Phase 3, placebo-controlled, randomized study to evaluate the safety and efficacy of seladelpar in patients with Primary Biliary Cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid (Ursodeoxycholic Acid, [UDCA]).
Project objectivesThe objectives of the projects are attributable to the fields of interest of the UDR of Clinical Medicine and Hepatology: 1. Innovative treatments of advanced metabolic liver disease (MAFLD/NASH) with international multicenter intervention trials; 2. Innovative treatments of Primary Biliary Cholangitis (PBC); 3. Scouting and characterization of MAFLD/NASH and risk factors for the evolution of chronic liver disease, including any genetic predispositions; 4. Scouting for cases of chronic Hepatitis C Virus (HCV) infection that are currently susceptible to effective and well-tolerated treatment, even in elderly patients or with advanced liver disease; 5. Characterization and innovative treatments of sarcopenia in advanced chronic liver disease or malignancy; 6. Characterization of malignant and benign hepatic nodules using non-invasive techniques of temporary elastometry. |
Start and end date |
| April 2021 - January 2023 |
Project Manager |
| Vespasiani - Principal Investigator |
Coordinating institution of the project |
| UCBM |
Funding source(s). |
| CymaBay Therapeutics, Inc. |
