Status:
TERMINATED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension, Portal
Liver Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is open to adults with advanced liver cirrhosis caused by hepatitis B, hepatitis C, alcohol-related liver disease, non-alcoholic steatohepatitis or other causes. People can join the study i...
Eligibility Criteria
Inclusion
- Signed and dated written informed consent in accordance with International Council for 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 (Visit 1a)
- Diagnosis of cirrhosis due to non-cholestatic liver disease (including Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-Alcoholic Steatohepatitis (NASH), alcohol-related liver disease, autoimmune hepatitis, Wilson's disease, haemachromatosis, alpha-1 antitrypsin (A1At) deficiency)
- One previous clinically significant decompensation event with clinical resolution at least 4 weeks prior start of screening (visit 1a):
- First variceal haemorrhage
- First episode of clinically significant ascites (requiring intervention in lifestyle \[fluid and salt restriction\] or medical treatment)
- Willing and able to undergo Hepatic Venous Pressure Gradient (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 (Visit 1b), with no planned dose change throughout the trial
- If receiving treatment with Non-Selective Beta-Blocker (NSBBs) or carvedilol must be on a stable dose for at least 1 month prior to screening (Visit 1b), with no planned dose change throughout the trial
- For patient with alcohol-related cirrhosis, abstinence from significant alcohol misuse / abuse for a minimum of 2 months prior to screening (Visit 1a), and the ability to abstain from alcohol throughout the trial (both evaluated based on Investigator judgement)
- Further inclusion criteria apply
Exclusion
- History of cholestatic chronic liver disease (e.g. primary biliary cholangitis, primary sclerosing cholangitis)
- Trial participants without adequate treatment for HBV, HCV or NASH as per local guidance (e.g. antiviral therapy for chronic HBV or HCV infection or lifestyle modification in NASH)
- If received curative anti-viral therapy for Hepatitis C Virus (HCV), Sustained Virological Response (SVR) sustained for less than 1 years prior to screening
- If receiving anti-viral therapy for HBV, less than 6 months on a stable dose prior to screening, with planned dose change during the trial or HBV DNA detectable
- Weight change ≥5% within 6 months prior screening in patients with NASH
- 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
- Systolic Blood Pressure (SBP) \<100 mmHg or Diastolic Blood Pressure (DBP) \<70 mmHg at screening (Visit 1a)
- Hepatic impairment defined as a Child-Turcotte-Pugh score ≥8 at screening
- Further exclusion criteria apply
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06082843
Start Date
January 3 2024
End Date
May 30 2024
Last Update
June 12 2025
Active Locations (15)
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1
California Liver Research Institute
Pasadena, California, United States, 91105
2
Inland Empire Clinical Trials, LLC
Rialto, California, United States, 92377
3
AKH - Medical University of Vienna
Vienna, Austria, 1090
4
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0A9