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BI 685509 for Portal Hypertension

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

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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 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 more

Trial 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,794 Total Patients Enrolled

Media Library

BI 685509 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05161481 — Phase 2

Portal Hypertension Research Study Groups: Avenciguat (BI 685509), dose group 2, Avenciguat (BI 685509), dose group 1, Placebo

Portal Hypertension Clinical Trial 2023: BI 685509 Highlights & Side Effects. Trial Name: NCT05161481 — Phase 2

BI 685509 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05161481 — Phase 2

Frequently Asked Questions

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

Does this trial require participants to be above a certain age?

"According to the age requirements set out in the inclusion criteria, patients must be between 18 and 75 years old to participate."

Answered by AI

Can new patients still join the trial?

"Yes, as can be seen from the clinicaltrials.gov listing, this research is looking for participants. The trial was first advertised on February 3rd, 2022 and has since been updated on November 14th of the same year."

Answered by AI

What sorts of risks are associated with BI 685509?

"BI 685509 has not been proven effective yet, but there is some evidence that it is safe. Our team rates it as a 2."

Answered by AI

How many patients are enrolled in this clinical trial?

"In order to fill the requirements of this study, we need 150 patients that meet the specified inclusion criteria. These patients can come from different locations such as California Liver Research Institute in Pasadena, Texas and American Research Corporation at the Texas Liver Institute in San Antonio, Quebec."

Answered by AI

Which patients would be a good match for this type of research?

"To be eligible for this hypertension study, portal vein patients must between 18-75 years old. The trial will have a total of 150 participants."

Answered by AI

Is this clinical trial widely available in Canada?

"There are a total of 8 clinical trial sites, with 4 being in North America: California Liver Research Institute (Pasadena), American Research Corporation (Texas Liver Institute, San Antonio), CHUM Centre de recherche (Montreal)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Live

2022. "A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Live". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05161481.

All > Blood Pressure > Cirrhosis