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)

PHASE2TerminatedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 28, 2022

Primary Completion Date

April 23, 2024

Study Completion Date

June 7, 2024

Conditions
Liver DiseasesHypertension, Portal
Interventions
DRUG

Avenciguat

one film-coated tablet orally twice a day, at least 10 hours apart. The starting dose (1 mg) was up-titrated up to 3 mg

DRUG

Empagliflozin

one 10 mg film-coated tablet of orally once a day

Trial Locations (31)

1090

AKH - Medical University of Vienna, Vienna

2650

Edegem - UNIV UZ Antwerpen, Edegem

Hvidovre Hospital, Hvidovre

28034

Hospital Ramón y Cajal, Madrid

30625

Medizinische Hochschule Hannover, Hanover

31059

HOP Rangueil, Toulouse

31096

Rambam Medical Center, Haifa

33016

Floridian Clinical Research-Miami Lakes-68368, Miami Lakes

41124

Azienda Ospedaliera Policlinico di Modena, Modena

41126

Ospedale Civile di Baggiovara, Baggiovara (MO)

48149

Universitätsklinikum Münster, Münster

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

78215

American Research Corporation, San Antonio

90127

"Policlinico Paolo Giaccone", Palermo

91105

California Liver Research Institute, Pasadena

92118

HOP Beaujon, Clichy

92377

Inland Empire Clinical Trials, LLC, Rialto

100050

Beijing Friendship Hospital, Beijing

169608

Singapore General Hospital, Singapore

200032

Zhongshan Hospital Affiliated to Fudan University, Shanghai

310015

The Affiliated Hospital of Hangzhou Normal University, Hangzhou

400000

"Regional Institute of Gastroenterology Hepatology Prof. Dr. O. Fodor", Cluj-Napoca

510515

NanFang Hosptial, Guangzhou

2210001

Western Galilee Hospital, Nahariya

1280AEB

Hospital Britanico de Buenos Aires, CABA

C1199ABB

Hospital Italiano de Buenos Aires, CABA

H2X 0A9

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

245-8575

National Hospital Organization Yokohama Medical Center, Kanagawa, Yokohama

545-8586

Osaka Metropolitan University Hospital, Osaka, Osaka

1105 AZ

Amsterdam UMC, location VUMC, Amsterdam

08035

Hospital Vall d'Hebron, Barcelona

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT05282121 - 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) | Biotech Hunter | Biotech Hunter