Publications
Annals of HepatologyDec 2024 |
29
101599-101599
DOI:
10.1016/j.aohep.2024.101599

OP-1 LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: INTERIM 2-YEAR RESULTS FROM THE ASSURE STUDY

Trivedi, Palak J.; Levy, Cynthia; Kowdley, Kris V.; Gordon, Stuart C.; Bowlus, Christopher L.; Hurtado, Maria Carlota Londoño; Hirschfield, Gideon M.; Gulamhusien, Aliya F.; Lawitz, Eric J.; Villamil, Alejandra; Cetina, Alma Ladron de Guevara; Mayo, Marlyn J.; Younes, Ziad H.; Shibolet, Oren; Yimam, Kidist K.; Pratt, Daniel S.; Heo, Jeong; Morgera, Ulrike; Andreone, Pietro; Kremer, Andreas E.; Corpechot, Christophe; Goel, Aparna; Peyton, Adam; Elbeshbeshy, Hany; Crittenden, Daria B.; Heusner, Carrie; Proehl, Sarah; Zhou, Shuqiong; McWherter, Charles A.
Product Used
Genes
Abstract
Introduction and Objectives Seladelpar reduces biochemical markers of cholestasis and pruritus in patients with primary biliary cholangitis. ASSURE (NCT03301506) is an ongoing, open-label, long-term Phase 3 trial of seladelpar in patients rolling over from Phase 3 RESPONSE (NCT04620733) or legacy studies (NCT03602560, NCT02955602, NCT03301506, and NCT04950764). We report interim 2-year efficacy and safety results. Patients / Materials and Methods Patients with insufficient response/intolerance to ursodeoxycholic acid could enroll in ASSURE. Key endpoints were composite biochemical response (alkaline phosphatase [ALP]
Product Used
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