Clinical trials: Acute-on-Chronic Liver Failure (ACLF)
Acute on Chronic Liver Failure
Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients
The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure…
- Trial name
- DIALIVE _ACLF (NCT03065699)
- Testing
- DIALIVE Liver Dialysis Device
- Where
- 12 sites in Austria, Belgium and 6 more
- Volunteers
- 30 people
- Sponsor
- Yaqrit Ltd
Acute Liver Failure, Acute Liver Injury, Drug Induced
miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on chronic liver failure.
- Conditions
- Acute Liver Failure, Acute Liver Injury, Drug Induced, Acute on Chronic Liver Failure (ACLF), Acute Alcoholic Hepatitis
- Trial name
- NCT06285253
- Testing
- miroliverELAP treatment
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Miromatrix Medical Inc.
Acute-On-Chronic Liver Failure
Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients
The goal of this clinical trial is to learn if CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection (hereinafter referred to as CG-BM1) can treat acute-on-chronic liver failure (ACLF) patients.
- Trial name
- NCT06740149
- Testing
- Bone marrow mesenchymal stem cells (low dose), Solvent of CG-BM1, Bone marrow mesenchymal stem cells (medium dose)
- Where
- China
- Volunteers
- 100 people
- Sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.
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
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
This study is intended to demonstrate the efficacy and safety of the DIALIVE Liver Dialysis Device when incorporated into the standard management plan for participants with A-TANGO ACLF grade 2-4.
- Trial name
- NCT07347275
- Testing
- Standard of Care (Investigator Choice), DIALIVE 2.0 liver dialysis Device plus available Standard of Care
- Where
- United Kingdom
- Volunteers
- 72 people
- Sponsor
- Yaqrit Ltd
Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF)
A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy
A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard…
- Conditions
- Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF), Decompensated Cirrhosis
- Trial name
- NCT06987968
- Testing
- VS-01 on top of SOC (Active Treatment Group), SOC
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 3 people
- Sponsor
- Genfit
Acute-on-Chronic Liver Failure
Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers
A Phase 1, Open-Label Study to Assess Pharmacokinetics, Safety and Tolerability of G1090N in Healthy Subjects
- Trial name
- NCT07110441
- Testing
- Single Dose G1090N, Multiple dosing of G1090N
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Genfit
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 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.
Acute-On-Chronic Liver Failure
Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.
- Trial name
- HEP101 (NCT02946554)
- Testing
- HepaStem
- Where
- 10 sites in Belgium, France
- Volunteers
- 24 people
- Sponsor
- Cellaion SA
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
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 Liver Failure, Alcoholic Hepatitis
A-TANGO Phase 2 Study
The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment…
- Conditions
- Acute-On-Chronic Liver Failure, Alcoholic Hepatitis, Liver Cirrhosis, Alcoholic
- Trial name
- A-TANGO (NCT06890039)
- Testing
- TAK-242, G-CSF (Filgrastim)
- Where
- United Kingdom
- Volunteers
- 78 people
- Sponsor
- Yaqrit Ltd
Acute on Chronic Liver Failure, Multiple Organ Failure
Feasibility Pilot Study to Evaluate the Safety and Performance of the MEX-CD1 Medical Device in ACLF
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from ACLF. The main questions it aims to answer are: Is the device safe when used according to the instructions for use?…
- Trial name
- MexACLF (NCT06340269)
- Testing
- MEX-CD1 Dialysis
- Where
- 2 sites in France
- Volunteers
- 11 people
- Sponsor
- Mexbrain
Acute on Chronic Liver Failure
Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care…
- Trial name
- DHELIVER (NCT04229901)
- Testing
- HepaStem
- Where
- 47 sites in Austria, Belgium and 12 more
- Volunteers
- 133 people
- Sponsor
- Cellaion SA
Acute-On-Chronic Liver Failure
Allogeneic ABCB5-positive Stem Cells for Treatment of Acute-on-Chronic Liver Failure
This is an interventional, single arm, multicenter, phase I/IIa clinical trial. The study objective is to investigate the efficacy and safety of three i.v.
- Trial name
- NCT03860155
- Testing
- allo-APZ2-ACLF
- Where
- 5 sites in Germany
- Volunteers
- 5 people
- Sponsor
- RHEACELL GmbH & Co. KG