Clinical trials: Liver Decompensation
Acute Liver Failure, Fulminant Hepatic Failure
Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)
This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in subjects with acute liver failure (ALF) compared to matched historical controls.
- Conditions
- Acute Liver Failure, Fulminant Hepatic Failure, Primary Graft Non-Function, Surgically-Induced Liver Failure
- Trial name
- NCT01875874
- Testing
- ELAD
- Where
- 18 sites in United States
- Volunteers
- 8 people
- Sponsor
- Vital Therapies, Inc.
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
Seriously Ill Patients, Cancer
Goals of Care Conversations Study
The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values.
- Conditions
- Seriously Ill Patients, Cancer, Heart Failure, Interstitial Lung Disease
- Trial name
- LSTDI (NCT05001009)
- Testing
- Clinician Implementation Strategy Stage 1: low intensity clinician training, Clinician Implementation Strategy Stage 2: high intensity clinician training, Low patient engagement
- Where
- 3 sites in United States
- Volunteers
- 2,859 people
- Sponsor
- VA Office of Research and Development
Cirrhosis, Hepatic Encephalopathy
FMT in Cirrhosis and Hepatic Encephalopathy
Patients with end stage of liver disease or cirrhosis can develop confusion due to high ammonia and inflammation. This confusion is brought upon by changes in the bacteria in the bowels and may not respond to current standard of…
- Trial name
- NCT03796598
- Testing
- Fecal Microbial transplant Capsules, Fecal Microbial Transplant Enema
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- VA Office of Research and Development
Hepatic Encephalopathy
Rifaximin in Minimal Hepatic Encephalopathy
The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic…
- Trial name
- NCT00533910
- Testing
- Rifaximin
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
Cirrhosis, Ascites
The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
This study is being completed for patients with cirrhosis, including patients with a prior history of hepatic encephalopathy (HE) to evaluate the feasibility and benefits of medically-tailored meals as an intervention.
- Conditions
- Cirrhosis, Ascites, Liver Diseases, Frailty
- Trial name
- NCT04675775
- Testing
- Medically-tailored meals (MTM), Protein supplements, Nutrition education handout
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Michigan
Severe Acute Alcoholic Hepatitis
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score >0.45).
- Trial name
- NCT01829347
- Testing
- ELAD, Standard of Care treatment
- Where
- 39 sites in United States, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- Vital Therapies, Inc.
Liver Cirrhosis
Human Fetal Liver Cell Transplantation in Chronic Liver Failure
The herein study consists in the transplantation of liver progenitor cells isolated from human fetal liver tissue with the aim of improving conventional liver therapy and broadening therapeutical options other than liver…
- Trial name
- hFLCTx (NCT01013194)
- Testing
- Human Fetal Liver Cell Transplantation
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
End Stage Liver Disease
A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
The goal of this pilot randomized trial is to assess the feasibility and preliminary efficacy of an advanced care planning (ACP) video decision support tool for improving patients' knowledge regarding their goals of care options…
- Trial name
- NCT03557086
- Testing
- Advance Care Planning Video Decision Support Tool, Verbal Narrative
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Massachusetts General Hospital
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
The main reason for this study is to see how the study drug interacts with the body. It will compare different doses of the study drug with a drug already in use.
- Trial name
- NCT03712280
- Testing
- MNK6106, Rifaximin
- Where
- 5 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Mallinckrodt
End Stage Liver Disease, Hepatitis C
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant
This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
- Trial name
- NCT03208127
- Testing
- Treatment with Direct Acting Antiviral tablet
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Massachusetts General Hospital
Hepatic Encephalopathy
Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy
Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The purpose of our study is to assess sleep quality, quantity, sleep schemes and physical activity in patients suffering from HE, before and…
- Trial name
- NCT02163837
- Testing
- rifaximine
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
Hepatitis C, Hepatitis C, Chronic
Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted liver.
- Conditions
- Hepatitis C, Hepatitis C, Chronic, Nonimmune Nonviral Causes of Liver Failure
- Trial name
- A-WISH (NCT00135694)
- Testing
- calcineurin inhibitor-based immunosuppression, liver transplant, corticosteroids
- Where
- 8 sites in United States
- Volunteers
- 275 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
End Stage Liver Disease, Hepatitis C
Study of Liver Transplant For End-Stage Liver Disease Caused By Chronic Hepatitis C Infection
The purpose of this study is to compare three treatment regimens in patients who have received a liver transplant for end-stage liver disease caused by Chronic Hepatitis C infection.
- Trial name
- NCT00163657
- Testing
- Daclizumub, Tacrolimus, Cyclosporine
- Where
- United States
- Volunteers
- 312 people
- Sponsor
- Baylor Research Institute
Acute Liver Failure
13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF
The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the…
- Trial name
- ALFSG-MBT (NCT02786836)
- Testing
- 13C-Methacetin
- Where
- 11 sites in United States
- Volunteers
- 76 people
- Sponsor
- University of Texas Southwestern Medical Center
Acute-On-Chronic Liver Failure
Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects.
- Trial name
- APACHE (NCT03702920)
- Testing
- SMT + PE-A 5%, Standard Medical Treatment
- Where
- 30 sites in United States, Austria and 7 more
- Volunteers
- 274 people
- Sponsor
- Instituto Grifols, S.A.
Acute Alcoholic Hepatitis
Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day…
- Trial name
- NCT01471028
- Testing
- ELAD treatment, Standard of care (Control)
- Where
- 45 sites in United States, Australia and 2 more
- Volunteers
- 203 people
- Sponsor
- Vital Therapies, Inc.
Acute Alcoholic Hepatitis
Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD
The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.
- Trial name
- NCT02612428
- Testing
- ELAD System, Standard of Care (Control)
- Where
- 44 sites in United States, Austria and 4 more
- Volunteers
- 151 people
- Sponsor
- Vital Therapies, Inc.
Cirrhosis
A Trial to Improve Quality of Life in People With Cirrhosis
This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic…
- Trial name
- NCT05061992
- Testing
- Lactulose
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Michigan