portal hypertension MedDRA version: 20.1 Level: PT Classification code 10036200 Term: Portal hypertension System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: BI 685509
Product Code: BI 685509
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: None yet
Other descriptive name: BI 685509
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Boehringer Ingelheim B. V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 2. 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) 3. Clinical signs of CSPH as described by either one of the points below. Each trial patient must have a gastroscopy during the screening period (Visit 1b) or within 6 months prior to screening (Visit 1b). - documented endoscopic proof of oesophageal varices and / or gastric varices at screening (Visit 1b) or within 6 months prior to screening (Visit 1b) - documented endoscopic-treated oesophageal varices as preventative treatment 4. CSPH defined as baseline HVPG = 10 mmHg (measured at Visit 1c), based on a local interpretation of the pressure tracing 5. Diagnosis of compensated cirrhosis due to HCV, HBV, or NASH with or without T2DM. Diagnosis of cirrhosis must be based on histology (historical data is acceptable) or on clinical evidence of cirrhosis (e.g. platelet count =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], VH and / or overt / apparent HE) 2. History of other forms of chronic liver disease (e.g. alcohol-related liver disease (ARLD), autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson’s disease, haemachromatosis, alpha-1 antitrypsin [A1At] deficiency) 3. Patients 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, no sustained virological response (SVR) or SVR sustained for less than 2 years prior to screening or if HCV RNA detectable - 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 4. 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 5. SBP 15 at screening (Visit 1a), calculated by the central laboratory 7. Hepatic impairment defined as a Child-Turcotte-Pugh score = B8 at screening (Visit 1a), calculated by the site, using central laboratory results 8. ALT or AST > 5 times upper limit of normal (ULN) at screening (Visit 1a), measured by the central laboratory Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial will investigate the safety and tolerability of BI 685509 in patients with CSPH in compensated cirrhosis due to HBV, HCV and NASH with or without T2DM and the combination of BI 685509 and empagliflozin in patients with CSPH in compensated cirrhosis due to NASH with T2DM, on top of standard of care respectively. The primary objective is to estimate the percentage change in HVPG from baseline measured after 8 weeks. The primary analysis will be made for treated patients with baseline HVPG measurements (Full Analysis Set, FAS) as if all patients took treatment for the duration of the trial.;Secondary Objective: Safety and tolerability will also be investigated.;Primary end point(s): 1) Percentage change in HVPG from baseline (measured in mmHg) after 8 weeks of treatment;Timepoint(s) of evaluation of this end point: 1) 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) occurrence of a response, which is defined as > 10% reduction from baseline HVPG (measured in mmHg) after 8 weeks of treatment 2) occurrence of one or more decompensation events (i.e. ascites, VH, and / or overt HE) during the 8-week treatment period 3) occurrence of CTCAE grade 3 (or higher) hypotension or syncope based on Investigator judgement, during the 8-week treatment period 4) occurrence of discontinuation due to hypotension or syncope during the 8-week treatment period;Timepoint(s) of evaluation of this end point: 1) 8 weeks 2) 8 weeks 3) 8 weeks 4) 8 weeks | — |
Countries
Argentina, Austria, Belgium, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Netherlands, Singapore, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed