Obeticholic Acid in Pediatric Subjects With Biliary Atresia
Status:
Recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
Summary
This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study
with an optional open-label extension (OLE) to assess the safety, tolerability, and
pharmacokinetics of obeticholic acid (OCA) in pediatric subjects with biliary atresia with
successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterosomy). The OLE will
continue to evaluate safety, tolerability, pharmacodynamics, and efficacy of OCA. In
addition, a change in vitamin A and D levels, and where possible the degree of change in
liver stiffness, will be assessed during the OLE.