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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights
Study Summary
This trial is testing whether a medicine called BI 685509 can help people with liver cirrhosis and high blood pressure in the portal vein. People are randomly put into 3 groups, taking BI 685509 or placebo tablets twice a day for 8 months. The study measures the change in blood pressure to see if the treatment is effective.
Who is the study for?
Adults aged 18-75 with compensated alcohol-related liver cirrhosis and clinically significant portal hypertension can join. They must not have severe liver impairment, history of other chronic liver diseases, or recent treatments for Hepatitis C without sustained response. Participants should be able to undergo specific vein pressure measurements and abstain from significant alcohol use.Check my eligibility
What is being tested?
The trial is testing the effectiveness of BI 685509 in treating high blood pressure in the portal vein due to liver cirrhosis. Participants are randomly assigned to receive either one of two different doses of BI 685509 or a placebo, all taken as tablets twice daily over approximately eight months.See study design
What are the potential side effects?
While specific side effects for BI 685509 aren't listed here, participants' health will be monitored regularly for any unwanted effects which may include typical drug reactions such as digestive issues, headaches, fatigue, or potential liver-related complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have signed and understand the consent form for this trial.
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I am between 18 and 75 years old.
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I have been diagnosed with alcohol-related liver cirrhosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage change in Hepatic Venous Pressure Gradient (HVPG) from baseline (measured in mmHg) after 24 weeks of treatment
Secondary outcome measures
Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, 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 discontinuation due to hypotension or syncope during the 24 week treatment period
+5 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Avenciguat (BI 685509), dose group 2Experimental Treatment1 Intervention
Group II: Avenciguat (BI 685509), dose group 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,515 Previous Clinical Trials
11,347,210 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of chronic liver disease.You have not misused or abused alcohol for at least 2 months before the screening, and you can continue to abstain from alcohol during the trial as determined by the study doctor.I have been diagnosed with alcohol-related liver cirrhosis.I have been treated for hepatitis C with specific antiviral drugs within the last 2 years or will take them during the trial.I have signed and understand the consent form for this trial.You are able to have specific measurements taken as determined by the doctor.My liver function is impaired, with a score indicating moderate to severe issues.I show signs of significant liver blood pressure issues.I am between 18 and 75 years old.I have liver disease due to alcohol and haven't changed my lifestyle or still drink heavily.Your blood pressure is too low at the time of screening.I am willing to continue or start a therapy that may affect the trial's safety.I have had serious liver-related health events like fluid in the abdomen, bleeding varices, or brain fog due to liver issues.Your liver disease is very advanced, with a score higher than 15.I have been on a steady dose of statins or specific heart medications for 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Avenciguat (BI 685509), dose group 2
- Group 2: Avenciguat (BI 685509), dose group 1
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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