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.
- Portal Hypertension
- Liver Disease
1 Primary · 4 Secondary · Reporting Duration: Up to 8 weeks
Side Effects for
Awards & Highlights
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
80 Total Participants · 4 Treatment Groups
Primary Treatment: BI 685509 · No Placebo Group · Phase 2
Who is running the clinical trial?
Age 18 - 75 · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- 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.
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
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
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
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
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