A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (ELASCOPE)

Date Added
July 23rd, 2026
PRO Number
Pro00150319
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

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).

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

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 Phase IIa double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 3802876 in participants with compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Date Added
April 28th, 2026
PRO Number
Pro00148327
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

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.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768439
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



-- OR --