Clinical trials: End Stage Liver Disease
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
End Stage Liver DIsease, Liver Failure
VitaSmart HOPE System: Bridge to HOPE Registry
This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions.
- Trial name
- NCT07578441
- Testing
- hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Bridge to Life Ltd.
Hepatitis C, Chronic
HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
- Trial name
- NCT02806505
- Testing
- Peginterferon alfa-2a
- Where
- 22 sites in Austria, Brazil and 6 more
- Volunteers
- 81 people
- Sponsor
- Hoffmann-La Roche
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.
Hepatitis C Virus Infection
Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease
The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.
- Trial name
- ESRD (NCT03036839)
- Testing
- LDV/SOF
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 95 people
- Sponsor
- Gilead Sciences
Hepatic Encephalopathy
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.
- Trial name
- EMMPOWER (NCT04816916)
- Testing
- AXA1665
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 12 people
- Sponsor
- Axcella Health, Inc
Hepatic Encephalopathy, Liver Failure
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
The primary objective of the study was to compare the efficacy, safety and tolerability of Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System (MARS®) device in improving severe HE by 2…
- Conditions
- Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic, Liver Cirrhosis
- Trial name
- NCT00287235
- Testing
- MARS, Standard Medical Therapy
- Where
- 8 sites in United States, Belgium and 1 more
- Volunteers
- 70 people
- Sponsor
- Vantive Health LLC
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.
End Stage Liver DIsease
Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease
A phase I trial to study the safety of mobilization of stem cells with G-CSF and Mozobil in patients with chronic liver disease.
- Trial name
- NCT01711073
- Testing
- Mobilization with G-CSF and Mozobil
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Proteonomix, Inc.
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 (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
Acute on Chronic Liver Failure, Alcoholic Hepatitis
CytoSorb® in Patients With Acute on Chronic Liver Failure
The objective of this study is to assess the safety and performance of the CytoSorb® therapy in patients with Acute on Chronic Liver Failure (ACLF) grade ≥ 2 due to a severe alcohol induced hepatitis (Maddrey DF > 32) and a…
- Trial name
- HepOnFire (NCT05131230)
- Testing
- CytoSorb® treatment
- Where
- 2 sites in Germany
- Sponsor
- CytoSorbents Europe GmbH
End Stage Renal Disease, Hepatitis C Infection
Safety Study of the Aethlon Hemopurifier
Primary Objectives: To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood purification. Secondary Objectives: To quantify the number of viral copies captured by the Aethlon Hemopurifier® during…
- Trial name
- AEMD-IDE-20 (NCT02215902)
- Testing
- Affinity plasmapheresis
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Aethlon Medical Inc.
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 B
A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease
The purpose of this study is to find out if a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients.
- Trial name
- NCT00498212
- Testing
- 1018 ISS-HBsAg-Single, 1018 ISS-HBsAg-Double
- Where
- 3 sites in Canada
- Volunteers
- 41 people
- Sponsor
- Dynavax Technologies Corporation
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 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