Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
Acute on Chronic Hepatic FailureAcute Liver Failure2 moreThe study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver function.
Robotic vs. Laparoscopic vs. Open Living Donor Hepatectomy
End Stage Liver DiseaseAcute Liver Failure2 moreThis will be a study to examine the outcomes of open, laparoscopic, and robotic Living Donor Liver Transplantation (LDLT) procedures. The analysis will encompass 3,448 cases (1,724 donor-recipient pairs) from January 2011 to March 2023, documenting the transition between these surgical techniques, with a noted crossover in 2018.
Study of N-Acetylcysteine in Acute Liver Failure (ALF)
Acute Liver FailureFulminant Hepatic FailureThis proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with acute liver failure.
Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute...
Acute Liver FailureAcute Liver InjuryThis 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.
Hypothermia to Prevent High Intracranial Pressure in Patients With Acute Liver Failure
Acute Liver FailureIntracranial HypertensionTreatment 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 Effect of Prometheus (R) Liver Support Dialysis on Cerebral Metabolism in Acute Liver Failure...
Acute Liver FailureHepatic Encephalopathy1 moreThe 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.
N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
Acute Liver FailureHepatic EncephalopathyWe 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.
Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen...
Acute Liver FailureOBJECTIVES: 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.
High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure...
Acute Liver FailureAll the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.
Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry
Liver DiseasesLiver Neoplasms5 morePatient Registry aiming to provide regional evidence documenting the clinical merit of EUS (Endoscopic_ Ultrasound) guided liver biopsy, per local standard of practice, in patients with suspected liver disease indicated for an endoscopic intervention and a liver biopsy.