Active clinical trials for "Liver Failure"

The immune system of a patient can attack the liver or the kidney received from a donor (organ rejection). This can be prevented by treating these patients long-life with immunosuppressive drugs. Unfortunately, these drugs lead to numerous side effects and fail to prevent the rejection occurring months later after the transplantation (chronic rejection). Recently, it has been shown that a particular type of cells present in the bone marrow, namely Mesenchymal Stem Cells (MSC), when injected to a patient, suppress its immune system and increase success rates of blood cells transplantation. This outcome opens doors to investigate the potential of these cells to provide a valuable tool for improving solid organ transplantation without the need of high concentration of immunosuppressive drugs. The present project aims at evaluating the safety and tolerability of MSC administration after liver or kidney transplantation.

In order to determine the clinical application potential of adult stem cells we propose to investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or portal vein of five patients with chronic liver insufficiency and to identify any clinical benefit if such occurs. Objectives: To assess safety and treatment related toxicities To determine clinical benefit or deterioration by monitoring changes in liver function

A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.

Acute on chronic liver failure (ACLF) is a distinct entity where, because of severe acute hepatic injury, a rapid loss of liver function develops in a patient with previous chronic liver disease(4). These patients have severe hepatic dysfunction, and outcome is defined by functional hepatic reserve and extent of extra-hepatic organ failures(5). Renal failure is a frequent extra-hepatic organ failure, and its presence is an independent prognostic marker for mortality(12). The pathophysiological basis of renal dysfunction in patients with ACLF is different compared to those with decompensated cirrhosis (DC)(6). Systemic inflammation is the hallmark of ACLF, characterized by a cytokine storm wherein there is an increase in both pro- and anti-inflammatory cytokines, such as interleukin (IL)-6, IL-8, IL-1β, and IL-10, leading to circulatory dysfunction and organ failure(3). These patients therefore have a higher incidence and progression of acute kidney injury (AKI). Diagnosis of HRS-AKI in ACLF currently requires 48 h of volume repletion with albumin and diuretic withdrawal. Therefore waiting for 48 hours to start treatment with terlipressin can be associated with worsening of AKI stage, worsening of ACLF stage and thereby suboptimal treatment response and high mortality despite treatment response. Therefore early initiation of terlipressin as continuous infusion after volume repletion with IV albumin in ACLF-AKI is safe and prevents AKI progression by splanchnic vasoconstriction and improved renal perfusion.

Background: Previous studies have documented differences in the pharmacokinetics (PK) of a once daily FK506 formulation (Advagraf) based on patient ethnicity. These findings may be of particular relevance to the First Nations population who constitute a large and increasing segment of the liver transplant population in Canada. Aim: The purpose of the present study is to determine whether PK differences exist for Advagraf in First Nations compared to Caucasian liver transplant patients. Objectives: Document and compare PK determinations for Advagraf in First Nations and Caucasian patients with stable liver transplants. Document and compare CYP3A gene expression profiles in the two ethnic populations. Study Design: single-centre, open-label consecutive enrollment (N=8/group) self-identified adult First Nations and Caucasian ethnic cohorts 7 day steady state conversion (mg/mg/day) from twice to once daily FK506 formulation timed blood samples at 0, 1.5, 2, 4, 6, and 24 hours post medication PK determinations:concentration at zero time (C0), time to maximum concentration (Tmax),Area Under the Curve (AUC 0-24), apparent oral clearance (CLoral) and maximum concentration (Cmax) Methods: whole blood FK506 levels will be measured by UPLC tandem mass spectroscopy CYP3A allele analyses will be performed by Dr. Richard Kim, University of Western Ontario Relevance: The results of this study will serve to determine whether present guidelines for conversion of twice to once daily FK506 formulations need be modified for First Nations liver transplant patients.

This is a non-randomized, open-label, one treatment, four group, parallel group study to investigate the effect of impaired hepatic function on the pharmacokinetics of entrectinib in participants with different levels of hepatic function. Participants with mild, moderate or severe hepatic impairment ('Mild', 'Moderate' and 'Severe' groups), and control participants with normal hepatic function ('Normal' group) will each receive a single 100 mg dose of entrectinib after consumption of a standardized meal.

The goal of this in-silico clinical trial is to learn about the usability and clinical effectiveness of an interpretable deep learning framework (VAE-MLP) using counterfactual explanations and layerwise relevance propagation for prediction of post-hepatectomy liver failure (PHLF) in patients with hepatocellular carcinoma (HCC). The main questions it aims to answer are: To investigate the usability of the VAE-MLP framework for explanation of the deep learning model. To investigate the clinical effectiveness of VAE-MLP framework for prediction of post-hepatectomy liver failure in patients with hepatocellular carcinoma. In the usability trial the clinicians and radiologists will be shown the counterfactual explanations and layerwise relevance propagation (LRP) plots to evaluate the usability of the framework. In the clinical trial the clinicians and radiologists will make the prediction under two different conditions: with model explanation and without model explanation with a washout period of at least 14 days to evaluate the clinical effectiveness of the explanation framework.

This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP) score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the percentage of HCV-infected participants with hepatic insufficiency (the CP-B population) achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will also be given GZR + EBR at the beginning of the study; this will be done for the purpose of collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have hepatic insufficiency.

The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not.

To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic impairment in comparison to healthy subjects