View clinical trials related to Acute Liver Failure.
Filter by: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.
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.
VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.
Acute liver failure (ALF) results from an abrupt loss of hepatic metabolic and synthetic function and leads to encephalopathy and potentially multi-organ dysfunction. Aetiologies include autoimmune and metabolic diseases, infectious agents and hepatotoxins. Worldwide, infectious hepatitis (A, B and E) is the most common cause. In Western Europe and the USA, ALF is most frequently caused by paracetamol intoxication. The MBT can produce immediate results to aid in decision making in patients with acute liver disease. Such a test may affect decision-making regarding transplantation in this setting, facilitate appropriate discharge from critical care to other hospital units and to home, provide point of care assessment of therapeutic interventions. The BreathID can potentially help in determining: - Parameter to include patients in transplant list (the UNOS 1A group) - Identification that patient deteriorates and needs extended hospitalization/referral to ICU/change in management - An addition to the MELD and or other scores to estimate risk in other acute patients - Additional information to that of other commonly utilized prognostic scoring systems The primary end-point of the study is to develop a model to predict deterioration of the liver disease, which incorporates measurements from the MBT along with other potential variables. The data collected will be used to develop a prediction model using data-mining methodology (linear and non-linear regression models, binary trees, neural networks, etc…). The predictive models may include measurements from the MBT, blood test results, as single measurements or as trend over time. The model that will be developed, will attempt to predict the disease deterioration vs. recovery accurately, at an earlier time point than the standard procedure. A threshold will then be determinate based on adequate sensitivity and specificity levels.
The specific aims of this study are (1) to determine the clinical phenotypes and natural history of hepatic RC and FAO disorders, (2) to determine the correlation between genotype and phenotype, (3) to determine if circulating biomarkers reflect diagnosis and predict liver disease progression and survival with the native liver, (4) to determine the clinical outcome of these disorders following liver transplantation, and (5) to develop a repository of serum, plasma, urine, tissue and DNA specimens that will be used in ancillary studies. To accomplish these aims, the ChiLDREN investigators at clinical sites (currently 15 sites) will prospectively collect defined data and specimens in a uniform fashion at fixed intervals in a relatively large number of subjects. Clinical information and DNA samples to be collected from subjects and their parents will enhance the potential for meaningful research in these disorders. A biobank of subject specimens and DNA samples will be established for use in ancillary studies to be performed in addition to this study.
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.
The aim of this study is to examine if high-volume plasma exchange has a positive effect on mortality in patients with acute 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.
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.
The main objective of this study is to investigate the effect of Prometheus liver support dialysis on intracranial pressure, cerebral metabolism and circulation in patients with acute liver failure.