Clinical trials: Acute Liver Failure
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
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.
Liver Failure, Acute on Chronic
Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study
Acute on chronic liver failure (ACLF) is a distinct entity encompassing the acute deterioration of liver function, culminating in multiple organs failure and high short-term mortality.
- Trial name
- Ch-CANONIC (NCT02457637)
- Testing
- Standary therapy
- Where
- 16 sites in China
- Volunteers
- 2,600 people
- Sponsor
- Hai Li
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
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 Kidney Injury, Cirrhosis
NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients
The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury.
- Conditions
- Acute Kidney Injury, Cirrhosis, Portal Hypertension, Hepatorenal Syndrome
- Trial name
- NEPH-ROSIS (NCT06000748)
- Testing
- MAP-Target Algorithm
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of California, San Francisco
Acute Episode of Overt Hepatic Encephalopathy, Hepatic Encephalopathy
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
- Trial name
- STOP-HE (NCT01966419)
- Testing
- ornithine phenylacetate
- Where
- 131 sites in United States, Australia and 15 more
- Volunteers
- 231 people
- Sponsor
- Ocera Therapeutics, Inc.
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, 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
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.
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
Acute Liver Failure, Hepatic Encephalopathy
N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF.
- Trial name
- NCT00248625
- Testing
- N-acetylcysteine
- Where
- 20 sites in United States, Canada and 1 more
- Volunteers
- 184 people
- Sponsor
- University of Pittsburgh
Acute Liver Failure, Acute Liver Injury
Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: safety and tolerability; metabolism of the compound to glutamine and…
- Trial name
- STOP-ALF (NCT01548690)
- Testing
- Ornithine Phenylacetate
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- William Lee
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.
Kidney Failure
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04258423
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
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.
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.