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
- Health Condition 1: K766- Portal hypertension
- Registration Number
- CTRI/2022/05/042403
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
1) 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
2) Male or female who is greater than or equal to 18 (or who is of legal age in countries where that is greater than 18) and less than or equal to 75 years old at screening
3) 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
4) Documented endoscopic proof of oesophageal varices and / or gastric varices at screening or within 3 months prior to screening
5) Documented endoscopic-treated oesophageal varices as preventative treatment
6) CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) greater than or equal to 10 mmHg, based on a local interpretation of the pressure tracing
7) 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 less than 150 x 10 9/L [150 x 10 3/µL], nodular liver surface on imaging or splenomegaly)
8) Abstinence from alcohol for a minimum of 2 months prior to screening, which, based on Investigator judgement, can be maintained throughout the trial (both evaluated based on Investigator judgement)
9) Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement)
10) 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
1) Previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], Variceal Haemorrhage (VH) and / or apparent Hepatic Encephalopathy (HE))
2) 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, Wilsons disease, haemachromatosis, alpha 1 antitrypsin (A1At) deficiency)
3) Alcohol Related Liver Disease (ARLD) without adequate treatment (e.g. lifestyle modification) or with ongoing pathological drinking behaviour (misuse or abuse based on Investigator judgement)
4) Systolic Blood Pressure (SBP) less than 100 mmHg and Diastolic Blood Pressure (DBP) less than 70 mmHg at screening
5) Model of End stage Liver Disease (MELD) score of greater than 15 at screening, calculated by the central laboratory
6) Hepatic impairment defined as a Child Turcotte Pugh score greater than or equal to B8 at screening, calculated by the site, using central laboratory results
7) Alanine amino transferase (ALT) or Aspartate amino transferase (AST) greater than 5 times upper limit of normal (ULN) at screening
8) Estimated Glomerular Filtration Rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) less than 20 mL/min/1.73 m2 at screening
9) Alpha fetoprotein greater than 50 ng/mL (greater than 50 µg/L) at screening
10) 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in Hepatic Venous Pressure Gradient (HVPG) from baseline (measured in mmHg) after 24 weeks of treatmentTimepoint: at baseline, at week 24
- Secondary Outcome Measures
Name Time Method