A study to test whether BI 685509 helps people with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver) who had bleeding in the esophagus or fluid accumulation in the belly

Phase 1

• Conditions: clinically significant portal hypertension (CSPH) in decompensated cirrhosis due to non-cholestatic liver disease; MedDRA version: 20.1Level: PTClassification code: 10036200Term: Portal hypertension Class: 100000004871; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-506083-13-00
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial, Men able to father a child and who have a female sexual partner of CBP, must use a condom with or without spermicide, or adopt complete sexual abstinence, or be vasectomised (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate), from the randomisation visit (Visit 2) until 7 days after the last treatment in this 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, Diagnosis of cirrhosis due to non-cholestatic liver disease (including HCV, HBV, NASH, alcohol-related liver disease, autoimmune hepatitis, Wilson’s disease, haemachromatosis, alpha-1 antitrypsin [A1At] deficiency), One previous clinically significant decompensation event with clinical resolution at least 4 weeks prior start of screening (visit 1a): a. First variceal haemorrhage b. First episode of clinically significant ascites (requiring intervention in lifestyle [fluid and salt restriction] or medical treatment), Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement), If receiving statins must be on a stable dose for at least 3 months prior to screening (Visit 1b), with no planned dose change throughout the trial, If receiving treatment with NSBBs or carvedilol must be on a stable dose for at least 1 month prior to screening (Visit 1b), with no planned dose change throughout the trial, For patient with alcohol-related cirrhosis, abstinence from significant alcohol misuse / abuse for a minimum of 2 months prior to screening (Visit 1a), and the ability to abstain from alcohol throughout the trial (both evaluated based on Investigator judgement), WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from the randomisation visit (Visit 2) until 7 days after the last treatment in this trial. The patient must agree to periodic pregnancy testing during participation in the trial

Exclusion Criteria

History of cholestatic chronic liver disease (e.g. primary biliary sclerosis, primary sclerosing cholangitis), ALT or AST >5 times upper limit of normal (ULN) at screening (Visit 1a), measured by the central laboratory, eGFR (CKD-EPI formula) < 20 mL/min/1.73 m2 at screening (Visit 1a), measured by the central laboratory, Platelet count <50x10^9/L, Further exclusion criteria apply., Trial participants without adequate treatment for HBV, HCV or NASH as per local guidance (e.g. antiviral therapy for chronic HBV or HCV infection or lifestyle modification in NASH), If received curative anti-viral therapy for HCV, SVR sustained for less than 1 years prior to screening, If receiving anti-viral therapy for HBV, less than 6 months on a stable dose prior to screening, with planned dose change during the trial or HBV DNA detectable, Weight change =5% within 6 months prior screening in patients with NASH, Must take, or wishes to continue the intake of, restricted concomitant therapy or any concomitant therapy considered likely (based on Investigator judgement) to interfere with the safe conduct of the trial, SBP <100 mmHg or DBP <70 mmHg at screening (Visit 1a), Hepatic impairment defined as a Child-Turcotte-Pugh score =8 at screening, Model of End-stage Liver Disease (MELD) score of >15 at screening (Visit 1a), calculated by the central laboratory

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified