To evaluate if daily oral administration of elafibranor 120 mg improves the time of event free survival compared to placebo in adults with Primary Sclerosing Cholangitis (PSC).
A single weight based dose of alcohol will be given to approximate an alcohol binge (aiming to achieve a blood alcohol concentration of approximately 0.08%) to investigate downstream effects on intestinal permeability and changes in hepatic steatosis. Several studies have been performed in humans under similar conditions and looking at similar things. The PI, Dr. Garth Swanson, conducted one of these studies previously. Here, participants will be given a weight-based dose (2mL vodka per kg body weight) of alcohol, with assessment of intestinal permeability via urine collection over the 24 hours directly following alcohol consumption, assessment of changes in hepatic steatosis by evaluation with fibroscan before and after alcohol consumption, and blood markers of endotoxemia and related inflammatory markers after. The weight-based dosing of alcohol was chosen to reflect previous studies looking at the effects of a single episode of alcohol binge use, with the goal of achieving a blood alcohol concentration of approximately 0.08%, the lower limit of what is needed to be considered an acute alcohol binge.
The goal of the DDRCC Biorepository is to collect human samples and health information to store for future research. Samples to be collected are blood, tissue (gastrointestinal, liver, pancreas and/or lymph nodes), stool, and cheek swabs. Participants may be eligible to enroll if scheduled for a clinical visit or surgical procedure during which these samples could be collected.
This study will enroll patients that were either diagnosed with hepatocellular cancer (HCC) in the past 6 weeks or have been diagnosed with cirrhosis but do not have HCC. Patients will have a blood sample collected to test if a new blood-based biomarker is accurate in the early detectection of HCC.
To investigate the safety, tolerability, PD, and PK of BI 3802876
when administered intravenously in single rising doses following
MABEL dose administration in adult patients with compensated
cirrhosis due to MASH.
This Phase III trial aims to investigate the efficacy and safety of survodutide (BI 456906) once weekly versus placebo on defined as resolution of steatohepatitis, reduction of liver fibrosis in liver biopsy and long-term improvement in clinical liver outcomes observed in trial participants with MASH and fibrosis stage F2-F3.
This is a Phase 1/2, open-label, multi-center clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of TSRA-196, a gene editing compound, in adults with severe alpha-1 antitrypsin deficiency (PiZZ genotype) and associated lung and/or liver disease. Participants will receive a single intravenous dose of TSRA-196 in a dose-escalation phase followed by dose-expansion cohorts.
The study will assess safety outcomes, pharmacokinetics, and changes in serum alpha-1 antitrypsin levels and lung function to determine whether TSRA-196 can safely increase functional AAT levels and inform selection of an appropriate dose for further clinical development.
This an observational study collecting data for up to 8 years on patients who have been diagnosed with PiZZ or PiSZ Alpha-1 Antitrypsin Deficiency with or without liver disease. Patients' clinical, medical, and laboratory data will be collected prospectively per routine care and questionnaires will be collected during the clinic visits with the hopes of getting a better understanding of the natural progress of lung and liver disease associated with Alpha-1 Antitrypsin Deficiency.
This study will test the hypothesis that treatment with larsucosterol is superior to treatment with placebo for improving the 90-day survival rate and 90-day transplant-free surival rate in participants with severe alcoholic hepatitis (AH).
We wish to examine human liver to determine whether and to what extent paxillin is expressed (using immunohistochemistry). Existing liver specimens will be identified by ICD-10 search to identify patients with MASLD who have undergone liver biopsy within the last 5 years.