Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05161481

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

Hypertension, Portal Clinical Trial

Official title:
Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Investigate the Effects of Two Doses (Up-titration to a Fixed Dose Regimen) of Oral BI 685509 on Portal Hypertension After 24 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05161481
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Terminated
Phase Phase 2
Start date February 3, 2022
Completion date June 12, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03713606 - Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
Recruiting NCT02505152 - Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy N/A
Recruiting NCT02504034 - Interventional Radiology for the Treatment of Symptomatic Portal Hypertension in Patients With Cavernous Transformation of Portal Vein N/A
Completed NCT02669875 - Serelaxin To Lower Portal Pressure Phase 2
Recruiting NCT04720456 - SHAPE of Portal Hypertension in Children Phase 2
Completed NCT04645550 - Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT） Phase 4
Recruiting NCT02305914 - Follow-up Study of Complications of Acute Pancreatitis N/A
Completed NCT01095185 - Efficacy of Statin Association With Standard Treatment in Prevention of Recurrent Hemorrhage in Patient With Cirrhosis and Variceal Bleeding Phase 3
Terminated 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) Phase 2
Completed NCT00004641 - A Study to Prevent Complications of High Blood Pressure Caused by Hepatitis in Patients With Cirrhosis Phase 2
Completed NCT03138915 - Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701) N/A
Completed NCT03175731 - PPIs and Gastroesophageal Varices in Liver Cirrhosis (PPIs: Proton Pump Inhibitors) Phase 4
Active, not recruiting NCT04315571 - Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents N/A
Completed NCT03459378 - Outcome After TIPS
Recruiting NCT03470389 - Establishment and Assessment of the HVPG Using Biofluid Mechanics (HVPGBFM) N/A
Completed NCT02462967 - Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis Phase 2
Active, not recruiting NCT01097811 - Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy N/A
Terminated 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 Phase 2
Recruiting NCT03315767 - Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (SAPHES) N/A
Completed NCT03766880 - MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802) N/A