A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Live

Last updated: December 22, 2024
Sponsor: Boehringer Ingelheim
Overall Status: Terminated

Phase

2

Condition

Stress

Williams Syndrome

Circulation Disorders

Treatment

Placebo matching BI 685509

Placebo matching Avenciguat (BI 685509)

Avenciguat (BI 685509)

Clinical Study ID

NCT05161481
1366-0021
2021-001285-38
  • Ages 18-75
  • All Genders

Study Summary

This study is open to adults with liver cirrhosis and high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat helps people with this condition.

Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of Avenciguat as tablets twice a day. Participants in the placebo group take placebo as tablets twice a day. Placebo tablets look like Avenciguat tablets but do not contain any medicine.

Participants are in the study for about 8 months. During this time, they visit the study site about 14 times. At 3 of the visits, the doctors check the pressure in a liver vein. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The change in blood pressure is then compared between the groups to see whether the treatment works.

The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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

  2. 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

  3. 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

  1. CSPH defined as baseline Hepatic Venous Pressure Gradient (HVPG) ≥ 10 mmHg, based ona local interpretation of the pressure tracing

  2. 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)

  3. 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)

  4. Willing and able to undergo HVPG measurements per protocol (based on Investigatorjudgement)

  5. 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:

  1. Previous clinically significant decompensation events (e.g. ascites [more thanperihepatic ascites], Variceal Haemorrhage (VH) and / or apparent HepaticEncephalopathy (HE))

  2. 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)

  3. 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

  4. Alcohol-Related Liver Disease (ARLD) without adequate treatment (e.g. lifestylemodification) or with ongoing pathological drinking behaviour (misuse / abuse basedon Investigator judgement)

  5. 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

  6. Systolic Blood Pressure (SBP) < 100 mmHg and Diastolic Blood Pressure (DBP) < 70mmHg at screening

  7. Model of End-stage Liver Disease (MELD) score of > 15 at screening, calculated bythe central laboratory

  8. 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

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: Placebo matching BI 685509
Phase: 2
Study Start date:
April 27, 2022
Estimated Completion Date:
June 12, 2024

Connect with a study center

  • Hospital Britanico de Buenos Aires

    Caba, C1280AEB
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    Caba, C1199ABB
    Argentina

    Site Not Available

  • Medical University of Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • AKH - Medical University of Vienna

    Wien, 1090
    Austria

    Site Not Available

  • ULB Hopital Erasme

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • CHUM Centre de recherche

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Beijing Friendship Hospital

    Beijing, 100050
    China

    Site Not Available

  • Beijing Youan Hospital, Capital Medical University

    Beijing, 100071
    China

    Site Not Available

  • NanFang Hosptial

    Guangzhou, 510515
    China

    Site Not Available

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, 310000
    China

    Site Not Available

  • Zhongshan Hospital Fudan University

    Shanghai, 200032
    China

    Site Not Available

  • Wuhan Union Hospital

    Wuhan, 430022
    China

    Site Not Available

  • University Hospital Dubrava

    Zagreb, 10000
    Croatia

    Site Not Available

  • Aarhus University Hospital

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Hvidovre Hospital

    Hvidovre, 2650
    Denmark

    Site Not Available

  • HOP d'Angers

    Angers, 49933
    France

    Site Not Available

  • HOP Beaujon

    Clichy, 92118
    France

    Site Not Available

  • HOP Rangueil

    Toulouse, 31059
    France

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • St. Josefs-Hospital, Wiesbaden

    Wiesbaden, 65189
    Germany

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Western Galilee Hospital

    Nahariya, 2210001
    Israel

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Milano Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Policlinico di Modena

    Modena, 41124
    Italy

    Site Not Available

  • A.O. Univ. Policlinico "Paolo Giaccone"

    Palermo, 90127
    Italy

    Site Not Available

  • Poli Univ A. Gemelli

    Roma, 00195
    Italy

    Site Not Available

  • Shin-yurigaoka General Hospital

    Kanagawa, Kawasaki, 215-0026
    Japan

    Site Not Available

  • Kitasato University Hospital

    Kanagawa, Sagamihara, 252-0375
    Japan

    Site Not Available

  • National Hospital Organization Yokohama Medical Center

    Kanagawa, Yokohama, 245-8575
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Kanagawa, Yokohama, 236-0004
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586
    Japan

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon, 14584
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggi-do, 14584
    Korea, Republic of

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Wonju, 26426
    Korea, Republic of

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Wonju-si, Gangwon State, 26426
    Korea, Republic of

    Site Not Available

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

  • ULS de Santa Maria, E.P.E

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"

    Cluj-Napoca, 400000
    Romania

    Site Not Available

  • Singapore General Hospital

    Singapore, 169608
    Singapore

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Vall d'Hebron-Barcelona-47683

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Puerta de Hierro

    Majadahonda, 28222
    Spain

    Site Not Available

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • Ospedale Regionale di Lugano

    Viganello, 6962
    Switzerland

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital -Birmingham-19820

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Aintree University Hospital

    Liverpool, L9 7AL
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

  • St Mary's Hospital

    London, W2 1NY
    United Kingdom

    Site Not Available

  • Queen's Medical Centre

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • California Liver Research Institute

    Pasadena, California 91105
    United States

    Site Not Available

  • Inland Empire Clinical Trials, LLC

    Rialto, California 92377
    United States

    Site Not Available

  • Floridian Clinical Research

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Floridian Clinical Research-Miami Lakes-68368

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Northwell Health Center for Liver Disease

    Manhasset, New York 11030
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

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