who is of legal age in countries where that is greater than 18) and =< 75 years old at screening (Visit 1a)
clinical signs of CSPH as described by either one of the points below:
documented endoscopic proof of oesophageal varices and / or gastric varices at screening (Visit 1b) or within 3 months prior to screening (Visit 1b)
documented endoscopic-treated oesophageal varices as preventative treatment
CSPH defined as baseline HVPG >= 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

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 < 100 mmHg and DBP < 70 mmHg at screening (Visit 1a)
Model of End-stage Liver Disease (MELD) score of >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) < 20 mL/min/1.73 m2 at screening (Visit 1a)
alpha-fetoprotein > 50 ng/mL (> 50 microg/L) at screening (Visit 1a)
history of clinically relevant orthostatic hypotension, fainting spells or blackouts due to hypotension

Both

Patients with CSPH in compensated alcohol-related cirrhosis

Other: Placebo

Drug: BI 685509

Percentage change in HVPG from baseline (measured in mmHg) after 24 weeks of treatment

+81-45-851-2621

Nov. 09, 2021

No

Argentina/Austria/Belgium/Canada/China/Croatia/Denmark/France/Germany/India/Israel/Italy/Korea, Republic of/Netherlands/Portugal/Romania/Singapore/Spain/Switzerland/Taiwan/United Kingdom/United States