Clinical trials: Liver Decompensation
Acute on Chronic Hepatic Failure, Acute Liver Failure
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver…
- Conditions
- Acute on Chronic Hepatic Failure, Acute Liver Failure, Liver Cirrhosis, Acute Alcoholic Hepatitis
- Trial name
- NCT01937130
- Testing
- IDN-6556
- Where
- 26 sites in United States, United Kingdom
- Volunteers
- 23 people
- Sponsor
- Conatus Pharmaceuticals Inc.
End-stage Liver Disease (ESLD), Liver Transplant
A Physical Activity Program in End-state Liver Disease
The primary aim of this study is to improve both physical fitness and sarcopenia of patients with ESLD who are potentially eligible for liver transplantation through a 12-week physical training program.
- Conditions
- End-stage Liver Disease (ESLD), Liver Transplant, Sarcopenia, Poor Physical Fitness
- Trial name
- NCT02776553
- Testing
- Nutritional consultation, Physical training program, Behavioral modification therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Arkansas
Hepatitis C
Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis
1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as…
- Trial name
- NCT02455167
- Testing
- Simeprivir (SMV), Sofosbuvir (SOF), Ribavirin (RBV)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Colorado, Denver
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
Liver Failure, Carcinoma, Hepatocellular
Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A Feasibility and Safety Study
This study will assess the feasibility of lower limb-ischemia induced Remote Ischemic Conditioning (RIC) in the perioperative period before, during, and after Orthotopic Liver Transplantation (OLT).
- Trial name
- NCT02635347
- Testing
- Remote Ischemic Conditioning (RIC), Pneumatic tourniquet
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Rutgers, The State University of New Jersey
End Stage Liver Disease, Decompensated Cirrhosis of Liver
Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are: Model 1: Consultative Palliative Care (i.e.
- Trial name
- PAL-LIVER (NCT03540771)
- Testing
- Palliative Care
- Where
- 19 sites in United States
- Volunteers
- 1,494 people
- Sponsor
- Albert Einstein Healthcare Network
Hepatic Failure, Hepatic Impairment
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine, norbuprenorphine, or naloxone.
- Conditions
- Hepatic Failure, Hepatic Impairment, Chronic Hepatitis C Infection With Hepatic Coma
- Trial name
- NCT01846455
- Testing
- 2.0mg Buprenorphine/0.5mg Naloxone, Promethazine
- Where
- 3 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Hepatic Encephalopathy
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).
- Trial name
- NCT00298038
- Testing
- Rifaximin
- Volunteers
- 299 people
- Sponsor
- Bausch Health Americas, Inc.
Lactic Acidosis
Lactic Acidosis During Entecavir(ETV)Treatment
The purpose of this study is to investigate whether entecavir treatment increases the incidence of lactic acidosis compared to another nucleoside/nucleotide reverse transcriptase inhibitors (NRTI), lamivudine, and/or no NRTI…
- Trial name
- ETV (NCT01354652)
- Testing
- entecavir, lamivudine
- Volunteers
- 5 people
- Sponsor
- Asan Medical Center
Acute Liver Failure, Fulminant Hepatic Failure
Study of N-Acetylcysteine in Acute Liver Failure (ALF)
This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with acute liver failure.
- Trial name
- ONAC (NCT00896025)
- Testing
- N-acetylcysteine
- Where
- 21 sites in United States
- Volunteers
- 255 people
- Sponsor
- University of Texas Southwestern Medical Center
Hepatic Encephalopathy
Manganese in Women With Encephalopathy
Objective: Report manganese serum levels and mortality in encephalopathic patients. Patients and participants: Consecutive patients aged > 18 years, with hepatic encephalopathy and informed consent signed by their families.
- Trial name
- NCT00985010
- Where
- Mexico
- Volunteers
- 9 people
- Sponsor
- Materno-Perinatal Hospital of the State of Mexico
Acute-On-Chronic Liver Failure
TAK-242 in Patients With Acute Alcoholic Hepatitis
A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of…
- Trial name
- NCT04620148
- Testing
- TAK-242
- Where
- 3 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- Akaza Bioscience Ltd
Hepatitis C, Cirrhosis
Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection.
- Conditions
- Hepatitis C, Cirrhosis, Portal Hypertension, With or Without Liver Decompensation
- Trial name
- NCT01687257
- Testing
- SOF, RBV
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
Liver Failure
Superior Vena Cava and Its Relationship to Central Venous Pressure Measurements in Liver Transplantation
Consecutive patients undergoing liver transplant surgery will be included in the study. Before surgical incision, during the preanhepatic phase, during the anhepatic phase, during the postanhepatic phase and following closure of…
- Trial name
- NCT02818218
- Testing
- Liver Transplant
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- The Cleveland Clinic
Liver Failure, Liver Diseases, Alcoholic
BRIDGE Device for Post-operative Pain Control
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity.
- Conditions
- Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative
- Trial name
- BRIDGE (NCT03265249)
- Testing
- BRIDGE device
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Duke University
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
- 517 people
- Sponsor
- Bausch Health Americas, Inc.
End Stage Liver Disease
Procurement of Leukapheresis Products From End Stage Liver Disease (ESLD) Patients for Immunological Studies
Regulatory CD4+CD25+ T cells (Treg) derived from the thymus and/or periphery can control immune responsiveness to auto- and allo-antigens.
- Trial name
- NCT02447926
- Testing
- Leukapheresis
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Northwestern University
End Stage Cardiac Failure, Pulmonary Failure
Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues such as skin, heart, lung…
- Conditions
- End Stage Cardiac Failure, Pulmonary Failure, End Stage Liver Disease, Morbid Obesity
- Trial name
- NCT00678834
- Testing
- To surgery patients, Tocopherol capsules., Tocotrienol to healthy subjects., To surgery patients, Tocotrienol capsules.
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Chandan K Sen
Cirrhosis
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled.
- Trial name
- NCT01157845
- Testing
- BreathID (Methacetin breath test)
- Where
- 4 sites in United States, Israel
- Volunteers
- 165 people
- Sponsor
- Virginia Commonwealth University
Cirrhosis, Hepatic Encephalopathy
VE303 for Treatment of Hepatic Encephalopathy (HE)
This research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy.
- Trial name
- NCT04899115
- Testing
- VE303, oral vancomycin
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Patricia Bloom