Clinical trials: Hepatic Encephalopathy
Liver Cirrhosis, Sleep Disturbance
Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy.
- Conditions
- Liver Cirrhosis, Sleep Disturbance, Hepatic Encephalopathy
- Trial name
- NCT07830303
- Testing
- Daridorexant
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- Wang Fengmei
Liver Cirrhosis, Hepatic Encephalopathy (HE)
Equivalence of Electronic vs Paper-based PHES in Diagnosing Hepatic Encephalopathy
The goal of this clinical trial is to learn if an electronic version of the Psychometric Hepatic Encephalopathy Score (PHES) works as well as the standard paper version to diagnose minimal hepatic encephalopathy (MHE) in adults…
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy (HE), Minimal Hepatic Encephalopathy
- Trial name
- NCT07874204
- Testing
- Paper-based PHES, Electronic PHES
- Volunteers
- 80 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Cirrhosis, Portal Hypertension
4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
PORTAL-4D is a prospective, interventional, non-randomized, parallel-group diagnostic study conducted at Pitié-Salpêtrière Hospital (Paris, France).
- Trial name
- PORTAL-4D (NCT07554183)
- Testing
- 4D-Flow Liver and heart MRI with Gadolinium injection, Samples Without DNA
- Where
- 2 sites in France
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Hepatic Encephalopathy, Minimal Hepatic Encephalopathy
A Prospective Cohort Study on the Epidemiological Investigation, Diagnosis, and Treatment of Hepatic Encephalopathy
Purpose Hepatic encephalopathy (HE) is a serious complication of liver cirrhosis that can cause memory loss, slow reaction, and even coma.
- Conditions
- Hepatic Encephalopathy, Minimal Hepatic Encephalopathy, Liver Cirrhosis
- Trial name
- NCT07612670
- Testing
- wechat mini-program
- Where
- China
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Liver Cirrhosis, Hepatic Encephalopathy
Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy
This is a prospective, multicenter, randomized crossover diagnostic accuracy study. A total of 80 patients with liver cirrhosis will be enrolled and randomly assigned to two sequence groups at a 1:1 ratio.
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy, Minimal Hepatic Encephalopathy
- Trial name
- NCT07852416
- Testing
- Paper-based Psychometric Hepatic Encephalopathy Score (PHES), Electronic Psychometric Hepatic Encephalopathy Score (PHES)
- Where
- 2 sites in China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Hepatic Encephalopathy
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased…
- Trial name
- NCT04096014
- Testing
- Ensure Enlive, Standard Of Care
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- The Cleveland Clinic
Acute on Chronic Liver Failure (ACLF), Hepatic Encephalopathy (HE)
RENEW: Study of Porcine Liver Support in Participants With Acute-on-Chronic Liver Failure
This is a Phase 1/2, first-in-human (FIH) safety, proof-of-concept, two-part study of the genetically-engineered EGEN-5784 liver in combination with the metra® extra-corporeal liver cross-circulation (ELC) system in participants…
- Trial name
- NCT07429838
- Testing
- metra® Extracorporeal Liver Cross-Circulation (ELC) system (OrganOx), EGEN-5784 (genetically engineered porcine liver)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- eGenesis, INC
Hepatic Encephalopathy, Dysbiosis
Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment
This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients…
- Trial name
- NCT06368895
- Testing
- Fecal microbiota transplantation delivery through colonoscopy, Fecal microbiota transplantation delivery through oral capsules
- Where
- Italy
- Volunteers
- 33 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hepatic Encephalopathy
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy
A total of 40 patients taking proton pump inhibitors (PPIs) who undergo transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized in 1:1 fashion to either continue or…
- Trial name
- NCT05070351
- Testing
- PPI deprescribing
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Duke University
Hepatic Encephalopathy, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Coil-Assisted Small-Diameter Covered-Stent Shunt Reduction for Refractory Hepatic Encephalopathy After TIPS
Refractory hepatic encephalopathy (RHE) after transjugular intrahepatic portosystemic shunt (TIPS) is a serious complication that can markedly impair quality of life and worsen prognosis.
- Conditions
- Hepatic Encephalopathy, Transjugular Intrahepatic Portosystemic Shunt (TIPS), Portal Hypertension, Liver Cirrhosis
- Trial name
- NCT07799948
- Testing
- Coil-assisted Small-diameter Stent Shunt reduction
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Air Force Military Medical University, China
Cirrhosis, Hepatic Encephalopathy
Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement
Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory…
- Trial name
- HEAL-LAST (NCT06052176)
- Testing
- Albumin Infusion
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
Acute Liver Failure, Fulminant Hepatic Failure
TReatment for ImmUne Mediated PathopHysiology
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure.
- Conditions
- Acute Liver Failure, Fulminant Hepatic Failure, Hepatic Encephalopathy, Acute Liver Injury
- Trial name
- TRIUMPH (NCT04862221)
- Testing
- High-dose methylprednisolone, Equine anti-thymocyte globulin, Prednisolone
- Where
- 17 sites in United States
- Volunteers
- 44 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cirrhosis, Hepatic Encephalopathy
Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis
The study aims to compare the potential benefit of allopurinol versus atorvastatin in reducing the risk of developing cirrhosis-related complications, delaying the onset of hepatocellular carcinoma, and improving survival.
- Conditions
- Cirrhosis, Hepatic Encephalopathy, Ascites, Varices
- Trial name
- NCT05511766
- Testing
- Allopurinol 300 MG, Atorvastatin 20mg
- Where
- Egypt
- Volunteers
- 150 people
- Sponsor
- Tanta University
Hepatic Encephalopathy, Covert Hepatic Encephalopathy
Affect of Melatonin on Sleep and Cognition in Cirrhosis
The goal of this clinical trial is to learn the affect of melatonin on sleep, cognitive function, and quality of life (QoL) in patients with cirrhosis and a complication called hepatic encephalopathy (HE).
- Conditions
- Hepatic Encephalopathy, Covert Hepatic Encephalopathy, Cirrhosis, Sleep Disturbances and Insomnia
- Trial name
- SNORE-HE (NCT07046429)
- Testing
- Melatonin tablet 3 mg once daily, Thiamine
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Weill Medical College of Cornell University
Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis
Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
Patients with decompensated liver cirrhosis are mostly managed in Internal Medicine outpatient clinics and wards; among these patients, overt hepatic encephalopathy represents one of the most frequent causes of emergency hospital…
- Conditions
- Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis, Liver Stiffness, Hepatic Encephalopathy
- Trial name
- HEPTAGON (NCT07727070)
- Where
- 41 sites in Italy
- Volunteers
- 400 people
- Sponsor
- Fadoi Foundation, Italy
Hypertension, Portal, Ascites
Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents
For this study, the investigators will be collecting data based on patients' random selection to two different approved standard of care treatments for ascites: Subjects will get randomized into either Group A: Large Volume…
- Trial name
- NCT04315571
- Testing
- Gore® Viatorr® Endoprosthesis with controlled expansion, Large Volume Paracentesis with albumin infusion
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of California, Los Angeles
Hepatic Encephalopathy, Fecal Microbiota Transplantation
Fecal Microbiota Transplantation for the Treatment of Refractory Hepatic Encephalopathy After TIPS Surgery
This is a single-center, prospective, open-label, parallel-group exploratory clinical study designed to evaluate the safety and preliminary efficacy of fecal microbiota transplantation combined with standard medical therapy in…
- Conditions
- Hepatic Encephalopathy, Fecal Microbiota Transplantation, TIPS, Refractory Hepatic Encephalopathy
- Trial name
- NCT07683936
- Testing
- Fecal Microbiota Transplantation, Rifaximin、Lactulose, Dietary Fiber Prebiotic
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Air Force Military Medical University, China
Gastric Varices
Pre-emptive RTO for An Early Detected Gastric Varices in CT/MR Angiogram Trial
A number of treatment modalities are currently in use for gastric variceal bleeding (GVB). Balloon-occluded, plug-assisted, and coil-assisted retrograde transvenous obliteration (RTO) procedures are described in the literature as…
- Trial name
- PRADA (NCT07168395)
- Testing
- Non-selective beta blockers, Retrograde transvenous obliteration
- Volunteers
- 68 people
- Sponsor
- University of California, Los Angeles
Liver Cirrhosis, Gastroesophageal Varices Bleeding
Comparison of Underdilated Versus Standard TIPS in Preventing Variceal Rebleeding in Patients With Cirrhosis
Transjugular intrahepatic portosystemic shunt (TIPS) is a key therapeutic intervention for complications of portal hypertension.
- Trial name
- UVR-TIPS (NCT07253389)
- Testing
- Underdilated TIPS, Standard TIPS
- Where
- China
- Volunteers
- 648 people
- Sponsor
- Air Force Military Medical University, China