Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT06082843

A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly

Liver Cirrhosis Clinical Trial

Official title:
Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Investigate the Effects of One Dose (Up-titration to a Fixed Dose Regimen) of Oral BI 685509 on Portal Hypertension After 8 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Decompensated Cirrhosis After Their First Decompensation Event, Who Are Stabilized CTP 5-7

Clinical Trial Summary

This study is open to adults with advanced liver cirrhosis caused by hepatitis B, hepatitis C, alcohol-related liver disease, non-alcoholic steatohepatitis or other causes. People can join the study if they have high blood pressure in the portal vein (main vessel going to the liver) and bleeding in the esophagus or fluid accumulation in the belly. The purpose of this study is to find out whether a medicine called avenciguat helps people with this condition. Participants are put into 2 groups by chance. One group takes avenciguat tablets and the other group takes placebo tablets. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants take a tablet twice a day for 8 weeks. Participants are in the study for 2 to 3 months. During this time, they visit the study site regularly. At 2 of the visits, the doctors check the pressure in the liver vein by inserting a catheter (a long thin tube) that gives information about pressure in the portal vein. The change in blood pressure is then compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06082843
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Terminated
Phase Phase 2
Start date January 3, 2024
Completion date May 30, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04533932 - Endosonographic Shear Wave Elastography for Liver Stiffness
Not yet recruiting NCT06031740 - A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids N/A
Not yet recruiting NCT06026267 - Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis N/A
Not yet recruiting NCT06076330 - Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension N/A
Enrolling by invitation NCT05055713 - A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism N/A
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting NCT05515861 - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Not yet recruiting NCT03623360 - Functional MRI to Determine Severity of Cirrhosis
Not yet recruiting NCT02710227 - Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis N/A
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Active, not recruiting NCT02551250 - Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
Recruiting NCT02239991 - Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant N/A
Enrolling by invitation NCT02256514 - Open Label Trial of Immunotherapy for Advanced Liver Cancer Phase 2
Terminated NCT02311985 - Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial N/A
Terminated NCT01937130 - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF Phase 2
Recruiting NCT01728727 - Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01728688 - Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01618890 - Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding Phase 3
Recruiting NCT01724697 - Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2