Phase
Condition
Vascular Diseases
Circulation Disorders
Stress
Treatment
Empagliflozin
BI 685509
Avenciguat (BI 685509)
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed and dated written informed consent in accordance with ICH-GCP and locallegislation prior to admission to the trial
Male or female who is ≥ 18 (or who is of legal age in countries where that isgreater than 18) and ≤ 75 years old at screening (Visit 1a)
Clinical signs of Clinically Significant Portal Hypertension (CSPH) as described byeither one of the points below. Each trial patient must have a gastroscopy duringthe screening period (Visit 1b) or within 6 months prior to screening (Visit 1b).
documented endoscopic proof of oesophageal varices and / or gastric varices atscreening (Visit 1b) or within 6 months prior to screening (Visit 1b)
documented endoscopic-treated oesophageal varices as preventative treatment
CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) ≥ 10 mmHg (measuredat Visit 1c), based on a local interpretation of the pressure tracing
Diagnosis of compensated cirrhosis due to Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Non-Alcoholic Steatohepatitis (NASH) with or without Type 2 DiabetesMelitus (T2DM). Diagnosis of cirrhosis must be based on histology (historical datais acceptable) or on clinical evidence of cirrhosis (e.g. platelet count < 150 x 109/L [150 x 103/microlitre (μL)], nodular liver surface on imaging or splenomegalyetc.) Diagnosis of NASH based on either i. Current or historic histologicaldiagnosis of NASH OR steatosis OR ii. Clinical diagnosis of NASH based on historicor current imaging diagnosis of fatty liver (Fibroscan, Ultrasound (US), MagneticResonance Imaging (MRI), Computed Tomography (CT)) AND at least 2 current orhistoric comorbidities of the metabolic syndrome (overweight/obesity, T2DM,hypertension, hyperlipidemia)
Willing and able to undergo HVPG measurements per protocol (based on Investigatorjudgement)
If receiving statins must be on a stable dose for at least 3 months prior toscreening (Visit 1b), with no planned dose change throughout the trial
If receiving treatment with Non-Selective Beta-Blocker (NSBBs) or carvedilol must beon a stable dose for at least 1 months prior to screening (Visit 1b), with noplanned dose change throughout the trial
Further inclusion criteria apply
Exclusion
Exclusion Criteria:
Previous clinically significant decompensation events (e.g. ascites [more thanperihepatic ascites], Variceal Haemorrhage (VH) and / or overt / apparent HepaticEncephalopathy (HE))
History of other forms of chronic liver disease (e.g. alcohol-related liver disease (ARLD), autoimmune liver disease, primary biliary sclerosis, primary sclerosingcholangitis, Wilson's disease, haemachromatosis, alpha-1 antitrypsin [A1At]deficiency)
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 inNASH)
if received curative anti-viral therapy for HCV, no sustained virologicalresponse (SVR) or SVR sustained for less than 2 years prior to screening or ifHCV Ribonucleic Acid (RNA) detectable
If receiving anti-viral therapy for HBV, less than 6 months on a stable doseprior to screening, with planned dose change during the trial or HBVdeoxyribonucleic acid (DNA) detectable
Weight change ≥ 5% within 6 months prior screening
Must take, or wishes to continue the intake of, restricted concomitant therapy orany concomitant therapy considered likely (based on Investigator judgement) tointerfere with the safe conduct of the trial
Systolic Blood Pressure (SBP) < 100 mmHg and Diastolic Blood Pressure (DBP) < 70mmHg at screening (Visit 1a)
Model of End-stage Liver Disease (MELD) score of > 15 at screening (Visit 1a),calculated by the central laboratory
Hepatic impairment defined as a Child-Turcotte-Pugh score ≥ B8 at screening (Visit 1a), calculated by the site, using central laboratory results
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 5 times upperlimit of normal (ULN) at screening (Visit 1a), measured by the central laboratory
Further exclusion criteria apply
Study Design
Connect with a study center
Hospital Britanico de Buenos Aires
Caba, 1280AEB
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Caba, C1199ABB
ArgentinaSite Not Available
AKH - Medical University of Vienna
Wien, 1090
AustriaSite Not Available
ULB Hopital Erasme
Bruxelles, 1070
BelgiumSite Not Available
Edegem - UNIV UZ Antwerpen
Edegem, 2650
BelgiumSite Not Available
CHUM Centre de recherche
Montreal, Quebec H2X 0A9
CanadaActive - Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0A9
CanadaSite Not Available
Beijing Friendship Hospital
Beijing, 100050
ChinaSite Not Available
NanFang Hosptial
Guangzhou, 510515
ChinaSite Not Available
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, 310015
ChinaSite Not Available
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032
ChinaSite Not Available
Zhongshan Hospital Fudan University
Shanghai, 200032
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, 430022
ChinaSite Not Available
Hvidovre Hospital
Hvidovre, 2650
DenmarkSite Not Available
HOP Beaujon
Clichy, 92118
FranceSite Not Available
HOP Rangueil
Toulouse, 31059
FranceSite Not Available
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
GermanySite Not Available
Universitätsklinikum Münster
Münster, 48149
GermanySite Not Available
Rambam Medical Center
Haifa, 31096
IsraelSite Not Available
Western Galilee Hospital
Nahariya, 2210001
IsraelSite Not Available
Ospedale Civile di Baggiovara
Baggiovara (MO), 41126
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Azienda Ospedaliera Policlinico di Modena
Modena, 41124
ItalySite Not Available
A.O. Univ. Policlinico "Paolo Giaccone"
Palermo, 90127
ItalySite Not Available
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375
JapanSite Not Available
National Hospital Organization Yokohama Medical Center
Kanagawa, Yokohama, 245-8575
JapanSite Not Available
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586
JapanSite Not Available
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Amsterdam UMC, location VUMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"
Cluj-Napoca, 400000
RomaniaSite Not Available
Singapore General Hospital
Singapore, 169608
SingaporeSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Vall d'Hebron-Barcelona-47683
Barcelona, 08035
SpainSite Not Available
Hospital Ramón y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Puerta de Hierro
Majadahonda, 28222
SpainSite Not Available
University Hospital Basel
Basel, 4031
SwitzerlandSite Not Available
Aintree University Hospital
Liverpool, L9 7AL
United KingdomSite Not Available
California Liver Research Institute
Pasadena, California 91105
United StatesSite Not Available
Inland Empire Clinical Trials, LLC
Rialto, California 92377
United StatesSite Not Available
Floridian Clinical Research
Miami Lakes, Florida 33016
United StatesSite Not Available
Floridian Clinical Research-Miami Lakes-68368
Miami Lakes, Florida 33016
United StatesSite Not Available
American Research Corporation
San Antonio, Texas 78215
United StatesSite Not Available
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