Phase
Condition
Stress
Williams Syndrome
Circulation Disorders
Treatment
Placebo matching BI 685509
Placebo matching Avenciguat (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 International Councilon Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior toadmission 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
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 or within 6 months prior to screening.
documented endoscopic proof of oesophageal varices and / or gastric varices atscreening or within 6 months prior to screening
documented endoscopic-treated oesophageal varices as preventative treatment
CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) ≥ 10 mmHg, based ona local interpretation of the pressure tracing
Diagnosis of compensated alcohol-related cirrhosis. Diagnosis must be based onhistology (historical data is acceptable) or on clinical evidence of cirrhosis (e.g.platelet count < 150 x 10^9/L [150 x 10^3/µL], nodular liver surface on imaging orsplenomegaly)
Abstinence from significant alcohol misuse / abuse for a minimum of 2 months priorto screening, and the ability to abstain from alcohol throughout the trial (bothevaluated based on Investigator judgement)
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, with no planned dose change throughout the trial Further inclusioncriteria apply.
Exclusion
Exclusion Criteria:
Previous clinically significant decompensation events (e.g. ascites [more thanperihepatic ascites], Variceal Haemorrhage (VH) and / or apparent HepaticEncephalopathy (HE))
History of other forms of chronic liver disease (e.g. non-alcoholic steatohepatitis (NASH), Hepatitis B virus (HBV), untreated Hepatitis C Virus (HCV), autoimmune liverdisease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson'sdisease, haemachromatosis, alpha-1 antitrypsin (A1At) deficiency)
Has received curative anti-viral therapy with direct-acting anti-virals within thelast 2 years for HCV, or, if such treatment was > 2 years ago and there is nosustained virological response (SVR) at screening, or, must take curative anti-viraltherapy with direct-acting anti-virals throughout the trial
Alcohol-Related Liver Disease (ARLD) without adequate treatment (e.g. lifestylemodification) or with ongoing pathological drinking behaviour (misuse / abuse basedon Investigator judgement)
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
Model of End-stage Liver Disease (MELD) score of > 15 at screening, calculated bythe central laboratory
Hepatic impairment defined as a Child-Turcotte-Pugh score ≥ B8 at screening,calculated by the site, using central laboratory results Further exclusion criteriaapply.
Study Design
Connect with a study center
Hospital Britanico de Buenos Aires
Caba, C1280AEB
ArgentinaActive - Recruiting
Hospital Italiano de Buenos Aires
Caba, C1199ABB
ArgentinaSite Not Available
Medical University of Innsbruck
Innsbruck, 6020
AustriaSite 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
UZ Leuven
Leuven, 3000
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
Beijing Youan Hospital, Capital Medical University
Beijing, 100071
ChinaSite Not Available
NanFang Hosptial
Guangzhou, 510515
ChinaSite Not Available
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, 310000
ChinaSite Not Available
Zhongshan Hospital Fudan University
Shanghai, 200032
ChinaSite Not Available
Wuhan Union Hospital
Wuhan, 430022
ChinaSite Not Available
University Hospital Dubrava
Zagreb, 10000
CroatiaSite Not Available
Aarhus University Hospital
Aarhus N, 8200
DenmarkSite Not Available
Hvidovre Hospital
Hvidovre, 2650
DenmarkSite Not Available
HOP d'Angers
Angers, 49933
FranceSite 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
St. Josefs-Hospital, Wiesbaden
Wiesbaden, 65189
GermanySite Not Available
Rambam Medical Center
Haifa, 31096
IsraelSite Not Available
Western Galilee Hospital
Nahariya, 2210001
IsraelSite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalySite Not Available
Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milano, 20122
ItalyActive - Recruiting
Azienda Ospedaliera Policlinico di Modena
Modena, 41124
ItalySite Not Available
A.O. Univ. Policlinico "Paolo Giaccone"
Palermo, 90127
ItalySite Not Available
Poli Univ A. Gemelli
Roma, 00195
ItalySite Not Available
Shin-yurigaoka General Hospital
Kanagawa, Kawasaki, 215-0026
JapanSite 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
Yokohama City University Hospital
Kanagawa, Yokohama, 236-0004
JapanSite Not Available
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586
JapanSite Not Available
Soon Chun Hyang University Hospital Bucheon
Bucheon, 14584
Korea, Republic ofSite Not Available
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, 14584
Korea, Republic ofSite Not Available
Yonsei University Wonju Severance Christian Hospital
Wonju, 26426
Korea, Republic ofSite Not Available
Yonsei University Wonju Severance Christian Hospital
Wonju-si, Gangwon State, 26426
Korea, Republic ofSite Not Available
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZA
NetherlandsSite Not Available
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
ULS de Santa Maria, E.P.E
Lisboa, 1649-035
PortugalSite 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
Ospedale Regionale di Lugano
Viganello, 6962
SwitzerlandSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Queen Elizabeth Hospital
Birmingham, B15 2TH
United KingdomSite Not Available
Queen Elizabeth Hospital -Birmingham-19820
Birmingham, B15 2TH
United KingdomSite Not Available
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2TH
United KingdomSite Not Available
Aintree University Hospital
Liverpool, L9 7AL
United KingdomSite Not Available
Royal Free Hospital
London, NW3 2QG
United KingdomActive - Recruiting
St Mary's Hospital
London, W2 1NY
United KingdomSite Not Available
Queen's Medical Centre
Nottingham, NG7 2UH
United KingdomSite Not Available
Southampton General Hospital
Southampton, SO16 6YD
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
Northwell Health Center for Liver Disease
Manhasset, New York 11030
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
American Research Corporation at the Texas Liver Institute
San Antonio, Texas 78215
United StatesSite Not Available
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