← Back to Search

Other

Avenciguat (BI 685509) for Liver Cirrhosis

Phase 2

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

Study Summary

This trial is looking for adults with advanced liver cirrhosis caused by various factors like hepatitis B, hepatitis C, alcohol-related liver disease, and others. Participants with high blood pressure in the portal vein

Who is the study for?

Adults aged 18-75 with advanced liver cirrhosis from hepatitis, alcohol, or other causes can join this study if they've had bleeding in the esophagus or belly fluid buildup due to high blood pressure in the portal vein. They must be able to undergo specific liver pressure tests and have been stable on certain medications for months.Check my eligibility

What is being tested?

The trial is testing Avenciguat tablets against placebo pills (no medicine) to see if they help with portal hypertension in liver cirrhosis patients. Participants are randomly assigned to one of these two groups and take the tablets twice daily for 8 weeks while their health is monitored.See study design

What are the potential side effects?

While not specified here, side effects could include typical drug reactions such as digestive issues, headaches, dizziness, potential liver function changes, and any unique effects related to Avenciguat which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

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 HVPG from baseline measured after 8 weeks of treatment

Secondary outcome measures

Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8 week treatment period

Occurrence of a response, which is defined as > 10% reduction from baseline HVPG after 8 weeks of treatment

Occurrence of discontinuation due to hypotension or syncope during the 8 week treatment period

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Group II: Avenciguat (BI 685509)Experimental Treatment1 Intervention

This trial contemplates a dose-titration period, depending on dose tolerability.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,867 Total Patients Enrolled

6 Trials studying Liver Cirrhosis

542 Patients Enrolled for Liver Cirrhosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants who are at least 20 years of age being sought for inclusion in this study?

"In order to be eligible for this study, participants must be at least 18 years old but no older than 75."

Answered by AI

Is the current medical investigation open for participation?

"Affirmative. The details on clinicaltrials.gov indicate that this particular research study is actively seeking participants. Originally uploaded on January 3rd, 2024, the latest update was made on February 19th of the same year. Recruitment aims to enroll 40 individuals from four different locations."

Answered by AI

Are there multiple medical facilities in North America conducting this research study?

"At present, enrollment is ongoing at 4 distinct locations including Guangzhou, Bucheon, and Wonju-si alongside additional sites. Opting for the nearest clinic is vital to reduce travel requirements when joining this study."

Answered by AI

What is the total number of individuals participating in this clinical study?

"Indeed, the details available on clinicaltrials.gov reveal that this particular research study is actively pursuing potential candidates. Originally uploaded on January 3rd, 2024 and most recently revised on February 19th, 2024, it aims to recruit a total of 40 individuals from four distinct locations."

Answered by AI

Has the FDA given its approval for Avenciguat (BI 685509)?

"The safety rating for Avenciguat (BI 685509) was determined to be a 2 by our team at Power, based on the ongoing Phase 2 trial. At this stage, there is existing data supporting its safety profile but not yet confirming efficacy."

Answered by AI

What criteria must individuals meet in order to be eligible for participation in this clinical study?

"Individuals aged between 18 and 75 with a diagnosis of liver cirrhosis are eligible for participation in this research. The study aims to enroll a total of 40 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06082843.

All > Liver Fibrosis > Cirrhosis