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BI 685509 + Empagliflozin 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

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)

Documented endoscopic-treated oesophageal varices as preventative treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

Study Summary

This trial is for adults with liver cirrhosis caused by hepatitis B, hepatitis C, or nonalcoholic steatohepatitis. The study is testing whether BI 685509, taken alone or with empagliflozin, helps people with this condition by checking the pressure in a liver vein.

Who is the study for?

Adults aged 18-75 with liver cirrhosis due to hepatitis B, C or NASH who have high blood pressure in the portal vein can join. They must consent to the trial, have documented varices, stable medication doses if on statins or beta-blockers, and be able to undergo specific liver vein pressure tests.Check my eligibility

What is being tested?

The study is testing BI 685509 alone or combined with Empagliflozin for treating high portal vein blood pressure in cirrhosis patients. Participants take BI 685509 tablets twice daily for eight weeks; some also take Empagliflozin once daily. The treatment's effect is monitored through regular health checks and measuring liver vein pressure.See study design

What are the potential side effects?

Potential side effects are not detailed here but typically could include gastrointestinal issues, changes in blood sugar levels (for those taking Empagliflozin), potential kidney function impact, allergic reactions, and other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have had a procedure to prevent bleeding from enlarged veins in my esophagus.

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 Hepatic Venous Pressure Gradient (HVPG) from baseline

Secondary outcome measures

Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 (or higher) hypotension or syncope based on Investigator judgement

Occurrence of a response

Occurrence of discontinuation due to hypotension or syncope

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Avenciguat (BI 685509) NASH treatment groupExperimental Treatment1 Intervention

Non-Alcoholic Steatohepatitis (NASH)

Group II: Avenciguat (BI 685509) HCV treatment groupExperimental Treatment1 Intervention

Hepatitis C Virus (HCV)

Group III: Avenciguat (BI 685509) HBV treatment groupExperimental Treatment1 Intervention

Hepatitis B Virus (HBV)

Group IV: Avenciguat (BI 685509) + empagliflozin NASH treatment groupExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin

2017

Completed Phase 4

~181750

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,506 Previous Clinical Trials

11,340,475 Total Patients Enrolled

Media Library

BI 685509 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05282121 — Phase 2

Liver Disease Research Study Groups: Avenciguat (BI 685509) HBV treatment group, Avenciguat (BI 685509) HCV treatment group, Avenciguat (BI 685509) + empagliflozin NASH treatment group, Avenciguat (BI 685509) NASH treatment group

Liver Disease Clinical Trial 2023: BI 685509 Highlights & Side Effects. Trial Name: NCT05282121 — Phase 2

BI 685509 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05282121 — Phase 2

Frequently Asked Questions

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

What hazards may be associated with BI 685509 administration?

"BI 685509's safety has been preliminarily ascertained, which is reflected in its score of 2 on our internal rating system. This medication is partaking in Phase 2 trials at the moment; while there are some data indicating a degree of security, none attest to its efficacy."

Answered by AI

Is this research endeavor presently seeking participants?

"Affirmative. The clinical trial registry states that this experiment is presently seeking participants; it was initially announced on May 26th 2022 and its details were refreshed as recently as November 28th 2022. It needs to recruit 80 patients from 3 distinct medical facilities."

Answered by AI

Who is eligible to participate in this trial?

"This clinical trial is recruiting 80 individuals, aged between 18-75 years old and suffering from hypertension portal. To be considered as eligible, the candidate must provide written informed consent according to ICH-GCP regulations in their country of residence; they should have a gastroscopy within 3 months prior to screening (Visit 1b); endoscopic proof of oesophageal/gastric varices at screening or before it; HVPG measured at Visit 1c being ≥ 10 mmHg; diagnosis of cirrhosis due to Hepatitis c virus (HCV), Hepatitis b virus (HBV) or"

Answered by AI

Does the eligibility for this trial encompass individuals over twenty years of age?

"This clinical trial mandates that potential participants must be at least 18 years of age, with the upper limit set to 75."

Answered by AI

How many individuals have enrolled in the experiment?

"This clinical trial, sponsored by Boehringer Ingelheim, requires 80 individuals who meet its inclusion criteria. Inland Empire Clinical Trials LLC in Rialto, California and CHUM Centre de recherche in Montreal are two of the sites where this research will be conducted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)

2022. "A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05282121.

All > Liver Disease > Cirrhosis