Clinical trials: Acute Liver Failure
Liver Failure, Acute on Chronic
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure
- Trial name
- NCT03863002
- Testing
- Mesenchymal Stem Cell
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Tianjin Weikai Bioeng., Ltd.
Acute Liver Failure
Emergency Use of OCR-002 in Acute Liver Failure (ALF)
This study provides emergency use of the unapproved study medication in ALF patients with acute liver failure who are not responding to standard of care.
- Trial name
- NCT01634230
- Testing
- OCR-002
- Where
- United States
- Sponsor
- Ocera Therapeutics, Inc.
Liver Failure, Acute
Efficacy & Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis & Early Stage Acute Liver Failure
Acute liver failure is a rare but dramatic disease, often affecting young people, marked by the sudden loss of liver function in a person without preexisting liver disease.
- Trial name
- NCT01318525
- Testing
- ALF-5755, Saline solution (0.9% NaCl)
- Where
- 12 sites in France
- Volunteers
- 60 people
- Sponsor
- Alfact Innovation
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
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
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-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 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 Hepatic Failure, Liver Failure
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
This is a multicenter, randomized, controlled, open-label phase 1/2 clinical study conducted in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial liver support system (HepaCure) plus DPMAS…
- Conditions
- Acute on Chronic Hepatic Failure, Liver Failure, Hepatitis
- Trial name
- NCT05989958
- Testing
- HepaCure, DPMAS and LPE
- Where
- China
- Volunteers
- 92 people
- Sponsor
- Hexaell Biotech Co., Ltd.
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
Fulminant Hepatic Failure
Phase 2 Evaluation of the ELAD System in the Management of Acute Liver Failure
The purpose of this study is to determine if treatment with the ELAD Bioartificial Liver Assist Device is beneficial to patients in Acute Liver Failure either as a bridge to liver transplant or bridge to native liver recovery.
- Trial name
- NCT00030225
- Testing
- ELAD, Standard of care (Control)
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Vital Therapies, Inc.
Hepatorenal Syndrome, Acute Kidney Injury
Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome
This study aims to evaluate the safety, tolerability and efficacy of R2R01 combined with terlipressin as compared to terlipressin alone in the treatment of patients with HRS-AKI
- Trial name
- NCT05875948
- Testing
- R2R01, Terlipressin
- Where
- 7 sites in United States
- Volunteers
- 95 people
- Sponsor
- River 2 Renal Corp.
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.
Hepatitis, Pharmacology
A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and SafeTynadol® in Healthy Volunteers
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.
- Trial name
- NCT05563961
- Testing
- Panadol®, SafeTynadol®
- Where
- Taiwan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sinew Pharma Inc.
Acute Hepatitis, Chronic Hepatitis
Safety & Efficacy of the Extracorporeal Liver Assist Device (ELAD) System in Patients With Hepatic Insufficiency
Evaluate on how well the ELAD system works in treating people with liver failure.
- Trial name
- ELAD (NCT00771446)
- Testing
- ELAD plus standard of care treatment, Standard of care treatment
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Vital Therapies, Inc.
Fulminant Hepatic Failure
Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)
This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical…
- Trial name
- ELAD (NCT00832728)
- Testing
- Standard of Care, ELAD®
- Where
- 12 sites in United States
- Sponsor
- Vital Therapies, 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 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.
Multiple Myeloma
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form…
- Trial name
- NCT02921828
- Where
- 2 sites in United States, Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
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