A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Live
- Conditions
- Hypertension, Portal
- Registration Number
- NCT05161481
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria:<br><br> 1. Signed and dated written informed consent in accordance with International Council<br> on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to<br> admission to the trial<br><br> 2. Male or female who is = 18 (or who is of legal age in countries where that is<br> greater than 18) and = 75 years old at screening<br><br> 3. Clinical signs of Clinically Significant Portal Hypertension (CSPH) as described by<br> either one of the points below. Each trial patient must have a gastroscopy during<br> the screening period or within 6 months prior to screening.<br><br> - documented endoscopic proof of oesophageal varices and / or gastric varices at<br> screening or within 6 months prior to screening<br><br> - documented endoscopic-treated oesophageal varices as preventative treatment<br><br> 4. CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) = 10 mmHg, based on<br> a local interpretation of the pressure tracing<br><br> 5. Diagnosis of compensated alcohol-related cirrhosis. Diagnosis must be based on<br> histology (historical data is acceptable) or on clinical evidence of cirrhosis (e.g.<br> platelet count < 150 x 10^9/L [150 x 10^3/µL], nodular liver surface on imaging or<br> splenomegaly)<br><br> 6. Abstinence from significant alcohol misuse / abuse for a minimum of 2 months prior<br> to screening, and the ability to abstain from alcohol throughout the trial (both<br> evaluated based on Investigator judgement)<br><br> 7. Willing and able to undergo HVPG measurements per protocol (based on Investigator<br> judgement)<br><br> 8. If receiving statins must be on a stable dose for at least 3 months prior to<br> screening, with no planned dose change throughout the trial Further inclusion<br> criteria apply.<br><br>Exclusion Criteria:<br><br> 1. Previous clinically significant decompensation events (e.g. ascites [more than<br> perihepatic ascites], Variceal Haemorrhage (VH) and / or apparent Hepatic<br> Encephalopathy (HE))<br><br> 2. History of other forms of chronic liver disease (e.g. non-alcoholic steatohepatitis<br> (NASH), Hepatitis B virus (HBV), untreated Hepatitis C Virus (HCV), autoimmune liver<br> disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's<br> disease, haemachromatosis, alpha-1 antitrypsin (A1At) deficiency)<br><br> 3. Has received curative anti-viral therapy with direct-acting anti-virals within the<br> last 2 years for HCV, or, if such treatment was > 2 years ago and there is no<br> sustained virological response (SVR) at screening, or, must take curative anti-viral<br> therapy with direct-acting anti-virals throughout the trial<br><br> 4. Alcohol-Related Liver Disease (ARLD) without adequate treatment (e.g. lifestyle<br> modification) or with ongoing pathological drinking behaviour (misuse / abuse based<br> on Investigator judgement)<br><br> 5. Must take, or wishes to continue the intake of, restricted concomitant therapy or<br> any concomitant therapy considered likely (based on Investigator judgement) to<br> interfere with the safe conduct of the trial<br><br> 6. Systolic Blood Pressure (SBP) < 100 mmHg and Diastolic Blood Pressure (DBP) < 70<br> mmHg at screening<br><br> 7. Model of End-stage Liver Disease (MELD) score of > 15 at screening, calculated by<br> the central laboratory<br><br> 8. Hepatic impairment defined as a Child-Turcotte-Pugh score = B8 at screening,<br> calculated by the site, using central laboratory results Further exclusion criteria<br> apply.
Not provided
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 treatment
- Secondary Outcome Measures
Name Time Method Percentage change in HVPG from baseline (measured in mmHg) after 8 weeks of treatment;Response defined as > 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment;Response defined as > 10% reduction from baseline HVPG (measured in mmHg) after 24 weeks of treatment;Occurrence of one or more decompensation events (i.e. ascites, Variceal Haemorrhage (VH), and/or overt Hepatic Encephalopathy (HE)) during the 24 week treatment period;Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the first 8 weeks of the treatment period;Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 24 week treatment period;Occurrence of discontinuation due to hypotension or syncope during the first 8 weeks of the treatment period;Occurrence of discontinuation due to hypotension or syncope during the 24 week treatment period