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Randomised, double-blind, placebo-controlled and parallel group trial to investigate the effects of one dose (up-titration to a fixed dose regimen) of oral BI 685509 on portal hypertension after 8 weeks treatment in patients with clinically significant portal hypertension (CSPH) in decompensated cirrhosis after their first decompensation event, who are stabilized CTP 5-7

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506083-13-00
Acronym
1366-0055
Enrollment
22
Registered
2023-11-22
Start date
2024-02-16
Completion date
2024-05-02
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

clinically significant portal hypertension (CSPH) in decompensated cirrhosis due to non-cholestatic liver disease

Brief summary

Percentage change in HVPG from baseline (measured in mmHg) after 8 weeks of treatment

Detailed description

Occurrence of a response, which is defined as >10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment, Occurrence of further decompensation events (i.e. ascites, VH, and / or overt HE) during the 8-week treatment period, Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8-week treatment period, Occurrence of discontinuation due to hypotension or syncope during the 8-week treatment period

Interventions

DRUGBI 685509
DRUGPlacebo matching BI 685509 PRD9566383
DRUGPlacebo matching BI 685509 PRD9566375
DRUGPlacebo matching BI 685509 PRD9566374

Sponsors

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage change in HVPG from baseline (measured in mmHg) after 8 weeks of treatment—

Secondary

MeasureTime frame
Occurrence of a response, which is defined as >10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment, Occurrence of further decompensation events (i.e. ascites, VH, and / or overt HE) during the 8-week treatment period, Occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8-week treatment period, Occurrence of discontinuation due to hypotension or syncope during the 8-week treatment period—

Countries

Austria, France, Germany, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026