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)
- Conditions
- portal hypertensionMedDRA version: 20.1Level: PTClassification code 10036200Term: Portal hypertensionSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-005171-40-AT
- Lead Sponsor
- Boehringer-Ingelheim RCV GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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 < 150 x 109/L [150 x 103/µL], nodular liver surface on imaging or splenomegaly etc.) Diagnosis of NASH based on either
i. Current or historic histological diagnosis of NASH OR steatosis
OR
ii. Clinical diagnosis of NASH based on historic or current imaging diagnosis of fatty liver (Fibroscan, US, MRI, CT) AND at least 2 current or historic comorbidities of the metabolic syndrome (overweight/obesity, T2DM, hypertension, hyperlipidemia)
6. Willing and able to undergo HVPG measurements per protocol (based on Investigator judgement)
7. 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
8. If receiving treatment with NSBBs or carvedilol must be on a stable dose for at least 1 months prior to screening (Visit 1b), with no planned dose change throughout the trial
Further criteria apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 < 100 mmHg and DBP < 70 mmHg at screening (Visit 1a)
6. Model of End-stage Liver Disease (MELD) score of > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method