A Study of Acute Alcohol Binge-Induced Gut Barrier Dysfunction and Upregulation of CYP2E1

Date Added
May 19th, 2026
PRO Number
Pro00150802
Researcher
Garth Swanson

List of Studies

Keywords
Alcohol, Liver, Stomach
Summary

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.

Institution
MUSC
Recruitment Contact
Keaveny (Katy) Donovan
8437927974
donova@musc.edu

MUSC Digestive Disease Research Core Center (DDRCC) Biorepository

Date Added
May 19th, 2026
PRO Number
Pro00149277
Researcher
Garth Swanson

List of Studies

Keywords
Bowel, Crohn's Disease, Digestive System, Hepatology, Inflammatory Bowel Disease, Liver, Non-interventional, Pancreas, Ulcerative colitis
Summary

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.

Institution
MUSC
Recruitment Contact
Katie Tremont
843-876-6377
tremontk@musc.edu

Case-Control Study of a Novel Test for the Early Detection of Hepatocellular Carcinoma in at-risk Patients with Cirrhosis

Date Added
May 1st, 2026
PRO Number
Pro00149583
Researcher
Don Rockey

List of Studies


Keywords
Cancer, Liver
Summary

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.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
(843)-876-8439
blanke@musc.edu

A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with noncirrhotic non-alcoholic steatohepatitis/metabolic dysfunctionassociated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis

Date Added
April 22nd, 2026
PRO Number
Pro00147517
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

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.

Institution
MUSC
Recruitment Contact
Josh Inman
843-876-4303
inmanj@musc.edu

A Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA-196 in Adults With the PiZZ Genotype Who Have Lung and/or Liver Disease Associated with Severe Alpha-1 Antitrypsin Deficiency

Date Added
April 9th, 2026
PRO Number
Pro00149000
Researcher
Charlie Strange

List of Studies


Keywords
Drug Studies, Liver, Lung, Pulmonary, Rare Diseases
Summary

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.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

Prospective Observational Study on the Natural History of Alpha-1 Antitrypsin Deficiency and Associated Liver Disease (ALPHATUDE)

Date Added
March 20th, 2026
PRO Number
Pro00147215
Researcher
Charlie Strange

List of Studies


Keywords
Liver, Lung, Pulmonary, Rare Diseases
Summary

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.

Institution
MUSC
Recruitment Contact
Gwen Hayden
843-792-8438
blantonm@musc.edu

Randomized study of larsucosterol in Alcohol-associated Hepatitis to confirm safety and efficacy of Treatment

Date Added
March 3rd, 2026
PRO Number
Pro00148994
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

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).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

Paxillin expression in human liver

Date Added
November 14th, 2025
PRO Number
Pro00147117
Researcher
Karim Besir

List of Studies

Keywords
Liver
Summary

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.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

BTX-302-001: A Phase 1/2 dose-exploration and dose-expansion study to evaluate the safety and efficacy of BEAM-302 in adult patients with Alpha-1 Antitrypsin Deficiency (AATD)-associated lung disease and/or liver disease.

Date Added
September 9th, 2025
PRO Number
Pro00146485
Researcher
Charlie Strange

List of Studies


Keywords
Genetics, Liver, Lung, Pulmonary, Rare Diseases
Summary

BTX-302-001 is a research study investigating the safety (how many side effects participants may have) and tolerability (how tolerable the side effects are) of BEAM-302 for individuals with Alpha-1 Antitrypsin Deficiency (AATD)-associated lung and/or liver disease. This study also aims to gather additional information regarding how BEAM-302 moves through the participant's body, how long it stays, and how long it takes to eliminate it - which is defined as the study drug's pharmacokinetics or "PK". Researchers would like to determine through this research study how BEAM-302 impacts the disease course (progression) of AATD in terms of AATD blood biomarkers, which are substances in blood that the body normally makes and will help show if an individual's AATD is improving, staying the same, or getting worse, along with lung and liver function testing results and the quality of life of participants.

This research study will be split into two main parts, Part A (which is for individuals with AATD-associated lung disease with no clear evidence of AATD-associated liver disease) and Part B (which is for individuals with AATD-associated liver disease). Additionally, each Part will be split into two separate cohorts, where one cohort will receive a single intravenous (IV) infusion of BEAM-302 (single-dose cohort) and the other will receive two IV infusions of BEAM-302 approximately 8 weeks apart (multi-dose cohort). Within these cohorts (single-dose and multi-dose), there are also separate smaller cohorts that will vary by the dose of BEAM-302 administered to participants, so a participant in this study could receive any of the following dosages - 15mg, 30mg, 60mg, 75mg, or 90mg. Overall, the research study will last up to around 29 months for each participant, depending on which cohort they are in, and their participation will be split into three main study periods - Screening, Dose and Dose-limiting toxicity (DLT), and Follow-up. It is also important to note that when a participant is receives their infusion(s) of BEAM-302 during the Dose and DLT period, the administration of the study drug will be done as a part of an in-patient hospital stay that will last up to 48 hours so that they can be closely monitored by the study team.

The key eligibility criteria for this study are that individuals (male or female) must be 18 to 70 years old, possess the PiZZ type of AATD, and have either AATD-associated lung disease with no clear evidence of AATD-associated liver disease or AATD-associated liver disease. There are additional eligibility criteria that must be met in order to be able to participate in the study, which will be assessed across up to 2 study visits that will occur during the Screening period.

Institution
MUSC
Recruitment Contact
Mary Hayden
843-792-8432
blantonm@musc.edu

Advanced Fibrosis Detection and a Predictive Diagnostic Model for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care

Date Added
July 3rd, 2025
PRO Number
Pro00145783
Researcher
Andrew Schreiner

List of Studies


Keywords
Diabetes, Liver, Obesity
Summary

This proposal evaluates the implementation of a novel, non-interruptive, electronic health record alert for metabolic dysfunction-associated steatotic liver disease (MASLD) fibrosis risk assessment in primary care patients with MASLD using a stepped wedge, cluster randomized design. We will evaluate the clinical outcome of advanced liver fibrosis detection and the implementation outcomes of adoption, penetration, fidelity, and sustainability. This work will generate generalizable data to dramatically enhance MASLD management in primary care.

Institution
MUSC
Recruitment Contact
Chloe Cooper
843-876-0448
coopechl@musc.edu



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