Clinical trials: Hepatic Decompensation
Compensated Advanced Chronic Liver Disease
Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)
Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation.
- Trial name
- NCT05100485
- Testing
- Esophagogasrtoduodendoscopy, Hepatic venous pressure gradient
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
Hypertension, Portal, Liver Cirrhosis
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
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.
- Trial name
- NCT06082843
- Testing
- Avenciguat
- Where
- 15 sites in United States, Austria and 8 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Acute Decompensation of Liver Cirrhosis, Established Acute-on-Chronic Liver Failure
Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure
Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients with Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure
- Trial name
- CONTROL-ACLF (NCT07694297)
- Testing
- NTZ 500mg BID on top of SOC
- Volunteers
- 16 people
- Sponsor
- Genfit
Quality of Life, the Incidence of Whole Complications Resultant From Decompensated Liver
Statin Impact on Hepatic Decompensation
The study aims to evaluate the impact of statin on hepatic decompensation.
- Trial name
- NCT05563389
- Testing
- Atorvastatin 20mg
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Tanta University
Hepatic Encephalopathy
Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis
Study RNLC3131 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE)…
- Trial name
- RED-C-3131 (NCT05071716)
- Testing
- Rifaximin SSD
- Where
- 150 sites in United States, Australia and 2 more
- Volunteers
- 524 people
- Sponsor
- Bausch Health Americas, Inc.
Cirrhosis and Chronic Liver Disease
Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis
The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis.
- Trial name
- SoLiDaRity (NCT07438288)
- Testing
- Observation
- Where
- 3 sites in Singapore
- Volunteers
- 2,200 people
- Sponsor
- Singapore General Hospital
Cirrhosis
Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis
This phase III, randomized, double-blind, placebo-controlled, multi-center study seeks to test whether simvastatin, a statin usually used to lower cholesterol to prevent heart problems and strokes, can lower the risk of hepatic…
- Trial name
- SACRED (NCT03654053)
- Testing
- Simvastatin 40mg
- Where
- 11 sites in United States
- Volunteers
- 142 people
- Sponsor
- VA Office of Research and Development
Gastric Varices Bleeding, Liver Decompensation
Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding
The goal of this randomized controlled trial is to compare the rebleeding rate in cirhotic patients with gastric variceal bleeding receiving balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue…
- Trial name
- NCT06106971
- Testing
- Sodium tetradecyl sulfate, Cyanoacrylate
- Where
- Taiwan
- Volunteers
- 68 people
- Sponsor
- Kaohsiung Veterans General Hospital.
Cirrhosis
Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Heparin in Child-Pugh B Cirrhotic Patients
Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in cirrhotic patients
- Trial name
- Childbenox (NCT02271295)
- Testing
- Enoxaparine
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Liver Cirrhosis, Portal Hypertension
ABMSC Infusion Through Hepatic Artery in Portal Hypertension Surgery for the Treatment of Liver Cirrhosis
In recent years, the safety and efficacy of autologous bone marrow stem cells infusion (ABMSCi) therapy were confirmed. The investigators attempted to infuse autologous bone marrow stem cells (ABMSC) through inserting a catheter…
- Conditions
- Liver Cirrhosis, Portal Hypertension, Hepatic Decompensation, Surgery
- Trial name
- NCT01560845
- Testing
- Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgery, open abdominal portal hypertension surgery
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Wenzhou Medical University
Acute-On-Chronic Liver Failure, Ascites
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and…
- Trial name
- NCT05900050
- Testing
- VS-01 on top of SOC, SOC (Control Group)
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Genfit
Decompensated Cirrhosis
Risk Stratification for Adverse Events in End-Stage Liver Disease
Study Goal The goal of this multicenter, prospective observational cohort study is to develop and validate a multimodal predictive model that integrates portal hypertension, inflammation, and liver function indicators to predict…
- Trial name
- D-TECT (NCT07880678)
- Testing
- Routine Clinical Care with Biospecimen Collection and Free MRE Testing
- Volunteers
- 2,235 people
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
Cirrhosis, Liver Failure
Transfer Factor Efficacy in the Management of Cirrhosis-associated Immune Dysfunction
This study is aimed to assess the efficacy of Human derived Transfer factor ( T-lymphocytes homogenate that contains small molecular weight (10 kDa) molecules: various IFNs, ILs, chemokines, endorfins, heat shock proteins) in…
- Trial name
- IMUNO-HEGITO7 (NCT02837939)
- Testing
- Human derived Transfer factor, Aqua pro injectione 4ml ampules for subcutaneous injection
- Where
- Slovakia
- Sponsor
- Martin Janičko
Portal Hypertension, Hepatic Decompensation
Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
The goal of this randomised controlled trial is to evaluate the effect of carvedilol (a non-selective beta-blocker) in patients with compensated advanced chronic liver disease under clinically significant portal hypertension or…
- Conditions
- Portal Hypertension, Hepatic Decompensation, Advanced Chronic Liver Disease
- Trial name
- BB_cACLD (NCT06449339)
- Testing
- Carvedilol
- Where
- Hong Kong
- Volunteers
- 474 people
- Sponsor
- Chinese University of Hong Kong
Cirrhosis, Esophageal and Gastric Varices
Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study designed to evaluate the efficacy and safety of apixaban in combination with carvedilol versus placebo with carvedilol in preventing…
- Conditions
- Cirrhosis, Esophageal and Gastric Varices, Ascites, Hepatic Encephalopathy
- Trial name
- APIXABAN-PK (NCT07521332)
- Testing
- Apixaban, Carvedilol
- Where
- Pakistan
- Volunteers
- 220 people
- Sponsor
- Asian Institute Of Medical Sciences
End-stage Liver Disease (ESLD), Cirrhosis, Liver
RTX001 Autologous Engineered Macrophages for Liver Cirrhosis
The purpose of this study is to assess the safety and efficacy of RTX001 in patients with end-stage liver disease. This study is the first time RTX001, a macrophage cell therapy engineered to have an anti-inflammatory and…
- Conditions
- End-stage Liver Disease (ESLD), Cirrhosis, Liver, Cirrhosis, Decompensated, Liver Diseases
- Trial name
- EMERALD (NCT06823713)
- Testing
- RTX001
- Where
- 15 sites in Spain, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Resolution Therapeutics Limited
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Encephalopathy
Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis
Study RNLC3132 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin SSD-40mg IR for the delay of the first episode of overt hepatic encephalopathy (OHE)…
- Trial name
- RED-C-3132 (NCT05297448)
- Testing
- Rifaximin SSD
- Where
- 188 sites in United States, Australia and 15 more
- Volunteers
- 466 people
- Sponsor
- Bausch Health Americas, Inc.
Liver Cirrhosis
Study in Patients With Decompensated Liver Cirrhosis
OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis.
- Trial name
- OPAL (NCT06380335)
- Where
- 12 sites in Spain, United Kingdom
- Volunteers
- 24 people
- Sponsor
- Resolution Therapeutics Limited
Decompensated Cirrhosis, Cirrhotic Cardiomyopathy
Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival
Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.
- Conditions
- Decompensated Cirrhosis, Cirrhotic Cardiomyopathy, Cirrhosis, Liver, Left Ventricular Diastolic Dysfunction
- Trial name
- CIRROSTAT (NCT06431919)
- Testing
- Simvastatin 20mg, Carvedilol 3.125 mg
- Where
- India
- Volunteers
- 260 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh