BI 685509 for Portal Hypertension

Medizinische Hochschule Hannover, Hannover, Germany
Portal Hypertension+1 More ConditionsBI 685509 - Drug
Eligibility
18 - 75
All Sexes

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.

Eligible Conditions
  • Portal Hypertension
  • Liver Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 8 weeks

Week 8
Occurrence of a response
Percentage change in Hepatic Venous Pressure Gradient (HVPG) from baseline
Up to 8 weeks
Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 (or higher) hypotension or syncope based on Investigator judgement
Occurrence of discontinuation due to hypotension or syncope
Occurrence of one or more decompensation events

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Empagliflozin
12%Exacerbation of Heart Failure
9%Hypokalemia
9%Volume Depletion
6%Cough
6%Chest Pain
3%Hypotension
3%Pulmonary Nodule
3%Hematuria
3%Vertigo
3%Myocardial Infarction
3%Asymptomatic hypoglycemia
3%Lower left extremity swelling
3%Bronchitis
3%Cellulitis
3%Congestion
3%Head Contusion
3%Acute Kidney Injury
3%Increased craving for sweets
3%Esophagitis
3%Dysuria
3%Osteoarthritis - left knee
3%Vaginal Yeast Infection
3%Malaise
3%Wound Dehiscence
3%Cellulitis - bilateral legs
3%Concussion
3%Contusion - scalp
3%Gastritis
3%Exertional Angina
3%Gout Flare
3%Hiccups
3%Quick Tempered
3%Squamous cell carcinoma
3%Sepsis
3%Groin Abcess
3%Abscess - bilateral - hips, buttocks and upper legs
3%Gastroenteritis
3%Worsening Gout
3%Worsening Tricuspid Valve Regurgitation
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03030222) in the Empagliflozin ARM group. Side effects include: Exacerbation of Heart Failure with 12%, Hypokalemia with 9%, Volume Depletion with 9%, Cough with 6%, Chest Pain with 6%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

BI 685509 HBV treatment group
1 of 4
BI 685509 NASH treatment group
1 of 4
BI 685509 HCV treatment group
1 of 4
BI 685509 + empagliflozin NASH treatment group
1 of 4

Experimental Treatment

80 Total Participants · 4 Treatment Groups

Primary Treatment: BI 685509 · No Placebo Group · Phase 2

BI 685509 HBV treatment group
Drug
Experimental Group · 1 Intervention: BI 685509 · Intervention Types: Drug
BI 685509 NASH treatment group
Drug
Experimental Group · 1 Intervention: BI 685509 · Intervention Types: Drug
BI 685509 HCV treatment group
Drug
Experimental Group · 1 Intervention: BI 685509 · Intervention Types: Drug
BI 685509 + empagliflozin NASH treatment groupExperimental Group · 2 Interventions: BI 685509, Empagliflozin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 685509
2017
Completed Phase 2
~530
Empagliflozin
2017
Completed Phase 4
~102500

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 8 weeks

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,422 Previous Clinical Trials
10,238,779 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
There are additional requirements that need to be met to be included in the study.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.