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Acute-On-Chronic Liver Failure clinical trials

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NCT ID: NCT06066814 Not yet recruiting - Clinical trials for Acute on Chronic Liver Failure

To Study the Role of Plasma Von Willebrand Factor Antigen (vWF) to A Disintegrin-like and Metalloproteinase With Thrombospondin Type-1 Motifs 13 (ADAMTS-13) Activity Ratio as a Predictor of Development of Extrahepatic Organ Failure in Acute on Chronic Liver Failure (ACLF) Patients.

Start date: October 7, 2023
Phase:
Study type: Observational

Acute on chronic liver failure (ACLF) is a syndrome characterized by acute decompensation of chronic liver disease associated with organ failures and high short- term mortality. Development of systemic inflammation and subsequent organ failures determines is associate with poor outcome and short-term mortality. Previous studies have shown that endothelial injury leading to increase in levels of and exhaustion of its cleaving protein a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS 13) which promotes the platelet microthrombi formation and subsequent organ ischemia. We propose that the vWF : ADAMTS 13 ratio can be predict the organ failure development and subsequent mortality in ACLF patients, which is considered to be a inflammatory state.

NCT ID: NCT05909319 Not yet recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Identification and Verification of Neutrophil Extracellular Trap Net Related Markers in Acute-on-chronic Liver Failure

Start date: June 25, 2023
Phase:
Study type: Observational

Acute-on-chronic liver failure (ACLF) refers to the acute deterioration of liver function in patients with chronic liver disease. Neutrophils are a major component of the innate immune system, and previous studies have revealed enhanced production of neutrophil extracellular traps (NETs) in ACLF. However, there is still a lack of systematic research on the correlation between NETs and the prognosis of ACLF. We screened NETs related biomarkers through bioinformatics analysis, which play an important role in the diagnosis of ACLF. This study will explore whether these NETs related biomarkers also play an important role in the prognosis of ACLF and further investigate their role in the pathogenesis of ACLF.

NCT ID: NCT05772585 Not yet recruiting - Clinical trials for Hepatic Encephalopathy

Characterization of Metabolomic Fingerprints in Patients With Acute Liver Failure and Acute-on-chronic Liver Failure With Hepatic Encephalopathy

EH-CASIMIR
Start date: March 2023
Phase:
Study type: Observational

Hepatic encephalopathy is a frequent complication of both acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) and could be responsible among other neurological complications of residual impairment after liver transplantation. Specific metabolomic studies have shed light into pathophysiology. Nevertheless, whether HE metabolomic fingerprints differ between HE in ALF and HE in ACLF and their evolution after liver transplantation (LT) is unknown. The aim of our study is to analyse the metabolomic fingerprint in plasma of 2 different groups of patients before and after LT: - hospitalized patients with ALF and HE - hospitalized patients with ACLF and HE We will analyse metabolomic results to explore if there is any difference in metabolomic fingerprints between these 2 groups and if LT modify the metabolomic fingerprint in plasma in these 2 groups and in the same way. We will collect blood samples in these 2 groups on the day of HE occurring and then on day 1, day 7 and day 30 (+/- 2 days) after LT. We aim to enroll 10 patients in ALF group and 20 patients in ACLF group. Inclusion criteria are defined as age > 18 years, patient presenting with ALF (Synthetic liver failure (INR > 1.5) with hepatic encephalopathy (grade 1-4 of West-Haven classification), without pre-existing hepatopathy, HE beginning within <26 weeks) or ACLF (≥ grade 1 from CANONIC criteria), and clinical HE (grade 1-4 of West-Haven classification) on the day of enrolment. Exclusion criteria are defined as age < 18 years, absence of HE, LT without pre-existing HE, patients who already undergone a LT, legally protected person. An EDTA blood sample will be collected, centrifuged and frozen on the day of enrolment, then on day 1, day 7 and day 30 (+/- 2 days) after LT. Metabolomic analyses will be performed by different techniques but especially with high resolution liquid phase mass spectrometry in collaboration with CEA. Statistical analyses will be both univariate (Mann-Whitney or Wilcoxon tests) and multivariate (with a classical and adapted method for metabolomic studies: Partial Least-Squares Discriminant Analysis (PLS-DA)). We expect to identify different metabolomic fingerprints between HE in both ALF and ACLF patients as well as different kinetics for symptoms resolution after LT. The long-term objective is to target the specific metabolic pathways for each group in order to allow development of new targeted drugs against HE in these 2 different conditions.

NCT ID: NCT05727722 Not yet recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Micro-encapsulated Hepatocyte Intraperitoneal Transplantation in Liver Failure Adults

Start date: March 1, 2023
Phase: Phase 1
Study type: Interventional

This is a prospective single-center dose escalation study of the administration of the microencapsulated hepatocyte therapy in adult liver failure. The purpose of the study is to determine the maximum tolerated dose of microencapsulated hepatocytes in liver failure patients and its effectiveness in treating the disease.

NCT ID: NCT05719051 Not yet recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Albumin Infusion in Inpatients With Decompensated Cirrhosis

Start date: February 1, 2023
Phase:
Study type: Observational

Albumin infusion in patients with hospitalized decompensated, even in short-term period use, could improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. A comprehensive evaluation of the inflammation response by robust measurement is needed to prove insights into the therapeutic implications of albumin infusion. The purpose of this study is to compare the effects of different amount of human albumin infusion per week in patients with hospitalized decompensated cirrhosis on 28-day transplant-free survival and to further compare the alleviation of inflammation, reduction of incidence of nosocomial infection, spontaneous bacterial peritonitis (SBP), acute kidney injury (AKI), acute-on-chronic liver failure (ACLF), and 90-day transplant-free survival. This will be a multicenter, national, retrospective study. There will be no randomization in this retrospective study. All patients who meet the inclusion criteria and not the exclusion criteria will be enrolled. All identified patients who meet criteria will be given an ID number comprised of a site number and patient number.

NCT ID: NCT05089981 Not yet recruiting - Clinical trials for Acute on Chronic Liver Failure(ACLF)

Intravenous NAC Use in ACLF Patients

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Primary Objective To evaluate the efficacy and safety of 72 hour NAC treatment regimen in the management of ACLF Secondary Objective To evaluate the six weeks mortality and length of hospital stay in ACLF patients treated with NAC Randomized, Double blind pilot study of IV N-Acetyl cysteine for the treatment of ACLF. Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. Efficacy will be assessed by clinical improvement in symptoms and signs of decompensated chronic liver disease (CLD). To assess safety degree of adverse reactions will be observed. Periodic assessments until 28 day will be done consisting of Physical exam, safety assessments, vital signs and lab tests. Dose of Drug: 72 hour regimen consisting of three doses of intravenous N-Acetyl cysteine will be used for a total dose of 300mg/kg. Number of Patients: 100 Accrual period: 15 months

NCT ID: NCT05036031 Not yet recruiting - Liver Cirrhosis Clinical Trials

Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study

TEA-ACLF
Start date: September 1, 2021
Phase:
Study type: Observational

The definition and diagnostic criteria of acute-on chronic liver failure (ACLF) differed evidently between the East and the West due to the difference in the underlying etiology. Liver transplantation is the most effective treatment to reverse the progress of ACLF and improve the survival rate of patients. The purpose of this study is to explore the accuracy of the two diagnostic criteria of EASL-CLIF and APASL ACLF in assessing the survival rate of patients with liver cirrhosis after LT.

NCT ID: NCT04960163 Not yet recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Incidence and Predictors of Bleeding Diathesis Development Due to DIC in Cirrhosis and ACLF Patients Undergoing CRRT

Start date: July 15, 2021
Phase:
Study type: Observational

ACLF and cirrhotic patient have deranged coagulation parameters and this coagulation parameters altered when this group of patients undergoing dialysis because of renal failure. this group of patients is also high risk of sepsis. Most common organ involved during sepsis leading to organ failure is renal. So, all this cascade increases the risk of bleeding as well as coagulation failure. Currently there are no studies evaluation the coagulation status in patients with cirrhosis undergoing dialysis. Further there are no studies evaluating the utility of these global tests of coagulation as a guide to judicious blood transfusion in these patients to prevent bleeding. Further there are no studies comparing the two different modalities of assessment.

NCT ID: NCT04822922 Not yet recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Safety of UC-MSC Transfusion for ACLF Patients

Start date: September 30, 2021
Phase: Phase 2
Study type: Interventional

Acute on chronic liver failure (ACLF) is a type of critically ill liver disease with high short-term mortality in liver disease. Liver transplantation is currently the only method to improve survival. Current clinical research evidence shows that mesenchymal stem cells can reduce the mortality of ACLF patients and are safe. This study aims to explore the safety of umbilical cord mesenchymal stem cells (UC-MSCs) in the treatment of ACLF. The study population is ACLF patients with 1-2 organ failures. To explore the safety of 3 doses of UC-MSCs, 16 patients need to be enrolled. The main observation indicators are the short-term and long-term safety of the treatment. All patients need to receive the standard medical treatment (SMT) at the same time. Stem cell treatment is given by intravenous infusion on the first, fourth, seventh, and tenth day. The occurrence of adverse events (AE) and serious adverse events(SAE) before and after the infusion will be observed. After the patient is discharged from the hospital, patients will be followed , the follow-up time is 5 years.

NCT ID: NCT04620148 Not yet recruiting - Clinical trials for Acute-On-Chronic Liver Failure

TAK-242 in Patients With Acute Alcoholic Hepatitis

Start date: December 2021
Phase: Phase 2
Study type: Interventional

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 alcohol-related cirrhosis due to alcoholic hepatitis resulting in acute-on-chronic liver failure.