Clinical trials: Liver Decompensation
Acute-On-Chronic Liver Failure
TRimetazidine for acUte on Chronic Liver Failure STudy
The study will assess the pharmacokinetics (PK), tolerability, and safety of oral trimetazidine administered to subjects with AD (ACLF Grade 0) or with ACLF Grade 1 or 2.
- Trial name
- TRUST (NCT03737448)
- Testing
- Trimetazidine
- Where
- 24 sites in Austria, Belgium and 3 more
- Volunteers
- 30 people
- Sponsor
- Martin Pharmaceuticals
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 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.
Hepatocellular Carcinoma
MONTEROSA - Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quality of Life, Effectiveness, and Safety of Tremelimumab Plus Durvalumab in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Received no Prior Systemic Treatment.
Italian multicenter observational study to evaluate time to clinical hepatic decompensation, quality of life, effectiveness, and safety of tremelimumab plus durvalumab in patients with advanced or unresectable hepatocellular…
- Trial name
- MONTEROSA (NCT07607769)
- Testing
- STRIDE
- Where
- 24 sites in Italy
- Volunteers
- 200 people
- Sponsor
- AstraZeneca
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital…
- Trial name
- DPAILO-1 (NCT06344364)
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- 3 sites in Hong Kong, Spain
- Volunteers
- 1,241 people
- Sponsor
- PharmaNest, 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
Amatoxin Poisoning, Amanita Poisoning
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history, gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become available).
- Conditions
- Amatoxin Poisoning, Amanita Poisoning, Mushroom Poisoning, Liver Failure
- Trial name
- NCT00915681
- Testing
- Silibinin
- Where
- 2 sites in United States
- Volunteers
- 148 people
- Sponsor
- Mylan Specialty, LP
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
Hepatic Encephalopathy
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.
- Trial name
- NCT04128462
- Testing
- MNK-6105, Standard of Care
- Sponsor
- Mallinckrodt
Acute Liver Failure, Acute-On-Chronic Liver Failure
F573 for Injection for the Treatment of Liver Injury/Failure
This study was a randomized, double-blind, placebo-controlled PhaseⅡ clinical trial . The primary objective of this study was to evaluate the safety of F573 for injection in patients with liver injury (drug-induced liver injury…
- Trial name
- NCT05689645
- Testing
- F573 for injection, Sterilizing water for injection
- Where
- 10 sites in China
- Volunteers
- 97 people
- Sponsor
- Beijing Continent Pharmaceutical Co, 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
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
Liver Failure
Fast-track LiveR: Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test
The purpose of this study is to investigate safety and efficacy of intravenously injected 0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on patients with partial liver resection.
- Trial name
- NCT01785082
- Testing
- 13-C-Methacetin
- Where
- 4 sites in Germany
- Volunteers
- 149 people
- Sponsor
- Humedics GmbH
Cirrhosis, Hepatic Encephalopathy
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).
- Trial name
- HALT-HE (NCT00999167)
- Testing
- HPN-100
- Where
- 28 sites in United States
- Volunteers
- 189 people
- Sponsor
- Amgen
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 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
Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout
Extended Drug Utilization Study Among Patients Exposed to Ticagrelor, Clopidogrel and Prasugrel
The purpose of the study is to describe patient characteristics and drug usage among patients that are prescribed ticagrelor for the first time and to compare them with patients who are prescribed clopidogrel and prasugrel for…
- Trial name
- NCT01276275
- Testing
- Risk of selected safety events
- Where
- Sweden
- Volunteers
- 7,200 people
- Sponsor
- AstraZeneca
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
Stem Cells, Adult Stem Cells
Safety Study of Stemchymal® in Acute Liver Failure
To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.
- Conditions
- Stem Cells, Adult Stem Cells, Acute Liver Failure, Acute-On-Chronic Liver Failure
- Trial name
- ALF (NCT03629015)
- Testing
- Stemchymal®
- Where
- Taiwan
- Sponsor
- Steminent Biotherapeutics Inc.