Elizabeth J. Carey, M.D.

The purpose of this study is to to assess the effects of different Oral Vancomycin (OV) doses on the clinical and biochemical course in adult patients with Primary Sclerosing Cholangitis (PSC).

The purpose of this study is to evaluate the effects of two doses of MBX-8025 in patients with primary biliary cirrhosis and an inadequate response to ursodeoxycholic acid

The purpose of this study is to evaluate the safety and effectiveness of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

The purpose of this double-blind study is to obtain the most unbiased assessment of clinical safety and efficacy with the doses of EDP-305 being studied.

The purose of this study is to assess the effectiveness, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in adults with primary biliary cholangitis (PBC).

The purpose of this study is to evaluate the effectiveness and safety of obeticholic acid in patients with primary sclerosing cholangitis, evaluating its effects on specific liver function indicators and biochemistry.

The primary objectives of this study are to evaluate the safety and effectiveness of obeticholic acid treatment compared to placebo on both tissue structure improvement and liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of GS-9674 in adults who have primary sclerosing cholangitis.

Primary Biliary Cirrhosis (PBC) is a serious, life--threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.

This study is being conducted to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus (itch) in participants with primary biliary cholangitis (PBC). Participants will be treated with either placebo or one of the 4 dose regimens of GSK2330672 (20 milligram [mg], 90 mg or 180 mg taken once daily or 90 mg twice daily). Subjects on GSK2330672 will also receive placebo tablets to maintain blinding. The total duration of a subject's participation will be up to 45 days of screening and 24 weeks of study including follow-up.

The primary aim of this study is to use an MRI-based Muscle Assessment Score (MAsS), which includes both muscle volume and fat infiltration, at the transplant candidacy evaluation and other follow-up MRI examinations as clinically indicated, as an objective, standardized, and quantitative measure of muscle health and explore the link between muscle composition and adverse outcomes and mortality. In addition, there are growing numbers of high-risk donor livers, such as presenting with steatosis or exposed to prolonged ischemia time.

A secondary aim is to gather information on the association between transplant recipient muscle composition and donor liver characteristics to one-year post-LT adverse outcomes and mortality.

The purpose of this study is to evaluate the safety and effectiveness of curcumin used in patients with primary sclerosing cholangitis.

The purpose of this study is to determine agreement between cardiopulmonary exercise testing and cardiac stress testing (SOC) for the identification of subclinical coronary artery disease in liver transplant candidates, to determine agreement between cardiopulmonary exercise testing and dobutamine stress echocardiogram (SOC) for the identification of cirrhotic cardiomyopathy in liver transplant candidates, and to determine agreement between peak oxygen consumption from cardiopulmonary exercise testing and the liver frailty index or the six-minute walk test (SOC), for the identification of frailty in liver transplant candidates.

The purpose of this study is to identify consensus among clinicians about the definitions, perceptions and practices for management of dominant strictures in primary sclerosing cholangitis.

Skeletal muscle abnormalities (sarcopenia) and frailty are common complications seen in patients with end-stage liver disease. The presence of these complications portends poor prognosis. The purpose of this study is to assess the impact of a formal home based video strengthening program (REST) on sarcopenia and frailty. We also want to assess the impact of this exercise program on complication rates, hospitalization, on quality of life (QOL) and on survival.

The purpose of this study is to examine the safety, tolerability, and efficacy of daily dosing with vidofludimus calcium over a 6-month period on the clinical course and progression of primary sclerosing cholangitis.