170 Clinical Trials for Various Conditions
The clinical trail will assess the safety of miroliverELAP for the treatment of acute liver failure without underlying chronic liver disease. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver.
Acute Liver Failure, Acute Liver Injury, Drug Induced
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 failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)
Acute-On-Chronic Liver Failure, Ascites
The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days. During the stay, one oral dose of soticlestat will be given and the participant will be monitored. The clinic staff will follow up with the participant about a week after discharge from the clinic.
Hepatic Impairment, Healthy Volunteers
Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.
Liver Diseases, Liver Cirrhosis, Acute-On-Chronic Liver Failure, Liver Transplant; Complications
Critically-ill patients with liver disease are at high risk of developing sarcopenia and intensive care unit (ICU)-acquired weakness, which are associated with mortality and other poor outcomes. Early physical rehabilitation has shown benefit in ICU settings, but has not been studied in ICU patients with acute and chronic liver failure. Cycle ergometry, or stationary cycling in passive and active modes, may be especially beneficial to such patients due to their high prevalence of severe physical deconditioning and variable mentation. The aim of this study is to examine the feasibility, safety, and benefit of cycle ergometry over standard physical and occupational therapy (PT/OT) in critically-ill patients who have acute or chronic liver disease.
Liver Cirrhoses, Liver Failure, ICU Acquired Weakness
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. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF. Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period. The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution. The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards. The Follow-up Period for subjects in both groups will be 90 days.
Acute-On-Chronic Liver Failure
1. Further characterize the incidence of hyperfibrinolysis in cirrhotics 2. Correlate hyperfibrinolysis with 1. hepatitis C 2. alcoholic liver disease 3. the subset of a\&b with renal failure with and without dialysis 3. Better describe the hyperfibrinolytic ROTEM profile in cirrhotics
Cirrhosis
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.
Acute Liver Failure, Fulminant Hepatic Failure, Primary Graft Non-Function, Surgically-Induced Liver Failure
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.
Acute Liver Failure
This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: * safety and tolerability; * metabolism of the compound to glutamine and phenylacetylglutamine (PAGN); * its effect on circulating ammonia levels and neurological function in patients with and without impaired renal function after continuous infusion at different infusion rates. Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day follow-up visit post infusion. It is anticipated that this early safety and tolerability study, with appropriate PK/PD data, will lead to a development program for the use of OCR-002 in the treatment of hyperammonemia either due to ALF or possibly other liver conditions. The hypotheses are: * Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune hepatitis, viral hepatitis or indeterminate etiologies. * A dose of 10-20g/24h (0.42-.83g/h) will achieve steady state plasma concentrations within 6-12h with little additional accumulation in the ALI/ALF setting. * Treatment with OCR-002 will reduce ammonia and improve neurological function in patients with acute liver failure/severe acute liver injury.
Acute Liver Failure, Acute Liver Injury
The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day 91, with follow-up Protocol VTI-208E providing additional survival data up to a maximum of 5 years that will be included, as available, through VTI-208 study termination (after the last surviving enrolled subject completes Study Day 91). Secondary objectives are to determine the proportion of survivors at Study Days 28 and 91. Exploratory objectives are to evaluate the ability of ELAD to stabilize liver function, measured using the Model for End Stage Liver Disease (MELD)-based time to progression (TTP) up to Study Day 91, and the proportion of progression-free survivors (PFS) up to Study Days 28 and 91. Progression is defined as death or the first observed increase of at least 5 points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to both End of Study Days 28 and 91 following Randomization.
Acute Alcoholic Hepatitis
The purpose of this research study is to determine whether liver cell transplantation can provide help for patients with liver failure who are unlikely to survive without some form of liver support. The goal of this research study is to determine if liver cell transplants can be effective until a liver transplant is received or until patients recover from their liver failure.
Liver Failure Acute
The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.
Cirrhosis
The PALF study group began with 20 sites and now continues with 12 sites (11 in the United States and 1 in Canada) in the new funding period. The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.
Acute Liver Failure, Hepatic Encephalopathy
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). Patients may or may not also demonstrate abnormalities in bilirubin and/or creatinine. Treatment consists of a 5 mg/kg loading dose followed by 20 mg/kg/day via continuous infusion. The treating physician is expected to administer supportive therapy of his/her choosing but consistent with best practices. Legalon® SIL will be stopped when coagulopathy is no longer present, and when liver function tests have returned significantly towards the normal range. Patients will be followed 7-14 days after the end of Legalon® SIL therapy with follow up lab studies.
Amatoxin Poisoning, Amanita Poisoning, Mushroom Poisoning, Liver Failure
This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with acute liver failure.
Acute Liver Failure, Fulminant Hepatic Failure
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 therapy for FHF plus the ELAD® system, or standard medical therapy alone, with the latter defined as conventional therapy for FHF determined to be clinically appropriate by the treating physician.
Fulminant Hepatic Failure
The investigators research will examine the safety and efficacy of hepatocyte transplantation in the patient with acute liver failure without history of chronic disease. The investigators will study the effectiveness in providing a bridge of support for patient survival until whole organ transplantation is possible. This support may also be a bridge to recovery; by allowing the native liver to recover so that orthotopic liver transplant is not necessary. The investigators will also study the safety and efficacy of hepatocyte transplantation in the patient with chronic liver disease. Underlying etiologies of chronic disease may arise from cirrhosis, fibrosis or inherited metabolic disorders. The investigators will examine cell transplantation in end-stage patients not eligible for whole organ transplant. These patients may benefit with an amelioration of symptoms that will allow other therapeutic treatments. The investigators study will also examine the ability of transplanted hepatocytes to treat inherited metabolic diseases (ex., Crigler-Najjar Disease, Familial Hypercholesterolemia, Urea Cycle Disorders). Cell transplant may also act as a 'bridge' to whole organ transplant or improve function, permitting easier disease control through traditional therapy.
Liver Failure
Treatment options in patients with high intracranial pressure due to acute liver failure are limited. This study intends to evaluate the effect of prophylactic hypothermia on preventing high intracranial pressure and compromised cerebral oxidative metabolism.
Acute Liver Failure, Intracranial Hypertension
The purpose of this study is to collect clinical and epidemiological data as well as serum, plasma, urine, tissue and DNA samples on individuals who have acute liver failure and on individuals who have acute liver injury, a less severe group of patients who have coagulopathy but do not reach the threshold of encephalopathy.
Acute Liver Failure, Fulminant Hepatic Failure, Acute Liver Injury
We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antidote or other specific treatment is available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver Failure (PALF) Study Registry.
Acute Liver Failure, Hepatic Encephalopathy
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.
Fulminant Hepatic Failure
OBJECTIVES: I. Determine the safety and efficacy of a short course (72 hours) of intravenous acetylcysteine in patients with acute liver failure for whom no antidote or specific treatment is available.
Acute Liver Failure
This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects.
Hepatic Impairment
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.
Hepatic Impairment
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.
Hepatitis C, Cirrhosis, Portal Hypertension, With or Without Liver Decompensation
The purpose of this study is to understand mechanisms associated with the development of coma during hepatic failure. As of today, those mechanisms are not understood and it is difficult to intervene and prevent coma development which is often associated with mortality. Understanding the mechanism involved, may allow us to prevent coma and develop new therapies to treat this disease.
Acute and Chronic Hepatic Failure With Developing Coma
Evaluate on how well the ELAD system works in treating people with liver failure.
Acute Hepatitis, Chronic Hepatitis
The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196.
Hepatic Insufficiency
This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.
Hepatic Insufficiency