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)
- Conditions
- portal hypertensionMedDRA version: 20.0Level: HLTClassification code 10036201Term: Portal hypertensionsSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-001285-38-IT
- Lead Sponsor
- BOEHRINGER-INGELHEIM ITALIA S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
- Signed and dated written informed consent in accordance with ICHGCP
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 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 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 109/L [150 x 103/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 must be on a stable dose for at least 3 months prior
to screening, with no planned dose change throughout the trial
- If receiving treatment with 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
- WOCBP must be ready and able to use highly effective methods of
birth control per ICH M3 (R2) that result in a low failure rate of less than
1% per year when used consistently and correctly from the
randomisation visit until 7 days after the last treatment in this trial. The
patient must agree to periodic pregnancy testing during participation in
the trial.
- Men able to father a child and who have a female sexual partner of
CBP, must use a condom with or without spermicide, or adopt complete
sexual abstinence, or be vasectomised (with appropriate post-vasectomy
documentation of the absence of sperm in the ejaculate), from the
randomisation visit until 7 days after the last treatment in this trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
- 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, Wilson's disease, haemachromatosis, alpha-1 antitrypsin
[A1At] deficiency)
- Has received curative anti-viral therapy with direct-acting anti-virals
within the last 2 years for HCV with a sustained virological response
(SVR) at screening and throughout the trial
- ARLD without adequate treatment (e.g. lifestyle modification) or with
ongoing pathological drinking behaviour
- Must take, or wishes to continue the intake of, restricted concomitant
therapy or any concomitant therapy considered likely (based on
Investigator judgement) to interfere with the safe conduct of the trial
- SBP < 100 mmHg and 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
- ALT or AST > 5 times upper limit of normal (ULN) at screening,
measured by the central laboratory
- eGFR (CKD-EPI formula) < 20 mL/min/1.73 m2 at screening, measured
by the central laboratory
- Alpha-fetoprotein > 50 ng/mL (> 50 µg/L) at screening, measured by
the central laboratory
- An active infection with SARS-CoV-2 (or who is known to have a
positive test from screening until randomisation)
- Prior orthotopic liver transplantation
- Prior or planned TIPS or other porto-systemic bypass procedure
- Known portal vein thrombosis
- History of clinically relevant orthostatic hypotension, fainting spells or
blackouts due to hypotension or of unknown origin (based on
Investigator judgement)
- Women who are pregnant, nursing, or who plan to become pregnant
whilst in the trial
- Further criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method