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

  • STATUS
    Recruiting
  • End date
    Nov 10, 2023
  • participants needed
    150
  • sponsor
    Boehringer Ingelheim
Updated on 19 September 2022

Summary

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 BI 685509 helps people with this condition.

Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 685509 as tablets twice a day. Participants in the placebo group take placebo as tablets twice a day. Placebo tablets look like BI 685509 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.

Details
Condition Hypertension, Portal
Treatment BI 685509, Placebo matching BI 685509
Clinical Study IdentifierNCT05161481
SponsorBoehringer Ingelheim
Last Modified on19 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
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
Clinical signs of Clinically Significant Portal Hypertension (CSPH) as described by either one of the points below. Each trial patient must have a gastroscopy during the screening period or within 3 months prior to screening
documented endoscopic proof of oesophageal varices and / or gastric varices at screening or within 3 months prior to screening
documented endoscopic-treated oesophageal varices as preventative treatment
CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) ≥ 10 mmHg, 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 10^9/L [150 x 10^3/µL], nodular liver surface on imaging or splenomegaly)
Abstinence from alcohol for a minimum of 6 months prior to screening, 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, Non-Selective Beta-Blockers (NSBBs) or carvedilol must be on a stable dose for at least 3 months prior to screening, with no planned dose change throughout the trial Further inclusion criteria apply

Exclusion Criteria

Previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], Variceal Haemorrhage (VH) and / or apparent Hepatic Encephalopathy (HE))
History of other forms of chronic liver disease (e.g. non-alcoholic steatohepatitis (NASH), Hepatitis B virus (HBV), untreated Hepatitis C Virus (HCV), autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's 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
Systolic Blood Pressure (SBP) < 100 mmHg and Diastolic Blood Pressure (DBP) < 70 mmHg at screening
Model of End-stage Liver Disease (MELD) score of > 15 at screening, calculated by the central laboratory
Hepatic impairment defined as a Child-Turcotte-Pugh score ≥ B8 at screening, calculated by the site, using central laboratory results
Alanine amino transferase (ALT) or Aspartate amino transferase (AST) > 5 times upper limit of normal (ULN) at screening
Estimated Glomerular Filtration Rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) < 20 mL/min/1.73 m2 at screening
alpha-fetoprotein > 50 ng/mL (> 50 μg/L) at screening
history of clinically relevant orthostatic hypotension, fainting spells or blackouts due to hypotension or of unknown origin (based on Investigator judgement) Further exclusion criteria apply
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