A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly
- Conditions
- Hypertension, PortalLiver Cirrhosis
- Registration Number
- NCT06082843
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria:<br><br> - Signed and dated written informed consent in accordance with International Council<br> for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to<br> admission to the trial<br><br> - Male or female who is =18 (or who is of legal age in countries where that is greater<br> than 18) and =75 years old at screening (Visit 1a)<br><br> - Diagnosis of cirrhosis due to non-cholestatic liver disease (including Hepatitis C<br> Virus (HCV), Hepatitis B Virus (HBV), Non-Alcoholic Steatohepatitis (NASH),<br> alcohol-related liver disease, autoimmune hepatitis, Wilson's disease,<br> haemachromatosis, alpha-1 antitrypsin (A1At) deficiency)<br><br> - One previous clinically significant decompensation event with clinical resolution at<br> least 4 weeks prior start of screening (visit 1a):<br><br> - First variceal haemorrhage<br><br> - First episode of clinically significant ascites (requiring intervention in<br> lifestyle [fluid and salt restriction] or medical treatment)<br><br> - Willing and able to undergo Hepatic Venous Pressure Gradient (HVPG) measurements per<br> protocol (based on Investigator judgement)<br><br> - If receiving statins must be on a stable dose for at least 3 months prior to<br> screening (Visit 1b), with no planned dose change throughout the trial<br><br> - If receiving treatment with Non-Selective Beta-Blocker (NSBBs) or carvedilol must be<br> on a stable dose for at least 1 month prior to screening (Visit 1b), with no planned<br> dose change throughout the trial<br><br> - For patient with alcohol-related cirrhosis, abstinence from significant alcohol<br> misuse / abuse for a minimum of 2 months prior to screening (Visit 1a), and the<br> ability to abstain from alcohol throughout the trial (both evaluated based on<br> Investigator judgement)<br><br>Further inclusion criteria apply<br><br>Exclusion Criteria:<br><br> - History of cholestatic chronic liver disease (e.g. primary biliary cholangitis,<br> primary sclerosing cholangitis)<br><br> - Trial participants without adequate treatment for HBV, HCV or NASH as per local<br> guidance (e.g. antiviral therapy for chronic HBV or HCV infection or lifestyle<br> modification in NASH)<br><br> - If received curative anti-viral therapy for Hepatitis C Virus (HCV), Sustained<br> Virological Response (SVR) sustained for less than 1 years prior to screening<br><br> - If receiving anti-viral therapy for HBV, less than 6 months on a stable dose prior<br> to screening, with planned dose change during the trial or HBV DNA detectable<br><br> - Weight change =5% within 6 months prior screening in patients with NASH<br><br> - 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> - Systolic Blood Pressure (SBP) <100 mmHg or Diastolic Blood Pressure (DBP) <70 mmHg<br> at screening (Visit 1a)<br><br> - Hepatic impairment defined as a Child-Turcotte-Pugh score =8 at screening<br><br>Further exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in HVPG from baseline measured after 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method Occurrence of a response, which is defined as > 10% reduction from baseline HVPG after 8 weeks of treatment;Occurrence of further decompensation events (i.e. ascites, variceal haemorrhage (VH), and / or overt hepatic encephalopathy (HE)) during the 8 week treatment period;Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8 week treatment period;Occurrence of discontinuation due to hypotension or syncope during the 8 week treatment period