Elizabeth J. Carey, M.D.

Closed for Enrollment

• A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) Scottsdale/Phoenix, Ariz.

  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)

• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis (RESOLVE-IT) Scottsdale/Phoenix, Ariz.

  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.

• A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of EDP-305 in Subjects with Nonalcoholic Steatohepatitis (NASH) (NASH) Scottsdale/Phoenix, Ariz., La Crosse, Wis.

  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.

• A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia (LPCN 1148-21-001) Scottsdale/Phoenix, Ariz.

  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.

• A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis (REGENERATE) Scottsdale/Phoenix, Ariz.

  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.

• A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response) Scottsdale/Phoenix, Ariz.

  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.

• Adverse Outcomes and Mortality in Liver Transplant Scottsdale/Phoenix, Ariz.

  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.

   

   

• Cardiopulmonary Exercise Testing Use for Cardiovascular Risk Estimation and Frailty Assessment in Liver Transplant Candidates Scottsdale/Phoenix, Ariz.

  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.

• Dominant Strictures in Primary Sclerosing Cholangitis: a Survey-Based Study of Definitions and Clinical Practices Rochester, Minn., Scottsdale/Phoenix, Ariz.

  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.

• Exercise Intervention and Its Impact on Hospitalization - a Mulitcentered Study Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  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.