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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT06082843
Other study ID # 1366-0055
Secondary ID 2023-506083-13-0
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 3, 2024
Est. completion date May 30, 2024

Study information

Verified date June 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 if they have high blood pressure in the portal vein (main vessel going to the liver) and bleeding in the esophagus or fluid accumulation in the belly. The purpose of this study is to find out whether a medicine called avenciguat helps people with this condition. Participants are put into 2 groups by chance. One group takes avenciguat tablets and the other group takes placebo tablets. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants take a tablet twice a day for 8 weeks. Participants are in the study for 2 to 3 months. During this time, they visit the study site regularly. At 2 of the visits, the doctors check the pressure in the liver vein by inserting a catheter (a long thin tube) that gives information about pressure in the portal vein. The change in blood pressure is then compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.


Recruitment information / eligibility

Status Terminated
Enrollment 22
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo matching Avenciguat (BI 685509)
Avenciguat (BI 685509)
Avenciguat (BI 685509)

Locations

Country Name City State
Austria AKH - Medical University of Vienna Vienna
Canada Centre Hospitalier de l'Universite de Montreal (CHUM) Montreal Quebec
China Beijing Friendship Hospital Beijing
China NanFang Hosptial Guangzhou
France HOP Beaujon Clichy
France HOP Rangueil Toulouse
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz
Germany Universitätsklinikum Münster Münster
Japan Shin-yurigaoka General Hospital Kanagawa, Kawasaki
Japan National Hospital Organization Yokohama Medical Center Kanagawa, Yokohama
Japan Yokohama City University Hospital Kanagawa, Yokohama
Japan Osaka Metropolitan University Hospital Osaka, Osaka
Korea, Republic of Soon Chun Hyang University Hospital Bucheon Bucheon-si, Gyeonggi-do
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju-si, Gangwon State
Romania Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor" Cluj-Napoca
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Puerta de Hierro Majadahonda
United States Northwell Health Center for Liver Disease Manhasset New York
United States California Liver Research Institute Pasadena California
United States Inland Empire Clinical Trials, LLC Rialto California

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Canada,  China,  France,  Germany,  Japan,  Korea, Republic of,  Romania,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage change in HVPG from baseline measured after 8 weeks of treatment Hepatic Venous Pressure Gradient (HVPG) measured in mmHg Up to 8 weeks
Secondary Occurrence of a response, which is defined as > 10% reduction from baseline HVPG after 8 weeks of treatment HVPG measured in mmHg Up to 8 weeks
Secondary Occurrence of further decompensation events (i.e. ascites, variceal haemorrhage (VH), and / or overt hepatic encephalopathy (HE)) during the 8 week treatment period Up to 8 weeks
Secondary Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8 week treatment period Common Terminology Criteria for Adverse Events (CTCAE) Up to 8 weeks
Secondary Occurrence of discontinuation due to hypotension or syncope during the 8 week treatment period Up to 8 weeks
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